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CompletedNCT00281580Updated Mar 27, 2014Results posted

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

A Phase 3 interventional study of Amlodipine 5 mg and Placebo in Hypertension, sponsored by Boehringer Ingelheim. Completed at 136 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-27.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,461
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

02

Conditions studied

  • Hypertension

Browse trials for

03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,461 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria:

Main Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and \<=119 mmHg Main

Exclusion criteria:

Exclusion Criteria:

  1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
  2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double
Enrollment
1,461 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo once daily for eight weeks

    Drug: Placebo

  • Experimental
    Telmisartan 20 mg

    Telmisartan 20 mg once daily for eight weeks

    Drug: Telmisartan 20 mg

  • Experimental
    Telmisartan 40 mg

    Telmisartan 40 mg once daily for eight weeks

    Drug: Telmisartan 40 mg

  • Experimental
    Telmisartan 80 mg

    Telmisartan 80 mg once daily for eight weeks

    Drug: Telmisartan 80 mg

  • Experimental
    Amlodipine 2.5 mg

    Amlodipine 2.5 mg once daily for eight weeks

    Drug: Amlodipine 2.5 mg

  • Experimental
    Amlodipine 5 mg

    Amlodipine 5 mg once daily for eight weeks

    Drug: Amlodipine 5 mg

  • Active comparator
    Amlodipine 10 mg

    Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily

    Drug: Amlodipine 5 mg · Drug: Amlodipine 10 mg

  • Experimental
    Telmisartan 20 / Amlodipine 2.5

    Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks

    Drug: Telmisartan 20 mg · Drug: Amlodipine 2.5 mg

  • Experimental
    Telmisartan 20 / Amlodipine 5

    Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks

    Drug: Telmisartan 20 mg · Drug: Amlodipine 5 mg

  • Experimental
    Telmisartan 20 / Amlodipine 10

    Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

    Drug: Amlodipine 10 mg · Drug: Telmisartan 20 mg · Drug: Amlodipine 5 mg

  • Experimental
    Telmisartan 40 / Amlodipine 2.5

    Telmisartan 40 / Amlodipine 2.5 for eight weeks

    Drug: Amlodipine 2.5 mg · Drug: Telmisartan 40 mg

  • Experimental
    Telmisartan 40 / Amlodipine 5

    Telmisartan 40 / Amlodipine 5 for eight weeks

    Drug: Amlodipine 5 mg · Drug: Telmisartan 40 mg

  • Experimental
    Telmisartan 40 / Amlodipine 10

    Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

    Drug: Telmisartan 40 mg · Drug: Amlodipine 10 mg · Drug: Amlodipine 5 mg

  • Experimental
    Telmisartan 80 / Amlodipine 2.5

    Telmisartan 80 / Amlodipine 2.5 for eight weeks

    Drug: Amlodipine 2.5 mg · Drug: Telmisartan 80 mg

  • Experimental
    Telmisartan 80 / Amlodipine 5

    Telmisartan 80 / Amlodipine 5 mg for eight weeks

    Drug: Telmisartan 80 mg · Drug: Amlodipine 5 mg

  • Experimental
    Telmisartan 80 / Amlodipine 10

    Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

    Drug: Amlodipine 5 mg · Drug: Telmisartan 80 mg · Drug: Amlodipine 10 mg

Interventions

  • DrugAmlodipine 5 mg

    Amlodipine 5 mg once daily for two weeks

  • DrugPlacebo

    Placebo to Telmisartan and Amlodipine once daily for eight weeks

  • DrugTelmisartan 20 mg

    Telmisartan 20 mg once daily for eight weeks

  • DrugTelmisartan 40 mg

    Telmisartan 40 mg once daily for eight weeks

  • DrugAmlodipine 10 mg

    Amlodipine 10 mg once daily for six weeks

  • DrugTelmisartan 20 mg

    Telmisartan 20 mg once daily for eight weeks

  • DrugTelmisartan 80 mg

    Telmisartan 80 mg once daily for eight weeks

  • DrugAmlodipine 10 mg

    Amlodipine 10 mg once daily for six weeks

  • DrugTelmisartan 20 mg

    Telmisartan 20 mg once daily for eight weeks

  • DrugAmlodipine 5 mg

    Amlodipine 5 mg once daily for two weeks

  • DrugAmlodipine 5 mg

    amlodipine 5g once daily for eight weeks

  • DrugTelmisartan 20 mg

    Telmisartan 20 mg once daily for eight weeks

  • DrugAmlodipine 5 mg

    Amlodipine 5 mg once daily for eight weeks

  • DrugAmlodipine 5 mg

    amlodipine 5mg once daily for eight weeks

  • DrugAmlodipine 2.5 mg

    Amlodipine 2.5 mg once daily for eight weeks

  • DrugAmlodipine 2.5 mg

    Amlodipine 2.5 mg once daily for eight weeks

  • DrugAmlodipine 10 mg

    Amlodipine 10 mg once daily for six weeks

  • DrugAmlodipine 2.5 mg

    Amlodipine 2.5 mg once daily for eight weeks

  • DrugTelmisartan 80 mg

    Telmisartan 80 mg once daily for eight weeks

  • DrugTelmisartan 80 mg

    Telmisartan 80 mg once daily for eight weeks

  • DrugAmlodipine 5 mg

    Amlodipine 5 mg once daily for two weeks

  • DrugAmlodipine 2.5 mg

    Amlodipine 2.5 mg once daily for eight weeks

  • DrugTelmisartan 40 mg

    Telmisartan 40 mg once daily for eight weeks

  • DrugTelmisartan 40 mg

    Telmisartan 40 mg once daily for eight weeks

  • DrugAmlodipine 5 mg

    amlodipine 5g once daily for two weeks

  • DrugAmlodipine 5 mg

    Amlodipine 5 mg once daily for eight weeks

  • DrugTelmisartan 40 mg

    Telmisartan 40 mg once daily for eight weeks

  • DrugTelmisartan 80 mg

    Telmisartan 80 mg once daily for eight weeks

  • DrugAmlodipine 10 mg

    Amlodipine 10 mg once daily for six weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)

    Observed results

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))

  2. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  3. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

    Observed results

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  4. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  5. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

    Observed results

    Time frame: End-of-study visit (LOCF)

  6. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  7. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  8. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)

    Observed results

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  9. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  10. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

    Observed results

    Time frame: Up to 8 weeks (LOCF)

  11. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

  12. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

    Observed results

    Time frame: Up to 8 weeks (LOCF)

  13. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

  14. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

Secondary outcomes

  1. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  2. Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  3. Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

    Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  4. DBP Control

    DBP control is defined as DBP \< 90 mmHg - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  5. DBP Response

    DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  6. SBP Response

    SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  7. BP Normality

    No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  8. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

    Observed results - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  9. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP

    Observed results - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  10. Change From Baseline in ABPM 24-hour Mean DBP

    Observed results - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  11. Change From Baseline in ABPM 24-hour Mean SBP

    Observed results - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  12. Orthostatic Change in Trough Cuff Mean DBP

    Calculated as seated minus standing for all patients - key combination therapies

    Time frame: Week 8

  13. Orthostatic Change in Trough Cuff Mean SBP

    Calculated as seated minus standing for all patients - key combination therapies

    Time frame: Week 8

  14. Change From Baseline in Seated Trough Pulse Rate

    Observed results for all patients - key combination therapies

    Time frame: End-of-study visit (LOCF)

  15. Change From Baseline in Seated Trough Cuff Mean SBP

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

  16. Change From Baseline in Standing Trough Cuff Mean DBP

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

  17. Change From Baseline in Standing Trough Cuff Mean SBP

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

    Time frame: Up to 8 weeks (LOCF)

  18. DBP Control

    DBP control is defined as DBP \< 90 mmHg - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  19. DBP Response

    DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  20. SBP Response

    SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  21. BP Normality

    No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  22. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

    Observed results for mod-sev patients - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  23. Change From Baseline in ABPM 24-hour Mean DBP

    Observed results for mod-sev patients - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  24. Change From Baseline in ABPM 24-hour Mean SBP

    Observed results for mod-sev patients - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  25. Orthostatic Change in Trough Cuff Mean DBP

    Calculated as seated minus standing for mod-sev patients - key combination therapies

    Time frame: Week 8

  26. Orthostatic Change in Trough Cuff Mean SBP

    Calculated as seated minus standing for mod-sev patients - key combination therapies

    Time frame: Week 8

  27. Change From Baseline in Seated Trough Pulse Rate

    Observed results for mod-sev patients - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

  28. Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)

    Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).

    Time frame: 8 weeks

Other outcomes

  1. Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP

    Observed results for key combination therapies

    Time frame: Baseline to nominal week over the trial

  2. BP Control

    Percentage of responders (SBP\<140 mmHg and DBP\<90 mmHg) for all patients - key combination therapies

    Time frame: End-of-study (up to 8 weeks) visit (LOCF)

  3. Change From Baseline in Seated Trough Cuff DBP

    Observed results for mod-sev patients - key combination therapies

    Time frame: Nominal week over the trial

  4. BP Control

    Responders SBP\<10 mmHg and DBP\<90 mmHg) for mod-sev patients - key combination therapies

    Time frame: Up to 8 weeks (LOCF)

07

Results

Posted Apr 28, 2010

Participant flow

Participant flow — Overall Study
MilestonePlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Started4642130135444644471431294814614250140129
Completed3941125118404339461351174413612943133116
Not completed715174351812410137713
Withdrew: Adverse event2024101016058233
Withdrew: Protocol violation0011001020120113
Withdrew: Withdrawal by subject3011122014112215
Withdrew: Lack of efficacy2116200000010210
Withdrew: Lost to follow-up0003010121101000
Withdrew: Randomised in error; pregnancy; moving0002001021112012

Outcome measures

PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)

Observed results

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
Reported as:
Mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
mmHgTelmisartan 0 mg (T0)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)-13 ± 8.8-16.4 ± 7.8-16.2 ± 8.9-16.9 ± 8.6
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
mmHgTelmisartan 0 mg (T0)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)-12.5 ± 0.5-16.8 ± 0.6-16.6 ± 0.4-17.2 ± 0.4
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

Observed results

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
mmHgPlacebo (Pl)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)-12.3 ± 9.7-14.9 ± 8.8-15.6 ± 8.1-18.6 ± 7.7
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
mmHgPlacebo (Pl)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)-12.2 ± 0.5-15.3 ± 0.6-16.2 ± 0.4-19.3 ± 0.4
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

Observed results

Time frame:
End-of-study visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)-5.9 ± 9.4-13.2 ± 9-13.1 ± 10.1-13.6 ± 8.7-18 ± 7.8-15.7 ± 6.5-18.7 ± 7-16.2 ± 8.2-16 ± 7.6-19.6 ± 7.9-15.3 ± 7.5-17.8 ± 8.5-19.6 ± 7.9-10.4 ± 9.9-13 ± 7.9-16.5 ± 7.1
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)-6.2 ± 1.2-13.8 ± 1.3-13.4 ± 0.7-14 ± 0.7-18.3 ± 1.2-15.9 ± 1.2-19.3 ± 1.3-16.9 ± 1.2-16.5 ± 0.7-20.2 ± 0.7-15.7 ± 1.2-18.2 ± 0.7-20.1 ± 0.7-10.6 ± 1.2-13.4 ± 0.7-17.11 ± 0.7
PrimaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
mmHgTelmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)-13.8 ± 1.2-13.4 ± 0.7-14 ± 0.7-18.3 ± 1.2-15.9 ± 1.2-19.3 ± 1.3-16.9 ± 1.2-16.5 ± 0.7-20.2 ± 0.7-15.7 ± 1.2-18.2 ± 0.7-20.1 ± 0.7-10.6 ± 1.2-13.4 ± 0.7-17.1 ± 0.7
SecondaryChange From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)-2.5 ± 1.8-15.1 ± 1.9-14.6 ± 1.1-14.3 ± 1.1-18.8 ± 1.9-21 ± 1.9-24.4 ± 2-21.9 ± 1.8-21.8 ± 1.1-24.7 ± 1.1-17.4 ± 1.8-22.1 ± 1-26.4 ± 1.1-11.4 ± 1.8-15.4 ± 1.1-20.7 ± 1.1
SecondaryChange From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP-4.9 ± 1.2-10.4 ± 1.3-10 ± 0.8-11.1 ± 0.8-14.9 ± 1.3-13.1 ± 1.3-16.9 ± 1.3-15.8 ± 1.2-13.6 ± 0.7-18.4 ± 0.8-13.4 ± 1.2-16.2 ± 0.7-19 ± 0.7-8.1 ± 1.2-11.3 ± 0.7-14.6 ± 0.8
SecondaryChange From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP-0.5 ± 1.9-13.2 ± 2-13.2 ± 1.1-12.9 ± 1.1-17.4 ± 1.9-18.9 ± 1.9-22.3 ± 2-20.3 ± 1.8-20 ± 1.1-22.8 ± 1.1-17.4 ± 1.9-21.2 ± 1.1-24.9 ± 1.1-9.1 ± 1.9-14.7 ± 1.1-19.1 ± 1.2
Other pre-specifiedChange From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP

Observed results for key combination therapies

Time frame:
Baseline to nominal week over the trial
Reported as:
Mean · mmHg
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Week 2-14.5 ± 8.76-14.4 ± 7.62-15.3 ± 7.87-14.6 ± 6.76
Week 4 (N=133, 115, 135, 129)-16.0 ± 7.24-18.1 ± 8.52-17.2 ± 7.56-18.8 ± 7.06
Week 6 (N=134, 118, 131, 124)-17.1 ± 8.59-19.0 ± 8.30-18.0 ± 8.02-20.0 ± 8.18
Week 8 (N=133, 112, 132, 121)-16.3 ± 7.42-19.5 ± 8.03-18.3 ± 8.28-20.0 ± 7.61
SecondaryDBP Control

DBP control is defined as DBP \< 90 mmHg - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Number · percentage of participants
DBP Control
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
DBP Control71.682.174.885.3
SecondaryDBP Response

DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Number · percentage of participants
DBP Response
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
DBP Response80.991.988.891.2
SecondarySBP Response

SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Number · percentage of participants
SBP Response
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
SBP Response91.596.787.494.9
Other pre-specifiedBP Control

Percentage of responders (SBP\<140 mmHg and DBP\<90 mmHg) for all patients - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Number · percentage of participants
BP Control
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
BP Control58.975.665.776.5
SecondaryBP Normality

No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Number · percentage of participants
BP Normality
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
No (SBP>=140 and/or DBP>=90)41.124.434.323.5
High Normal (140>SBP>=130 and 90>DBP>=85)28.430.130.122.1
Normal (130>SBP>=120 and 85>DBP>=80)21.332.525.939.7
Optimal (SBP<120 and DBP<80)9.2139.814.7
SecondaryChange From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

Observed results - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Hour 1-10.7 ± 9.5-15.4 ± 11.6-12.7 ± 9.9-13.4 ± 9.7
Hour 2-9.8 ± 11.7-15 ± 12.2-13.4 ± 9.5-14.6 ± 12.4
Hour 3-11.2 ± 13.2-14.1 ± 12.6-14.8 ± 11.6-15.4 ± 12
Hour 4-11.3 ± 11.8-16.5 ± 13.2-15.6 ± 11.7-15.8 ± 10.8
Hour 5-13.1 ± 11-14.1 ± 14.4-16.3 ± 14.3-15.7 ± 10.9
Hour 6-10.9 ± 11.6-14.5 ± 12.4-14.6 ± 9.9-16.4 ± 11
Hour 7-12.8 ± 10.2-15.6 ± 13.9-12.9 ± 10.4-15.7 ± 14
Hour 8-12.1 ± 12.3-17.4 ± 13.6-12.7 ± 13.6-17.1 ± 12.9
Hour 9-13.1 ± 10.3-15.7 ± 14.4-14.3 ± 14.3-17.2 ± 13.8
Hour 10-11.8 ± 10.3-13.8 ± 13.5-14.7 ± 15.7-18.5 ± 12.9
Hour 11-11.2 ± 12.9-14.4 ± 11.9-15.1 ± 13.1-16.1 ± 12.8
Hour 12-12 ± 11.3-13.3 ± 12.9-12.5 ± 14.8-15.7 ± 12.2
Hour 13-10.3 ± 11.7-14.7 ± 14.3-14.1 ± 13.5-15.1 ± 10.6
Hour 14-8.9 ± 13.2-14.8 ± 14.1-13.4 ± 13.4-11 ± 14.9
Hour 15-10.3 ± 16-11.5 ± 14.3-11.9 ± 14.8-10 ± 12.7
Hour 16-10.1 ± 15-10.3 ± 15.4-11.3 ± 12-12.2 ± 13.6
Hour 17-9.8 ± 13.7-10.4 ± 14.4-11.2 ± 12.5-11.5 ± 13.1
Hour 18-11.9 ± 15-9.9 ± 12.4-10.3 ± 12.3-12.2 ± 11.9
Hour 19-9.1 ± 10.9-10.5 ± 13.7-11.9 ± 10.4-13.2 ± 11.3
Hour 20-11 ± 11.9-9.9 ± 12.4-12.6 ± 11.1-15.9 ± 11.1
Hour 21-10.4 ± 13-8.9 ± 13.2-8.5 ± 12.7-14.8 ± 9.7
Hour 22-11.1 ± 12.6-9.8 ± 13.7-9.7 ± 12.9-15.4 ± 9.9
Hour 23-9.8 ± 11.3-13.3 ± 13.4-9.9 ± 12.2-14.6 ± 9.4
Hour 24-11.1 ± 9.5-12.6 ± 11.5-12 ± 13.1-13.1 ± 11.9
SecondaryChange From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP

Observed results - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Hour 1-18.7 ± 12.9-20.2 ± 16.5-19.1 ± 13.4-17.5 ± 15.9
Hour 2-13.1 ± 16.5-22.0 ± 17.9-20.5 ± 16.6-21.9 ± 15.9
Hour 3-15.3 ± 16.1-17.9 ± 18.9-21.1 ± 17.8-22.4 ± 16.8
Hour 4-18.0 ± 16.9-24.4 ± 20.6-22.5 ± 16.5-23.8 ± 15.9
Hour 5-19.3 ± 13.6-21.1 ± 19.8-25.3 ± 18.1-24.0 ± 16.5
Hour 6-14.1 ± 14.0-22.6 ± 14.9-21.6 ± 15.9-24.6 ± 14.8
Hour 7-17.8 ± 14.5-24.3 ± 19.5-19.9 ± 17.7-22.4 ± 15.6
Hour 8-18.8 ± 17.1-24.1 ± 20.8-20.3 ± 18.6-21.8 ± 15.5
Hour 9-20.3 ± 15.6-24.9 ± 20.0-22.0 ± 19.2-25.6 ± 16.1
Hour 10-20.0 ± 16.0-22.9 ± 19.2-22.5 ± 19.3-26.8 ± 19.3
Hour 11-18.7 ± 17.4-20.9 ± 19.8-23.2 ± 16.7-24.9 ± 15.7
Hour 12-18.4 ± 16.8-20.3 ± 19.5-19.7 ± 19.1-25.0 ± 17.3
Hour 13-18.5 ± 16.9-21.7 ± 23.5-22.7 ± 18.3-24.7 ± 14.6
Hour 14-16.7 ± 17.6-21.6 ± 20.8-21.7 ± 19.2-20.2 ± 16.9
Hour 15-15.7 ± 18.1-19.4 ± 20.5-19.0 ± 20.2-18.9 ± 15.1
Hour 16-17.0 ± 16.9-17.7 ± 20.0-18.0 ± 16.0-19.8 ± 15.4
Hour 17-17.3 ± 17.3-17.9 ± 20.3-14.7 ± 15.8-19.1 ± 15.5
Hour 18-17.5 ± 18.6-17.4 ± 16.4-15.1 ± 16.8-19.6 ± 16.6
Hour 19-16.5 ± 15.6-19.7 ± 18.4-16.9 ± 15.3-20.9 ± 17.3
Hour 20-17.8 ± 16.4-18.0 ± 17.4-16.5 ± 15.3-24.4 ± 14.3
Hour 21-17.5 ± 15.9-17.8 ± 17.6-15.7 ± 16.4-22.7 ± 15.0
Hour 22-16.2 ± 15.9-15.7 ± 17.0-15.5 ± 18.7-23.8 ± 13.8
Hour 23-14.4 ± 14.6-18.9 ± 16.1-16.5 ± 19.1-22.4 ± 14.0
Hour 24-15.8 ± 14.9-20.7 ± 16.3-18.5 ± 18.1-19.9 ± 13.9
SecondaryChange From Baseline in ABPM 24-hour Mean DBP

Observed results - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM 24-hour Mean DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in ABPM 24-hour Mean DBP-11 ± 7.2-13.2 ± 7.7-12.8 ± 7.4-14.6 ± 6.9
SecondaryChange From Baseline in ABPM 24-hour Mean SBP

Observed results - key combination therapies

Time frame:
End-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM 24-hour Mean SBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in ABPM 24-hour Mean SBP-17.3 ± 10.4-20.5 ± 13.9-19.5 ± 11.6-22.4 ± 9.8
SecondaryOrthostatic Change in Trough Cuff Mean DBP

Calculated as seated minus standing for all patients - key combination therapies

Time frame:
Week 8
Reported as:
Mean · mmHg
Orthostatic Change in Trough Cuff Mean DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Orthostatic Change in Trough Cuff Mean DBP2.2 ± 5.71.7 ± 5.42 ± 5.41.1 ± 4.9
SecondaryOrthostatic Change in Trough Cuff Mean SBP

Calculated as seated minus standing for all patients - key combination therapies

Time frame:
Week 8
Reported as:
Mean · mmHg
Orthostatic Change in Trough Cuff Mean SBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Orthostatic Change in Trough Cuff Mean SBP0 ± 7.50.6 ± 80.9 ± 7.50.8 ± 7.3
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)

Observed results

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
mmHgTelmisartan 0 mg (T0)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)-13.1 ± 9-16.8 ± 8-16.9 ± 8.9-17.7 ± 8.8
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
mmHgPlacebo (Pl)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)-12.7 ± 0.5-17.3 ± 0.7-17.3 ± 0.5-18 ± 0.5
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

Observed results

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
mmHgAmlodipine 0 mg (A0) - OverallAmlodipine 2.5 mg (A2.5) - OverallAmlodipine 5 mg (A5) - OverallAmlodipine 10 mg (A10) - Overall
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)-12.7 ± 10.1-16 ± 8.4-16.3 ± 8.3-19.2 ± 7.8
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
mmHgAmlodipine 0 mg (A0) - OverallAmlodipine 2.5 mg (A2.5) - OverallAmlodipine 5 mg (A5) - OverallAmlodipine 10 mg (A10) - Overall
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)-12.5 ± 0.5-16.4 ± 0.7-16.7 ± 0.5-19.7 ± 0.5
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

Observed results

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)-5.5 ± 10.1-13.9 ± 9.4-13.8 ± 10.2-13.9 ± 9.2-18.4 ± 7.9-15.8 ± 6.4-19.5 ± 7.2-18.7 ± 7.9-16.8 ± 7.5-19.6 ± 8.3-16.3 ± 7.7-18.8 ± 9-20.4 ± 7.3-11.4 ± 8.3-13.1 ± 8.1-17.1 ± 7.6
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)-5.8 ± 1.4-14.4 ± 1.4-14.2 ± 0.8-14.1 ± 0.9-18.9 ± 1.4-15.9 ± 1.4-19.7 ± 1.6-18.8 ± 1.5-17.2 ± 0.8-20.1 ± 0.8-16.6 ± 1.4-19.1 ± 0.8-21 ± 0.8-11.7 ± 1.4-13.3 ± 0.8-17.6 ± 0.9
PrimaryChange From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
mmHgTelmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)-14.5 ± 1.4-14.2 ± 0.8-14.1 ± 0.9-18.9 ± 1.4-15.9 ± 1.4-19.7 ± 1.5-18.8 ± 1.5-17.2 ± 0.8-20.1 ± 0.8-16.6 ± 1.4-19.1 ± 0.8-21 ± 0.8-11.7 ± 1.3-13.3 ± 0.8-17.6 ± 0.9
SecondaryChange From Baseline in Seated Trough Pulse Rate

Observed results for all patients - key combination therapies

Time frame:
End-of-study visit (LOCF)
Reported as:
Mean · bpm
Change From Baseline in Seated Trough Pulse Rate
bpmTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in Seated Trough Pulse Rate0 ± 8.80 ± 9.52.4 ± 9.3-1.5 ± 9.7
SecondaryChange From Baseline in Seated Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Seated Trough Cuff Mean SBP
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Seated Trough Cuff Mean SBP-1.9 ± 2.1-15.6 ± 2.1-15.4 ± 1.2-15.4 ± 1.3-19 ± 2.1-22.1 ± 2.1-25.2 ± 2.3-23.2 ± 2.2-22.2 ± 1.2-25.3 ± 1.3-17.4 ± 2-22.5 ± 1.2-26.5 ± 1.2-12.4 ± 2-14.8 ± 1.2-21 ± 1.4
SecondaryChange From Baseline in Standing Trough Cuff Mean DBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Standing Trough Cuff Mean DBP
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Standing Trough Cuff Mean DBP-4.2 ± 1.4-11.7 ± 1.5-10.9 ± 0.9-11.3 ± 0.9-15.1 ± 1.4-13.3 ± 1.4-17.6 ± 1.6-17.5 ± 1.5-14.2 ± 0.8-18 ± 0.9-14.5 ± 1.4-17.3 ± 0.8-19.2 ± 0.8-8 ± 1.4-11 ± 0.8-15.5 ± 0.9
Other pre-specifiedChange From Baseline in Seated Trough Cuff DBP

Observed results for mod-sev patients - key combination therapies

Time frame:
Nominal week over the trial
Reported as:
Mean · mmHg
Change From Baseline in Seated Trough Cuff DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Week 2-14.7 ± 8.9-14.7 ± 7.8-16.1 ± 7.9-14.9 ± 6.7
Week 4 (N=102, 90, 102, 96)-16.5 ± 6.8-18.2 ± 9.2-17.8 ± 7.6-19.2 ± 6.8
Week 6 (N=102, 92, 98, 96)-17.9 ± 7.8-19.7 ± 8.7-18.9 ± 8.2-19.5 ± 8.4
Week 8 (N=102, 87, 99, 88)-17.1 ± 7.4-19.4 ± 8.5-19.3 ± 8.7-21.1 ± 7.1
SecondaryChange From Baseline in Standing Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Least squares mean · mmHg
Change From Baseline in Standing Trough Cuff Mean SBP
mmHgPlacebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Change From Baseline in Standing Trough Cuff Mean SBP1 ± 2.1-13.7 ± 2.1-13.6 ± 1.2-14 ± 1.3-16.2 ± 2.1-19.4 ± 2.1-23.2 ± 2.3-21.8 ± 2.2-20.4 ± 1.2-22.8 ± 1.3-16.3 ± 2-21.9 ± 1.2-24.3 ± 1.2-10.1 ± 2.1-13.2 ± 1.2-19.3 ± 1.4
SecondaryDBP Control

DBP control is defined as DBP \< 90 mmHg - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Number · percentage of participants
DBP Control
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
DBP Control69.477.168.985
SecondaryDBP Response

DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Number · percentage of participants
DBP Response
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
DBP Response81.589.687.793
Other pre-specifiedBP Control

Responders SBP\<10 mmHg and DBP\<90 mmHg) for mod-sev patients - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Number · percentage of participants
BP Control
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
BP Control53.770.858.577
SecondarySBP Response

SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Number · percentage of participants
SBP Response
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
SBP Response88.996.984.995
SecondaryBP Normality

No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Number · percentage of participants
BP Normality
percentage of participantsTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
No (SBP>=140 and/or DBP>=90)46.329.241.523
High Normal (140>SBP>=130 and 90>DBP>=85)25.929.226.427
Normal (130>SBP>=120 and 85>DBP>=80)18.530.221.741
Optimal (SBP<120 and DBP<80)9.311.510.49
SecondaryChange From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

Observed results for mod-sev patients - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Hour 1-11 ± 10.8-16.9 ± 10.8-13.8 ± 10.1-13.7 ± 10.3
Hour 2-8.8 ± 12.3-16.3 ± 12.5-13.9 ± 9.3-15.9 ± 13
Hour 3-11.2 ± 14.4-13.8 ± 11.2-16.4 ± 11.3-16.1 ± 11.7
Hour 4-10.7 ± 12.4-16.3 ± 13.6-15.9 ± 11.8-16.8 ± 11.3
Hour 5-12.8 ± 10.5-15.3 ± 14.3-17.2 ± 14.3-16.6 ± 10.9
Hour 6-10.5 ± 12.2-15.3 ± 12.6-15.2 ± 10.1-16.3 ± 11.8
Hour 7-13.8 ± 11.1-15.3 ± 11.4-12.9 ± 10.9-17.5 ± 14.6
Hour 8-13.3 ± 13.1-19.4 ± 13.7-13.5 ± 14.2-17.8 ± 13.7
Hour 9-14 ± 11-16.6 ± 14.2-15.8 ± 14.3-18.1 ± 14.1
Hour 10-10.7 ± 11.1-14.6 ± 14-17 ± 14.2-20.8 ± 13.2
Hour 11-11.4 ± 13.9-14.8 ± 12.6-16.8 ± 10.5-17.9 ± 12.9
Hour 12-12.4 ± 12.2-13.9 ± 12.4-14.3 ± 12.2-16.6 ± 12.9
Hour 13-9.7 ± 13-14.9 ± 14.5-14.1 ± 12.5-15.9 ± 10.9
Hour 14-8.5 ± 14.3-14.5 ± 14.6-15.1 ± 11.2-12 ± 14.6
Hour 15-10.5 ± 16.6-10.5 ± 13.6-13.8 ± 14.7-10 ± 12.9
Hour 16-10.9 ± 15-10.3 ± 16.3-12.8 ± 12.2-13.7 ± 13
Hour 17-10.1 ± 14.1-9.8 ± 14.9-11.5 ± 12.5-12.3 ± 10.8
Hour 18-11.8 ± 15.6-9.9 ± 13.5-10.6 ± 10.3-12.8 ± 10.8
Hour 19-9 ± 11.7-11.6 ± 13.9-12.2 ± 10.6-12.5 ± 11.8
Hour 20-10 ± 12.3-10.9 ± 13.1-13.3 ± 11.2-15.7 ± 11.5
Hour 21-10.5 ± 12.3-8.6 ± 14.3-8.4 ± 12.1-15.1 ± 9.4
Hour 22-10.9 ± 11.3-10 ± 14.6-10.2 ± 13.5-15.2 ± 10.2
Hour 23-10 ± 11.8-14 ± 13.8-10 ± 12.5-14.3 ± 8.5
Hour 24-9.7 ± 9.8-13.6 ± 11.2-13.2 ± 13.8-14.4 ± 12.2
SecondaryChange From Baseline in ABPM 24-hour Mean DBP

Observed results for mod-sev patients - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM 24-hour Mean DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in ABPM 24-hour Mean DBP-11 ± 7.7-13.6 ± 8-13.6 ± 7.1-15.3 ± 7
SecondaryChange From Baseline in ABPM 24-hour Mean SBP

Observed results for mod-sev patients - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · mmHg
Change From Baseline in ABPM 24-hour Mean SBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in ABPM 24-hour Mean SBP-16.7 ± 11.3-20.8 ± 14.1-20.9 ± 11-22.7 ± 9.9
SecondaryOrthostatic Change in Trough Cuff Mean DBP

Calculated as seated minus standing for mod-sev patients - key combination therapies

Time frame:
Week 8
Reported as:
Mean · mmHg
Orthostatic Change in Trough Cuff Mean DBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Orthostatic Change in Trough Cuff Mean DBP2.5 ± 5.12 ± 5.71.4 ± 5.31.6 ± 4.5
SecondaryOrthostatic Change in Trough Cuff Mean SBP

Calculated as seated minus standing for mod-sev patients - key combination therapies

Time frame:
Week 8
Reported as:
Mean · mmHg
Orthostatic Change in Trough Cuff Mean SBP
mmHgTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Orthostatic Change in Trough Cuff Mean SBP0 ± 7.11.4 ± 8.10.1 ± 6.91.1 ± 6.3
SecondaryChange From Baseline in Seated Trough Pulse Rate

Observed results for mod-sev patients - key combination therapies

Time frame:
Up to 8 weeks (LOCF)
Reported as:
Mean · bpm
Change From Baseline in Seated Trough Pulse Rate
bpmTelmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Change From Baseline in Seated Trough Pulse Rate0.5 ± 8.80 ± 92.5 ± 9.2-1.9 ± 8.9
SecondaryClinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)

Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).

Time frame:
8 weeks
Reported as:
Number · percentage of participants
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
percentage of participantsPlacebo (Pl)Telmisartan MonotherapyAmlodipine MonotherapyCombination Therapy
Alanine aminotransferase increased0.00.30.00.1
Aspartate aminotransferase increased0.00.30.00.1
Blood potassium increased0.00.30.00.0
Electrocardiogram QT shortened0.00.00.30.0
Electrocardiogram T wave abnormal0.00.00.30.1
Electrocardiogram repolarisation abnormality0.00.00.00.1
Heart rate irregular0.00.00.30.0
QRS axis abnormal0.00.00.30.0
Atrioventricular block first degree0.00.00.00.3
Left atrial dilatation0.00.00.00.1
Myocardial ischaemia0.00.10.00.0
Palpitation0.00.00.60.1
Sinus bradycardia0.00.00.00.1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PLACEBO—0/46 (0%)—
Telmisartan 20 mg (T20)—0/42 (0%)—
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)—0/44 (0%)—
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)—0/46 (0%)—
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)—0/44 (0%)—
Telmisartan 40 mg (T40)—0/130 (0%)—
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)—0/47 (0%)—
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)—0/143 (0%)—
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)—0/129 (0%)—
Telmisartan 80 mg (T80)—1/135 (0.7%)—
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)—2/48 (4.2%)—
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)—2/146 (1.4%)—
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)—0/142 (0%)—
Amlodipine 2.5 mg (A2.5)—1/50 (2%)—
Amlodipine 5 mg (A5)—1/140 (0.7%)—
Amlodipine 10 mg (A10)—0/129 (0%)—
Most frequent serious events
Most frequent serious events
EventPLACEBOTelmisartan 20 mg (T20)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg (T40)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg (T80)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Chest painGeneral disorders0/460/420/440/460/440/1300/470/1430/1290/1351/481/1460/1420/500/1400/129
SinusitisInfections and infestations0/460/420/440/460/440/1300/470/1430/1290/1351/480/1460/1420/500/1400/129
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/460/420/440/460/440/1300/470/1430/1290/1350/480/1460/1421/500/1400/129
ChokingRespiratory, thoracic and mediastinal disorders0/460/420/440/460/440/1300/470/1430/1291/1350/480/1460/1420/500/1400/129
DiverticulitisInfections and infestations0/460/420/440/460/440/1300/470/1430/1290/1350/480/1460/1420/501/1400/129
Deep vein thrombosisVascular disorders0/460/420/440/460/440/1300/470/1430/1290/1350/481/1460/1420/500/1400/129
Most frequent other events
Most frequent other events
EventPLACEBOTelmisartan 20 mg (T20)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg (T40)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg (T80)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)
Oedema peripheralGeneral disorders0/460/421/442/465/441/1300/472/1437/1291/1351/483/14616/1421/501/14023/129
HeadacheNervous system disorders5/463/423/444/462/4411/1303/477/1435/1294/1350/486/1467/1422/509/1407/129
Chest painGeneral disorders1/463/420/440/460/442/1300/471/1431/1290/1350/481/1460/1420/500/1401/129

Baseline characteristics

Treated set including all 1461 patients who were randomised to receive double-blind treatment and took at least one dose.

Age, Continuous
Age, Continuous(Years)Placebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)Total
Mean52.5 ± 12.353.6 ± 10.452 ± 1153.1 ± 11.354 ± 10.854.4 ± 10.251 ± 11.250.7 ± 10.252.3 ± 11.953.3 ± 11.354.8 ± 9.752.7 ± 11.953.9 ± 11.655.3 ± 10.453.1 ± 10.653.4 ± 10.753.1 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Placebo (Pl)Telmisartan 20 mg (T20)Telmisartan 40 mg (T40)Telmisartan 80 mg (T80)Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)Amlodipine 2.5 mg (A2.5)Amlodipine 5 mg (A5)Amlodipine 10 mg (A10)Total
Female17166475182518217267267278236864724
Male29266660262126267162227464277265737
08

Study locations

136 sites
  • 1235.1.457 Boehringer Ingelheim Investigational Site
    Fairhope, Alabama, United States
  • 1235.1.368 Boehringer Ingelheim Investigational Site
    Huntsville, Alabama, United States
  • 1235.1.389 Boehringer Ingelheim Investigational Site
    Huntsville, Alabama, United States
  • 1235.1.411 Boehringer Ingelheim Investigational Site
    Huntsville, Alabama, United States
  • 1235.1.429 Boehringer Ingelheim Investigational Site
    Chandler, Arizona, United States
  • 1235.1.420 Boehringer Ingelheim Investigational Site
    Tempe, Arizona, United States
  • 1235.1.391 Boehringer Ingelheim Investigational Site
    Cudahy, California, United States
  • 1235.1.444 Boehringer Ingelheim Investigational Site
    Encinitas, California, United States
  • 1235.1.445 Boehringer Ingelheim Investigational Site
    Encino, California, United States
  • 1235.1.357 Boehringer Ingelheim Investigational Site
    Long Beach, California, United States
  • 1235.1.465 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
  • 1235.1.441 Boehringer Ingelheim Investigational Site
    Riverside, California, United States
  • 1235.1.409 Boehringer Ingelheim Investigational Site
    Sacramento, California, United States
  • 1235.1.406 Boehringer Ingelheim Investigational Site
    San Diego, California, United States
  • 1235.1.414 Boehringer Ingelheim Investigational Site
    Santa Ana, California, United States
  • 1235.1.383 Boehringer Ingelheim Investigational Site
    Spring Valley, California, United States
  • 1235.1.395 Boehringer Ingelheim Investigational Site
    Tustin, California, United States
  • 1235.1.453 Boehringer Ingelheim Investigational Site
    Milford, Connecticut, United States
  • 1235.1.394 Boehringer Ingelheim Investigational Site
    Newark, Delaware, United States
  • 1235.1.354 Boehringer Ingelheim Investigational Site
    Cooper City, Florida, United States
  • 1235.1.451 Boehringer Ingelheim Investigational Site
    Deland, Florida, United States
  • 1235.1.372 Boehringer Ingelheim Investigational Site
    Fort Lauderdale, Florida, United States
  • 1235.1.396 Boehringer Ingelheim Investigational Site
    Fort Lauderdale, Florida, United States
  • 1235.1.390 Boehringer Ingelheim Investigational Site
    Hialeah, Florida, United States
  • 1235.1.430 Boehringer Ingelheim Investigational Site
    Kissimmee, Florida, United States
  • 1235.1.351 Boehringer Ingelheim Investigational Site
    Melbourne, Florida, United States
  • 1235.1.398 Boehringer Ingelheim Investigational Site
    Melbourne, Florida, United States
  • 1235.1.405 Boehringer Ingelheim Investigational Site
    Mirimar, Florida, United States
  • 1235.1.352 Boehringer Ingelheim Investigational Site
    Pembroke Pines, Florida, United States
  • 1235.1.369 Boehringer Ingelheim Investigational Site
    Pembroke Pines, Florida, United States
  • 1235.1.397 Boehringer Ingelheim Investigational Site
    Pembroke Pines, Florida, United States
  • 1235.1.449 Boehringer Ingelheim Investigational Site
    Pensacola, Florida, United States
  • 1235.1.355 Boehringer Ingelheim Investigational Site
    Rockledge, Florida, United States
  • 1235.1.407 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
  • 1235.1.380 Boehringer Ingelheim Investigational Site
    Tucker, Georgia, United States
  • 1235.1.438 Boehringer Ingelheim Investigational Site
    Gurnee, Illinois, United States
  • 1235.1.373 Boehringer Ingelheim Investigational Site
    Evansville, Indiana, United States
  • 1235.1.375 Boehringer Ingelheim Investigational Site
    Evansville, Indiana, United States
  • 1235.1.415 Boehringer Ingelheim Investigational Site
    Indianapolis, Indiana, United States
  • 1235.1.412 Boehringer Ingelheim Investigational Site
    South Bend, Indiana, United States
  • 1235.1.435 Boehringer Ingelheim Investigational Site
    Arkansas City, Kansas, United States
  • 1235.1.379 Boehringer Ingelheim Investigational Site
    Lenexa, Kansas, United States
  • 1235.1.421 Boehringer Ingelheim Investigational Site
    Newtown, Kansas, United States
  • 1235.1.356 Boehringer Ingelheim Investigational Site
    Wichita, Kansas, United States
  • 1235.1.423 Boehringer Ingelheim Investigational Site
    Louisville, Kentucky, United States
  • 1235.1.387 Boehringer Ingelheim Investigational Site
    North Dartmouth, Massachusetts, United States
  • 1235.1.424 Boehringer Ingelheim Investigational Site
    Bay City, Michigan, United States
  • 1235.1.385 Boehringer Ingelheim Investigational Site
    Florissant, Missouri, United States
  • 1235.1.452 Boehringer Ingelheim Investigational Site
    Florissant, Missouri, United States
  • 1235.1.365 Boehringer Ingelheim Investigational Site
    Kansas City, Missouri, United States
  • 1235.1.431 Boehringer Ingelheim Investigational Site
    Kansas City, Missouri, United States
  • 1235.1.454 Boehringer Ingelheim Investigational Site
    Henderson, Nevada, United States
  • 1235.1.426 Boehringer Ingelheim Investigational Site
    Cherry Hill, New Jersey, United States
  • 1235.1.434 Boehringer Ingelheim Investigational Site
    Stratford, New Jersey, United States
  • 1235.1.366 Boehringer Ingelheim Investigational Site
    East Syracuse, New York, United States
  • 1235.1.377 Boehringer Ingelheim Investigational Site
    Northport, New York, United States
  • 1235.1.427 Boehringer Ingelheim Investigational Site
    Rochester, New York, United States
  • 1235.1.381 Boehringer Ingelheim Investigational Site
    Williamsville, New York, United States
  • 1235.1.410 Boehringer Ingelheim Investigational Site
    Burlington, North Carolina, United States
  • 1235.1.400 Boehringer Ingelheim Investigational Site
    Charlotte, North Carolina, United States
  • 1235.1.422 Boehringer Ingelheim Investigational Site
    Greenboro, North Carolina, United States
  • 1235.1.403 Boehringer Ingelheim Investigational Site
    Lenior, North Carolina, United States
  • 1235.1.376 Boehringer Ingelheim Investigational Site
    Raleigh, North Carolina, United States
  • 1235.1.392 Boehringer Ingelheim Investigational Site
    Raleigh, North Carolina, United States
  • 1235.1.384 Boehringer Ingelheim Investigational Site
    Winston-Salem, North Carolina, United States
  • 1235.1.458 Boehringer Ingelheim Investigational Site
    Winston-Salem, North Carolina, United States
  • 1235.1.374 Boehringer Ingelheim Investigational Site
    Columbus, Ohio, United States
  • 1235.1.446 Boehringer Ingelheim Investigational Site
    Columbus, Ohio, United States
  • 1235.1.413 Boehringer Ingelheim Investigational Site
    Marion, Ohio, United States
  • 1235.1.359 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
  • 1235.1.361 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
  • 1235.1.436 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
  • 1235.1.448 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
  • 1235.1.386 Boehringer Ingelheim Investigational Site
    Tulsa, Oklahoma, United States
  • 1235.1.439 Boehringer Ingelheim Investigational Site
    Portland, Oregon, United States
  • 1235.1.440 Boehringer Ingelheim Investigational Site
    Portland, Oregon, United States
  • 1235.1.408 Boehringer Ingelheim Investigational Site
    Erie, Pennsylvania, United States
  • 1235.1.404 Boehringer Ingelheim Investigational Site
    Lansdale, Pennsylvania, United States
  • 1235.1.428 Boehringer Ingelheim Investigational Site
    Penndel, Pennsylvania, United States
  • 1235.1.370 Boehringer Ingelheim Investigational Site
    East Providence, Rhode Island, United States
  • 1235.1.433 Boehringer Ingelheim Investigational Site
    Beaufort, South Carolina, United States
  • 1235.1.462 Boehringer Ingelheim Investigational Site
    Union, South Carolina, United States
  • 1235.1.417 Boehringer Ingelheim Investigational Site
    Cordova, Tennessee, United States
  • 1235.1.459 Boehringer Ingelheim Investigational Site
    Jackson, Tennessee, United States
  • 1235.1.363 Boehringer Ingelheim Investigational Site
    New Tazewell, Tennessee, United States
  • 1235.1.382 Boehringer Ingelheim Investigational Site
    Selmer, Tennessee, United States
  • 1235.1.442 Boehringer Ingelheim Investigational Site
    Austin, Texas, United States
  • 1235.1.399 Boehringer Ingelheim Investigational Site
    Carrollton, Texas, United States
  • 1235.1.460 Boehringer Ingelheim Investigational Site
    Dallas, Texas, United States
  • 1235.1.443 Boehringer Ingelheim Investigational Site
    Georgetown, Texas, United States
  • 1235.1.416 Boehringer Ingelheim Investigational Site
    Killeen, Texas, United States
  • 1235.1.402 Boehringer Ingelheim Investigational Site
    Lake Jackson, Texas, United States
  • 1235.1.432 Boehringer Ingelheim Investigational Site
    McKinney, Texas, United States
  • 1235.1.456 Boehringer Ingelheim Investigational Site
    Odessa, Texas, United States
  • 1235.1.418 Boehringer Ingelheim Investigational Site
    Plano, Texas, United States
  • 1235.1.455 Boehringer Ingelheim Investigational Site
    Waco, Texas, United States
  • 1235.1.358 Boehringer Ingelheim Investigational Site
    Salt Lake City, Utah, United States
  • 1235.1.464 Boehringer Ingelheim Investigational Site
    Salt Lake City, Utah, United States
  • 1235.1.437 Boehringer Ingelheim Investigational Site
    Burke, Virginia, United States
  • 1235.1.447 Boehringer Ingelheim Investigational Site
    Fredericksburg, Virginia, United States

Showing the first 100 of 136 sites across 5 countries.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00281580
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jan 25, 2006
Start date
Apr 2006
Primary completion
Mar 2007
Results posted
Apr 28, 2010
Last update
Mar 27, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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