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CompletedNCT00654745Updated Jul 13, 2010Results posted

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

A Phase 4 interventional study of Amlodipine and amlodipine / olmesartan medoxomil combination in Type 2 Diabetes and Hypertension, sponsored by Daiichi Sankyo. Completed at 21 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-07-13.

Sponsored by Daiichi Sankyo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
207
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Read the detailed description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

02

Conditions studied

  • Type 2 Diabetes
  • Hypertension

Browse trials for

Keywords

  • blood pressure reduction
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 207 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males or females aged 18 to 80 years.
  • Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);

Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:

  • Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or
  • Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or
  • Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;
  • Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.
  • Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.
  • Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Exclusion criteria

Exclusion Criteria:

  • Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
  • Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;
  • Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
  • Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
207 participants (actual)

Study arms

  • Experimental
    aml + olm + hctz

    amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.

    Drug: Amlodipine · Drug: amlodipine / olmesartan medoxomil combination · Drug: Hydrochlorothiazide

Interventions

  • DrugAmlodipine

    Amlodipine 5 mg tablets , Daily for 3 weeks;

    Also known as: Norvasc

  • Drugamlodipine / olmesartan medoxomil combination

    amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg

    Also known as: Azor

  • DrugHydrochlorothiazide

    hydrochlorothiazide tablets, 12.5 mg or 25 mg.

06

What researchers measure

Primary outcomes

  1. Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

    Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

    Time frame: week 0 - week 12

Secondary outcomes

  1. Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

    24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP

    Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

  2. Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

    Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP

    Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

  3. Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

    change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

    Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

  4. Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

    change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

    Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

  5. Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

    number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  6. Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

    number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  7. Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

    number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12

    Time frame: week 0 - week 12

  8. Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

    number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  9. Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

    number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  10. Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

    number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  11. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3

    Time frame: week 0 - week 3

  12. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 6

    Time frame: week 0 - week 6

  13. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 9

    Time frame: week 0 - week 9

  14. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

    Time frame: week 0 - week 12

  15. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 15

    Time frame: week 0 - week 15

  16. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 18

    Time frame: week 0 - week 18

  17. Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  18. Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  19. Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  20. Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  21. Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

    number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  22. Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  23. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3

    Time frame: week 0 - week 3

  24. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 6

    Time frame: week 0 - week 6

  25. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 9

    Time frame: week 0 - week 9

  26. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

    Time frame: week 0 - week 12

  27. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 15

    Time frame: week 0 - week 15

  28. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 18

    Time frame: week 0 - week 18

07

Results

Posted Jul 2, 2010

Participant flow

Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.

Participant flow — Overall Study
MilestoneAmlodipine, Olmesartan Medoxomil, Hydrochlorothiazide
Started207
Completed164
Not completed43
Withdrew: Adverse event12
Withdrew: Lost to follow-up7
Withdrew: Protocol violation11
Withdrew: Withdrawal by subject10
Withdrew: Poor abpm, noncompliance, lab mas3

Outcome measures

PrimaryChange From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Time frame:
week 0 - week 12
Reported as:
Mean · mm Hg
Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
mm HgAml + Olm + Hctz
Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment-19.9 ± 0.76
Statistical analysis
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 · Mean difference (net): -19.9 · 95% CI -21.5 to -18.4
SecondaryChange From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP

Time frame:
week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Reported as:
Mean · mm Hg
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
mm HgAml + Olm + Hctz
24-hour mean DBP change from baseline-11.2 ± 0.50
daytime mean DBP change from baseline-11.7 ± 0.60
nighttime mean DBP change from baseline-10.4 ± 0.68
last 6 hour mean DBP change from baseline-10.9 ± 0.64
last 4 hour mean DBP change from baseline-11.1 ± 0.68
last 2 hour mean DBP change from baseline-11.5 ± 0.76
Statistical analysis
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (24-hour mean DBP change from baseline to week 12.) · Mean difference (net): -11.2 · 95% CI -12.2 to -10.3standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (daytime mean DBP change from baseline to week 12.) · Mean difference (net): -11.7 · 95% CI -12.9 to -10.5standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (nighttime mean DBP change from baseline to week 12.) · Mean difference (net): -10.4 · 95% CI -11.7 to -9.0standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 6 hours mean DBP change from baseline to week 12.) · Mean difference (net): -10.9 · 95% CI -12.2 to -9.7standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 4 hours mean DBP change from baseline to week 12.) · Mean difference (net): -11.1 · 95% CI -12.4 to -9.8standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 2 hours mean DBP change from baseline to week 12.) · Mean difference (net): -11.5 · 95% CI -13.1 to -10.0standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
SecondaryChange From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP

Time frame:
week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Reported as:
Mean · mm Hg
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
mm HgAml + Olm + Hctz
daytime mean SBP change from baseline-20.8 ± 0.92
nighttime mean SBP change from baseline-18.5 ± 0.95
last 6 hours mean SBP change from baseline-18.9 ± 0.93
last 4 hours mean SBP change from baseline-19.1 ± 1.02
last 2 hours mean SBP change from baseline-19.5 ± 1.10
Statistical analysis
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (daytime mean SBP change from baseline to week 12.) · Mean difference (net): -20.8 · 95% CI -22.6 to -18.9standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (nighttime mean SBP change from baseline to week 12.) · Mean difference (net): -18.5 · 95% CI -20.4 to -16.6standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 6 hours mean SBP change from baseline to week 12.) · Mean difference (net): -18.9 · 95% CI -20.7 to -17.0standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 4 hours mean SBP change from baseline to week 12.) · Mean difference (net): -19.1 · 95% CI -21.1 to -17.1standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (last 2 hours mean SBP change from baseline to week 12.) · Mean difference (net): -19.5 · 95% CI -21.7 to -17.4standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
SecondaryChange in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame:
week 0 - weeks 3, 6, 9, 12, 15, 18
Reported as:
Mean · mm Hg
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
mm HgAml + Olm + Hctz
week 3 mean SBP change from baseline-10.3 ± 0.87
week 6 mean SBP change from baseline-17.9 ± 0.92
week 9 mean SBP change from baseline-20.0 ± 1.10
week 12 mean SBP change from baseline-23.7 ± 1.02
week 15 mean SBP change from baseline-28.5 ± 1.16
week 18 mean SBP change from baseline-31.1 ± 1.13
Statistical analysis
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 3.) · Mean difference (net): -10.3 · 95% CI -12.0 to -8.6standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 6.) · Mean difference (net): -17.9 · 95% CI -19.8 to -16.1standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 9) · Mean difference (net): -20.0 · 95% CI -22.2 to -17.8standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 12) · Mean difference (net): -23.7 · 95% CI -25.7 to -21.7standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 15) · Mean difference (net): -28.5 · 95% CI -30.8 to -26.2standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated systolic blood pressure from baseline to week 18) · Mean difference (net): -31.1 · 95% CI -33.3 to -28.8standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
SecondaryChange in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame:
week 0 - weeks 3, 6, 9, 12, 15, 18
Reported as:
Mean · mm Hg
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
mm HgAml + Olm + Hctz
week 3 mean seDBP change from baseline-4.1 ± 0.50
week 6 mean seDBP change from baseline-8.2 ± 0.60
week 9 mean seDBP change from baseline-9.7 ± 0.64
week 12 mean seDBP change from baseline-11.2 ± 0.64
week 15 mean seDBP change from baseline-14.4 ± 0.66
week 18 mean seDBP change from baseline-15.1 ± 0.72
Statistical analysis
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 3.) · Mean difference (net): -4.1 · 95% CI -5.1 to -3.1standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 6) · Mean difference (net): -8.2 · 95% CI -9.4 to -7.1standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 9) · Mean difference (net): -9.7 · 95% CI -10.9 to -8.4standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 12) · Mean difference (net): -11.2 · 95% CI -12.5 to -9.9standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 15) · Mean difference (net): -14.4 · 95% CI -15.7 to -13.1standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
  • Aml + Olm + Hctz · t-test, 2 sided · p = <0.0001 (Change in mean seated diastolic blood pressure from baseline to week 18) · Mean difference (net): -15.1 · 95% CI -16.5 to -13.6standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
SecondaryNumber of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean 24-hour BP <135/85140
mean 24-hour BP <130/80116
mean 24-hour BP <125/7576
mean 24-hour BP <120/8059
mean 24-hour SBP <135140
mean 24-hour SBP <130120
mean 24-hour SBP <12592
mean 24-hour SBP <12059
mean 24-hour DBP <85158
mean 24-hour DBP <80146
mean 24-hour DBP <75121
SecondaryNumber of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean daytime BP < 135/85116
mean daytime BP < 130/8083
mean daytime BP < 125/7548
mean daytime BP < 120/8042
mean daytime SBP < 135118
mean daytime SBP < 13094
mean daytime SBP < 12567
mean daytime SBP < 12042
mean daytime DBP < 85151
mean daytime DBP < 80124
mean daytime DBP < 7591
SecondaryNumber of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean nighttime BP < 135/85152
mean nighttime BP < 130/80137
mean nighttime BP < 125/75119
mean nighttime BP < 120/80112
mean nighttime BP < 120/70101
mean nighttime SBP < 135154
mean nighttime SBP < 130139
mean nighttime SBP < 125123
mean nighttime SBP < 120112
mean nighttime DBP < 85160
mean nighttime DBP < 80158
mean nighttime DBP < 75147
mean nighttime DBP < 70124
SecondaryNumber of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean last 6 hour BP < 135/85135
mean last 6 hour BP < 130/80124
mean last 6 hour BP < 125/75101
mean last 6 hour BP < 120/8085
mean last 6 hour SBP < 135143
mean last 6 hour SBP < 130127
mean last 6 hour SBP < 125108
mean last 6 hour SBP < 12085
mean last 6 hour DBP < 85157
mean last 6 hour DBP < 80146
mean last 6 hour DBP < 75130
SecondaryNumber of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean last 4 hour BP < 135/85129
mean last 4 hour BP < 130/80107
mean last 4 hour BP < 125/7592
mean last 4 hour BP < 120/8072
mean last 4 hour SBP < 135131
mean last 4 hour SBP < 130114
mean last 4 hour SBP < 125102
mean last 4 hour SBP < 12072
mean last 4 hour DBP < 85150
mean last 4 hour DBP < 80137
mean last 4 hour DBP < 75120
SecondaryNumber of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean last 2 hour BP < 135/85110
mean last 2 hour BP < 130/8085
mean last 2 hour BP < 125/7563
mean last 2 hour BP < 120/8049
mean last 2 hour SBP < 135115
mean last 2 hour SBP < 13092
mean last 2 hour SBP < 12576
mean last 2 hour SBP < 12051
mean last 2 hour DBP < 85145
mean last 2 hour DBP < 80125
mean last 2 hour DBP < 7594
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3

Time frame:
week 0 - week 3
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
participantsAml + Olm + Hctz
mean BP < 135/8531
mean BP < 130/8010
mean BP < 125/754
mean BP < 120/802
mean SBP < 13541
mean SBP < 13017
mean SBP < 1259
mean SBP < 1202
mean DBP < 8599
mean DBP < 8058
mean DBP < 7529
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 6

Time frame:
week 0 - week 6
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
participantsAml + Olm + Hctz
mean BP < 135/8561
mean BP < 130/8036
mean BP < 125/7518
mean BP < 120/8013
mean SBP < 13573
mean SBP < 13048
mean SBP < 12531
mean SBP < 12014
mean DBP < 85127
mean DBP < 8091
mean DBP < 7548
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 9

Time frame:
week 0 - week 9
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
participantsAml + Olm + Hctz
mean BP < 135/8576
mean BP < 130/8047
mean BP < 125/7525
mean BP < 120/8019
mean SBP < 13582
mean SBP < 13061
mean SBP < 12541
mean SBP < 12020
mean DBP < 85132
mean DBP < 8095
mean DBP < 7564
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
participantsAml + Olm + Hctz
mean BP < 135/8586
mean BP < 130/8061
mean BP < 125/7533
mean BP < 120/8028
mean SBP < 13593
mean SBP < 13070
mean SBP < 12546
mean SBP < 12028
mean DBP < 85134
mean DBP < 80105
mean DBP < 7574
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 15

Time frame:
week 0 - week 15
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
participantsAml + Olm + Hctz
mean BP < 135/85114
mean BP < 130/8083
mean BP < 125/7551
mean BP < 120/8045
mean SBP < 135116
mean SBP < 13095
mean SBP < 12569
mean SBP < 12048
mean DBP < 85153
mean DBP < 80122
mean DBP < 7596
SecondaryNumber of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 18

Time frame:
week 0 - week 18
Reported as:
Number · participants
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
participantsAml + Olm + Hctz
mean BP < 135/85117
mean BP < 130/8087
mean BP < 125/7556
mean BP < 120/8049
mean SBP < 135123
mean SBP < 130101
mean SBP < 12574
mean SBP < 12051
mean DBP < 85147
mean DBP < 80128
mean DBP < 7594
SecondaryNumber of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean 24-hour SBP reduction =<15 mm Hg50
mean 24-hour SBP reduction >15 & =<30 mm Hg91
mean 24-hour SBP reduction >30 & =<45 mm Hg22
mean 24-hour SBP reduction >45 mm Hg2
mean 24-hour DBP reduction =<10 mm Hg72
mean 24-hour DBP reduction >10 & =<15 mm Hg47
mean 24-hour DBP reduction >15 & =<20 mm Hg31
mean 24-hour DBP reduction >20 mm Hg15
SecondaryNumber of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean daytime SBP reduction =<15 mm Hg47
mean daytime SBP reduction >15 & =<30 mm Hg84
mean daytime SBP reduction >30 & =<45 mm Hg31
mean daytime SBP reduction >45 mm Hg3
mean daytime DBP reduction =<10 mm Hg68
mean daytime DBP reduction >10 & =<15 mm Hg41
mean daytime DBP reduction >15 & =<20 mm Hg33
mean daytime DBP reduction >20 mm Hg23
SecondaryNumber of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean nighttime SBP reduction =<15 mm Hg60
mean nighttime SBP reduction >15 & =<30 mm Hg79
mean nighttime SBP reduction >30 & =<45 mm Hg21
mean nighttime SBP reduction >45 mm Hg5
mean nighttime DBP reduction =<10 mm Hg80
mean nighttime SBP reduction >10 & =<15 mm Hg41
mean nighttime SBP reduction >15 & =<20 mm Hg21
mean nighttime DBP reduction >20 mm Hg23
SecondaryNumber of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean last 6 hour SBP reduction =<15 mm Hg61
mean last 6 hour SBP reduction >15 & =<30 mm Hg76
mean last 6 hour SBP reduction >30 & =<45 mm Hg23
mean last 6 hour SBP reduction >45 mm Hg5
mean last 6 hour DBP reduction =<10 mm Hg76
mean last 6 hour DBP reduction >10 & =<15 mm Hg41
mean last 6 hour DBP reduction >15 & =<20 mm Hg27
mean last 6 hour DBP reduction >20 mm Hg21
SecondaryNumber of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
participantsAml + Olm + Hctz
mean last 4 hour SBP reduction =<15 mm Hg67
mean last 4 hour SBP reduction >15 & =<30 mm Hg65
mean last 4 hour SBP reduction >30 & =<45 mm Hg28
mean last 4 hour SBP reduction >45 mm Hg5
mean last 4 hour DBP reduction =<10 mm Hg76
mean last 4 hour DBP reduction >10 & =<15 mm Hg36
mean last 4 hour DBP reduction >15 & =<20 mm Hg25
mean last 4 hour DBP reduction >20 mm Hg28
SecondaryNumber of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean last 2 hour SBP reduction =<15 mm Hg63
mean last 2 hour SBP reduction >15 & =<30 mm Hg62
mean last 2 hour SBP reduction >30 & =<45 mm Hg35
mean last 2 hour SBP reduction >45 mm Hg5
mean last 2 hour DBP reduction =<10 mm Hg77
mean last 2 hour DBP reduction >10 & =<15 mm Hg28
mean last 2 hour DBP reduction >15 & =<20 mm Hg29
mean last 2 hour DBP reduction >20 mm Hg31
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3

Time frame:
week 0 - week 3
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg131
mean seated SBP reduction >15 & =<30 mm Hg62
mean seated SBP reduction >30 & =<45 mm Hg6
mean seated SBP reduction >45 mm Hg2
mean seated DBP reduction =<10 mm Hg163
mean seated DBP reduction >10 & =<15 mm Hg25
mean seated DBP reduction >15 & =<20 mm Hg10
mean seated DBP reduction >20 mm Hg3
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 6

Time frame:
week 0 - week 6
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg69
mean seated SBP reduction >15 & =<30 mm Hg90
mean seated SBP reduction >30 & =<45 mm Hg31
mean seated SBP reduction >45 mm Hg2
mean seated DBP reduction =<10 mm Hg120
mean seated DBP reduction >10 & =<15 mm Hg33
mean seated DBP reduction >15 & =<20 mm Hg24
mean seated DBP reduction >20 mm Hg15
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 9

Time frame:
week 0 - week 9
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg72
mean seated SBP reduction >15 & =<30 mm Hg69
mean seated SBP reduction >30 & =<45 mm Hg34
mean seated SBP reduction >45 mm Hg9
mean seated DBP reduction =<10 mm Hg100
mean seated DBP reduction >10 & =<15 mm Hg43
mean seated DBP reduction >15 & =<20 mm Hg18
mean seated DBP reduction >20 mm Hg23
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame:
week 0 - week 12
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg48
mean seated SBP reduction >15 & =<30 mm Hg73
mean seated SBP reduction >30 & =<45 mm Hg45
mean seated SBP reduction >45 mm Hg11
mean seated DBP reduction =<10 mm Hg85
mean seated DBP reduction >10 & =<15 mm Hg42
mean seated DBP reduction >15 & =<20 mm Hg27
mean seated DBP reduction >20 mm Hg23
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 15

Time frame:
week 0 - week 15
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg31
mean seated SBP reduction >15 & =<30 mm Hg66
mean seated SBP reduction >30 & =<45 mm Hg55
mean seated SBP reduction >45 mm Hg20
mean seated DBP reduction =<10 mm Hg52
mean seated DBP reduction >10 & =<15 mm Hg45
mean seated DBP reduction >15 & =<20 mm Hg32
mean seated DBP reduction >20 mm Hg43
SecondaryNumber of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 18

Time frame:
week 0 - week 18
Reported as:
Number · participants
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
participantsAml + Olm + Hctz
mean seated SBP reduction =<15 mm Hg22
mean seated SBP reduction >15 & =<30 mm Hg53
mean seated SBP reduction >30 & =<45 mm Hg64
mean seated SBP reduction >45 mm Hg25
mean seated DBP reduction =<10 mm Hg50
mean seated DBP reduction >10 & =<15 mm Hg33
mean seated DBP reduction >15 & =<20 mm Hg29
mean seated DBP reduction >20 mm Hg52

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ALL - Aml + Olm + Hctz—4/207 (1.9%)80/207 (38.6%)
Start - Amlodipine 5 mg—0/207 (0%)16/207 (7.7%)
Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg—0/195 (0%)15/195 (7.7%)
Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg—1/177 (0.6%)10/177 (5.6%)
Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg—0/167 (0%)21/167 (12.6%)
Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg—1/146 (0.7%)14/146 (9.6%)
Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg—2/101 (2%)4/101 (4%)
Most frequent serious events
Most frequent serious events
EventALL - Aml + Olm + HctzStart - Amlodipine 5 mgTitration 1 - Amlodipine 5 mg / Olmesartan 20 mgTitration 2 - Amlodipine 5 mg / Olmesartan 40 mgTitration 3 - Amlodipine 10 mg / Olmesartan 40 mgTitration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mgTitration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
pneumoniaInfections and infestations1/2070/2070/1950/1770/1670/1461/101
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/2070/2070/1951/1770/1670/1461/101
hyperkalaemiaMetabolism and nutrition disorders1/2070/2070/1950/1770/1671/1460/101
presyncopeNervous system disorders1/2070/2070/1950/1770/1671/1460/101
Most frequent other events
Most frequent other events
EventALL - Aml + Olm + HctzStart - Amlodipine 5 mgTitration 1 - Amlodipine 5 mg / Olmesartan 20 mgTitration 2 - Amlodipine 5 mg / Olmesartan 40 mgTitration 3 - Amlodipine 10 mg / Olmesartan 40 mgTitration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mgTitration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
oedema peripheralGeneral disorders20/2077/2073/1952/1777/1671/1460/101
dizzinessNervous system disorders12/2073/2071/1952/1771/1675/1460/101
upper respiratory tract infectionInfections and infestations11/2070/2072/1953/1773/1673/1460/101
anaemiaBlood and lymphatic system disorders7/2070/2070/1950/1774/1671/1462/101
headacheNervous system disorders6/2073/2070/1950/1772/1670/1461/101
bronchitisInfections and infestations5/2071/2072/1950/1771/1671/1460/101
pain in extremityMusculoskeletal and connective tissue disorders5/2071/2072/1951/1770/1671/1460/101
arthralgiaMusculoskeletal and connective tissue disorders5/2071/2073/1950/1771/1670/1460/101
coughRespiratory, thoracic and mediastinal disorders5/2070/2071/1952/1772/1670/1460/101
hypotensionVascular disorders4/2070/2071/1950/1770/1672/1461/101

Baseline characteristics

Age Continuous
Age Continuous(years)Aml + Olm + Hctz
Mean59.1 ± 9.50
Sex: Female, Male
Sex: Female, Male(Participants)Aml + Olm + Hctz
Female122
Male85
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Aml + Olm + Hctz
Hispanic or Latino54
Not Hispanic or Latino153
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Aml + Olm + Hctz
American Indian or Alaska Native1
Asian8
Native Hawaiian or Other Pacific Islander1
Black or African American35
White162
More than one race0
Unknown or Not Reported0
Stage of hypertension
Stage of hypertension(participants)Aml + Olm + Hctz
Stage 1115
Stage 292
Body mass index
Body mass index(mg/m2)Aml + Olm + Hctz
Mean32.80 ± 5.947
Mean 24-hour ambulatory diastolic blood pressure
Mean 24-hour ambulatory diastolic blood pressure(mm Hg)Aml + Olm + Hctz
Mean81.6 ± 9.76
Mean 24-hour ambulatory systolic blood pressure
Mean 24-hour ambulatory systolic blood pressure(mm Hg)Aml + Olm + Hctz
Mean144.4 ± 11.74

4 further baseline measures are reported on the registry.

08

Study locations

21 sites
  • Los Angeles, California, United States
  • Sylmar, California, United States
  • Tustin, California, United States
  • Aventura, Florida, United States
  • DeLand, Florida, United States
  • Hialeah, Florida, United States
  • Pembroke Pines, Florida, United States
  • Avon, Indiana, United States
  • Indianapolis, Indiana, United States
  • Las Vegas, Nevada, United States
  • New Windsor, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Charleston, South Carolina, United States
  • Greer, South Carolina, United States
  • Taylors, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Burke, Virginia, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00654745
Lead sponsor
Daiichi Sankyo
First posted
Apr 9, 2008
Start date
May 2008
Primary completion
Apr 2009
Completion
Jun 2009
Results posted
Jul 2, 2010
Last update
Jul 13, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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