CompletedNCT00527514Updated Nov 11, 2009Results posted

Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

A Phase 3 interventional study of Amlodipine and Olmesartan medoxomil plus amlodipine in Hypertension, sponsored by Daiichi Sankyo. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-11.

Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 185
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,687

Keywords

Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Stage I and II Hypertension

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 185 is above the median of 90 across 4,994 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.

Who can participate

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

Inclusion criteria

Males or females greater than or equal to 18 years of age
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion criteria

Exclusion Criteria:

History of stroke or transient ischemic attack (TIA) within the last one year
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose \<160 mg/dl may enroll
Patients with hemodynamically significant cardiac valvular disease
Patients with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 185 participants (actual)

Study arms

Experimental
1
Drug: Amlodipine · Drug: Olmesartan medoxomil plus amlodipine

Interventions

DrugAmlodipine
Tablets
DrugOlmesartan medoxomil plus amlodipine
Tablets

What researchers measure

Primary outcomes

Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
Time frame: Baseline to 12 Weeks

Secondary outcomes

Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Time frame: Baseline to 12 weeks
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Time frame: Baseline to end of week 3
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Time frame: Baseline to end of week 6
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Time frame: Baseline to end of week 9
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Time frame: Baseline to end end of week 12

Results

Posted Sep 23, 2009

Participant flow

Participants were recruited at 18 US sites over 4 months (September 2007 to December 2007) from each physician's clientele base. Approximately 150 eligible participants, men and women at least 18 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment

Weeks 1-3: Amlodipine (Aml) 5mg

Participant flow — Weeks 1-3: Amlodipine (Aml) 5mg
Milestone	Amlodipine and Olmesartan, if Necessary
Started	185
Completed	184
Not completed	1
Withdrew: Adverse event	1

Weeks 4-6: Aml 5mg+Olmesartan 20 mg

Participant flow — Weeks 4-6: Aml 5mg+Olmesartan 20 mg
Milestone	Amlodipine and Olmesartan, if Necessary
Started	180
Completed	178
Not completed	2
Withdrew: Withdrawal by subject	2

Weeks 7-9: Aml 5 mg + Olmesartan 40 mg

Participant flow — Weeks 7-9: Aml 5 mg + Olmesartan 40 mg
Milestone	Amlodipine and Olmesartan, if Necessary
Started	161
Completed	158
Not completed	3
Withdrew: Adverse event	1
Withdrew: Lost to follow-up	1
Withdrew: Withdrawal by subject	1

Weeks 10-12:Aml 10 mg +Olmesartan 40 mg

Participant flow — Weeks 10-12:Aml 10 mg +Olmesartan 40 mg
Milestone	Amlodipine and Olmesartan, if Necessary
Started	134
Completed	132
Not completed	2
Withdrew: Adverse event	1
Withdrew: Withdrawal by subject	1

Outcome measures

PrimaryChange From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring

Time frame:: Baseline to 12 Weeks
Reported as:: Mean · mm Hg

Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
mm Hg	Overall Active Treatment Period
Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring	-21.4 ± 0.80

Statistical analysis

Overall Active Treatment Period · one-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure

Time frame:: Baseline to 12 weeks
Reported as:: Mean · mm Hg

Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
mm Hg	Overall Active Treatment Period
Daytime	-23.1 ± 0.92
Nighttime	-18.5 ± 0.91

Statistical analysis

Overall Active Treatment Period · One-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.

Time frame:: Baseline to end of week 3
Reported as:: Mean · mm Hg

Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
mm Hg	Group 1 Amlodipine 5 mg
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.	-10.1 ± 0.97

Statistical analysis

Group 1 Amlodipine 5 mg · One-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.

Time frame:: Baseline to end of week 6
Reported as:: Mean · mm Hg

Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
mm Hg	Group 2 - Aml 5 mg + Olmesartan 20 mg
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.	-18.0 ± 0.92

Statistical analysis

Group 2 - Aml 5 mg + Olmesartan 20 mg · one-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group

Time frame:: Baseline to end of week 9
Reported as:: Mean · mm Hg

Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
mm Hg	Group 3 - Aml 5 mg + Olm 40 mg
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group	-20.5 ± 1.01

Statistical analysis

Group 3 - Aml 5 mg + Olm 40 mg · One-sample t-test · p = <0.0001 (No multiplicity adjustments)

SecondaryChange From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group

Time frame:: Baseline to end end of week 12
Reported as:: Mean · mm Hg

Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
mm Hg	Group 4 - Aml 10 mg + Olm 40 mg
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group	-24.6 ± 1.18

Statistical analysis

Group 4 - Aml 10 mg + Olm 40 mg · one-sample t-test · p = <0.0001 (No multiplicity adjustments)

Adverse events

Collected over 12 week treatment period plus 30 days after the last dose.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Amlodipine 5 mg	—	0/185 (0%)	8/185 (4.3%)
Amlodipine 5mg and Olmesartan 20 mg	—	0/180 (0%)	23/180 (12.8%)
Amlodipine 5mg and Olmesartan 40 mg	—	1/161 (0.6%)	11/161 (6.8%)
Amlodipine 10 mg and Olmesartan 40 mg	—	1/134 (0.7%)	12/134 (9%)

Most frequent serious events

Most frequent serious events
Event	Amlodipine 5 mg	Amlodipine 5mg and Olmesartan 20 mg	Amlodipine 5mg and Olmesartan 40 mg	Amlodipine 10 mg and Olmesartan 40 mg
Transient ischemic attackVascular disorders	0/185	0/180	0/161	1/134
Limb amputationInjury, poisoning and procedural complications	0/185	0/180	1/161	0/134

Most frequent other events

Most frequent other events
Event	Amlodipine 5 mg	Amlodipine 5mg and Olmesartan 20 mg	Amlodipine 5mg and Olmesartan 40 mg	Amlodipine 10 mg and Olmesartan 40 mg
NasopharyngitisInfections and infestations	1/185	9/180	2/161	5/134
Oedema PeripheralGeneral disorders	3/185	5/180	2/161	2/134
Joint swellingMusculoskeletal and connective tissue disorders	1/185	2/180	2/161	3/134
Upper respiratory tract infectionInfections and infestations	1/185	4/180	3/161	1/134
DizzinessNervous system disorders	2/185	3/180	2/161	1/134

Baseline characteristics

Age Continuous
Age Continuous(years)	Amlodipine and Olmesartan, if Necessary
Mean	56.8 ± 9.28

Sex: Female, Male
Sex: Female, Male(Participants)	Amlodipine and Olmesartan, if Necessary
Female	80
Male	105

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Amlodipine and Olmesartan, if Necessary
Asian	14
Black or African American	26
White	144
American Indian or Alaska Native	1

Region of Enrollment
Region of Enrollment(participants)	Amlodipine and Olmesartan, if Necessary
United States	185

Stage of Hypertension
Stage of Hypertension(Participants)	Amlodipine and Olmesartan, if Necessary
Stage 1	82
Stage 2	103

24-Hour Ambulatory Diastolic Blood Pressure
24-Hour Ambulatory Diastolic Blood Pressure(mm Hg)	Amlodipine and Olmesartan, if Necessary
Mean	85.8 ± 7.91

24-hour Ambulatory Systolic Blood Pressure
24-hour Ambulatory Systolic Blood Pressure(mm Hg)	Amlodipine and Olmesartan, if Necessary
Mean	144.6 ± 10.88

Heart Rate
Heart Rate(beats/minute)	Amlodipine and Olmesartan, if Necessary
Mean	75.1 ± 10.82

1 further baseline measures are reported on the registry.

Study locations

18 sites

Buena Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Tustin, California, United States
Westlake Village, California, United States
Castle Rock, Colorado, United States
Pembroke Pines, Florida, United States
Orland Park, Illinois, United States
Natick, Massachusetts, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Beaver, Pennsylvania, United States
Greer, South Carolina, United States
Carrolton, Texas, United States
Corpus Christi, Texas, United States
Madison, Wisconsin, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00527514
Lead sponsor: Daiichi Sankyo
First posted: Sep 11, 2007
Start date: Sep 2007
Primary completion: Apr 2008
Completion: Apr 2008
Results posted: Sep 23, 2009
Last update: Nov 11, 2009

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hypertension

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria