Clinical trial NCT00527514: Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension
Official title: A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Stage I and II Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
timeFrame: Baseline to end of week 3
measure: Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
timeFrame: Baseline to end of week 6
measure: Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
timeFrame: Baseline to end of week 9
measure: Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
timeFrame: Baseline to end end of week 12
Other outcomes:
Locations:
city: Buena Park
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Tustin
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Castle Rock
country: United States
state: Colorado
city: Pembroke Pines
country: United States
state: Florida
city: Orland Park
country: United States
state: Illinois
city: Natick
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Beaver
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Carrolton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
Study officials:
References: