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”

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.

Intervention(s) in this Clinical Trial

• Drug: Amlodipine
  • Tablets
• Drug: Olmesartan medoxomil plus amlodipine
  • Tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
  • Time Frame: Baseline to 12 Weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
  • Time Frame: Baseline to 12 weeks
    Safety Issue?: No
• Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
  • Time Frame: Baseline to end of week 3
    Safety Issue?: No
• Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
  • Time Frame: Baseline to end of week 6
    Safety Issue?: No
• Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
  • Time Frame: Baseline to end of week 9
    Safety Issue?: No
• Change 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
    Safety Issue?: 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:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Daiichi Sankyo Inc. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00527514

Study ID Number: 8663-402

ClinicalTrials.gov Identifier: NCT00527514

Health Authority: United States: Food and Drug Administration