Official Title: “A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension”

A comparison of 2 different combinations of high blood pressure medications to treat hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Olmesartan medoxomil
• Drug: Hydroclorothiazide
• Drug: Benazepril
• Drug: Amlodipine

Primary Measures

• Change in systolic blood pressure from the start of the study

Secondary Measures

• Change in diastolic blood pressure from the start of the study
• Percent of patients who achieve target blood pressure goals

Inclusion Criteria:

• Greater than 18 years of age
• Patients with high blood pressure

Exclusion Criteria:

• Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months
• History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
• Type 1 diabetes mellitus

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 Sponsor: Daiichi Sankyo Inc.

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185120

Study ID Number: 866-447

ClinicalTrials.gov Identifier: NCT00185120

Health Authority: United States: Food and Drug Administration