Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

Condition(s) targeted: Hypertension

Intervention: Olmesartan medoxomil (Drug); Hydroclorothiazide (Drug); Benazepril (Drug); Amlodipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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

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

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

Primary outcome: Change in systolic blood pressure from the start of the study

Secondary outcome:

Change in diastolic blood pressure from the start of the study

Percent of patients who achieve target blood pressure goals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mobile, Alabama 36693, United States

Memorial Research Medical Center, Long Beach, California 90806, United States

National Research Institute, Los Angeles, California 90057, United States

Orange County Research Center, Tustin, California 92780, United States

Westlake Medical Center, Westlake Village, California 91361, United States

Apex Research Institute, Santa Ana, California 92705, United States

Clinical Trials Research, Roseville, California 95661, United States

SFBC International, Miami, Florida 33142, United States

The Greater Fort Lauderdale Heart Group Research, Fort lauderdale, Florida 33308, United States

CLIRECO, Inc., Tamarac, Florida 33321, United States

Clinical Research of South Florida, coral gables, Florida 33134, United States

Midwest Institute for Clinical Research, Indianapolis, Indiana 46260, United States

Heartland Research Associates, Wichita, Kansas 67207, United States

Androscoggin Cardiology Research, Auburn, Maine 04210, United States

Internal Medicine Associates of Charlotte, Charlotte, North Carolina 28211, United States

Piedmont Medical Research Associates, Winston-salem, North Carolina 27103, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45319, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Volunteer Research Group, University of Tennessee Med. Ctr., Knoxville,, Tennessee 37920, United States

Punzi Medical Center, Carrollton, Texas 75006, United States

Starting date: September 2005
Last updated: March 27, 2007