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

This study has been completed.

First Received on September 9, 2005. Last Updated on January 16, 2012 History of Changes

Sponsor:	Daiichi Sankyo Inc.
Information provided by (Responsible Party):	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00185120

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Olmesartan medoxomil Drug: Hydroclorothiazide Drug: Benazepril Drug: Amlodipine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Calcium High Blood Pressure

Drug Information available for: Hydrochlorothiazide Calcium Gluconate Benazepril hydrochloride Benazepril Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil Lotrel

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change in systolic blood pressure from the start of the study

Secondary Outcome Measures:

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

Estimated Enrollment:	152
Study Start Date:	September 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185120

Locations

United States, Alabama

Mobile, Alabama, United States, 36693
United States, California
Memorial Research Medical Center
Long Beach, California, United States, 90806
National Research Institute
Los Angeles, California, United States, 90057
Clinical Trials Research
Roseville, California, United States, 95661
Apex Research Institute
Santa Ana, California, United States, 92705
Orange County Research Center
Tustin, California, United States, 92780
Westlake Medical Center
Westlake Village, California, United States, 91361
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
The Greater Fort Lauderdale Heart Group Research
Fort lauderdale, Florida, United States, 33308
SFBC International
Miami, Florida, United States, 33142
CLIRECO, Inc.
Tamarac, Florida, United States, 33321
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
Heartland Research Associates
Wichita, Kansas, United States, 67207
United States, Maine
Androscoggin Cardiology Research
Auburn, Maine, United States, 04210
United States, North Carolina
Internal Medicine Associates of Charlotte
Charlotte, North Carolina, United States, 28211
Piedmont Medical Research Associates
Winston-salem, North Carolina, United States, 27103
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45319
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Volunteer Research Group, University of Tennessee Med. Ctr.
Knoxville,, Tennessee, United States, 37920
United States, Texas
Punzi Medical Center
Carrollton, Texas, United States, 75006

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00185120 History of Changes
Other Study ID Numbers:	866-447
Study First Received:	September 9, 2005
Last Updated:	January 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Hypertension
angiotensin receptor blocker
calcium channel blocker
angiotensin converting enzyme inhibitor hydroclorothiazide

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Benazepril
Calcium Channel Blockers
Amlodipine
Hydrochlorothiazide
Olmesartan medoxomil
Olmesartan
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 21, 2012