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

January 16, 2012 updated by: Daiichi Sankyo, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in systolic blood pressure from the start of the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 866-447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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