Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

October 8, 2012 updated by: Pfizer

A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension

The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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
      • Birmingham, Alabama, United States, 35242
        • Cahaba Research Inc.
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Pulmonary Associates
    • California
      • Beverly Hills, California, United States, 90211
        • Impact Clinical Trials
      • Beverly Hills, California, United States, 90211
        • Lovelace Scientific Resources, Inc.
      • Buena Park, California, United States, 90620
        • Associated Pharmaceutical Research Center, Inc.
      • Greenbrae, California, United States, 94904
        • Marin Endocrine Care and Research
      • Long Beach, California, United States, 90806
        • Memorial Research Medical Clinic
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Los Angeles, California, United States, 90017
        • The Intermed Group; Samaritan Medical Tower
      • Roseville, California, United States, 95661
        • Clinical Trials Research
      • Studio City, California, United States, 91604
        • Bayview Research Group
      • Temecula, California, United States, 92591
        • Viking Clinical Research
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland, Inc.
      • Hollywood, Florida, United States, 33023
        • South Florida Clinical Research Center
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida
      • Miami, Florida, United States, 33156
        • International Research Associates, LLC
      • Miami, Florida, United States, 33186
        • Lifespan Research Foundation
      • New Port Richey, Florida, United States, 34652
        • Sun Coast Clinical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Palm Harbor, Florida, United States, 34684
        • Suncoast Clinical Research, Inc.
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Sarasota, Florida, United States, 34233
        • Lovelace Scientific Resources
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Center
      • Chicago, Illinois, United States, 60610
        • James R. Herron, MD, Ltd.
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine
      • Traverse City, Michigan, United States, 49684
        • Medical Research Associates
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Partners in Primary Care
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Assocites, LLC
      • Hickory, North Carolina, United States, 28601
        • Unifour Medical Research Associates
      • Raleigh, North Carolina, United States, 27609
        • Triangle Medical Research Associates
      • Statesville, North Carolina, United States, 28677
        • The Lipid Center
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group, Inc.
      • Marion, Ohio, United States, 43302
        • Smith Clinical Research
      • Mogadore, Ohio, United States, 44260
        • Radiant Research - Mogadore
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lion Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Medical Clinic Research Dept.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Philadelphia Health Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical Research South
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center, LLC
      • Greer, South Carolina, United States, 29651
        • Radiant Research - Greer
    • Texas
      • Austin, Texas, United States, 78704
        • Metaclin Research, Inc.
      • Carrollton, Texas, United States, 75006
        • Punzi Medical Center
      • Dallas, Texas, United States, 75234
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Radiant Research - San Antonio
      • San Antonio, Texas, United States, 78229
        • WellMed Medical Management
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Virginia Beach, Virginia, United States, 23455
        • The Chase Wellness Center, Inc
    • Washington
      • Lakewood, Washington, United States, 98499
        • Radiant Research - Tacoma

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure
  • History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
  • Liver or kidney disease
  • Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
  • Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.

Secondary Outcome Measures

Outcome Measure
Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily.
Compare the effect on the sitting and standing blood pressure among all treatment groups.
Compare the safety of each medication regimen stated above.
Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 20, 2006

First Posted (ESTIMATE)

July 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 8, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K749-06-3001
  • B5051001 (OTHER: Pfizer)

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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