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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2007

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings