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

Primary Purpose

Hypertension, Blood Pressure, High

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ramipril and hydrochlorothiazide
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, High Blood Pressure, Diuretic, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cahaba Research Inc.
  • Clinical Research Associates
  • Pulmonary Associates
  • Impact Clinical Trials
  • Lovelace Scientific Resources, Inc.
  • Associated Pharmaceutical Research Center, Inc.
  • Marin Endocrine Care and Research
  • Memorial Research Medical Clinic
  • The Intermed Group; Samaritan Medical Tower
  • National Research Institute
  • Clinical Trials Research
  • Bayview Research Group
  • Viking Clinical Research
  • University of Connecticut Health Center
  • Clinical Research of West Florida, Inc.
  • Clinical Research of South Florida
  • University Clinical Research Deland, Inc.
  • South Florida Clinical Research Center
  • Innovative Research of West Florida
  • International Research Associates, LLC
  • Lifespan Research Foundation
  • Sun Coast Clinical Research
  • Renstar Medical Research
  • Suncoast Clinical Research, Inc.
  • University Clinical Research, Inc.
  • Lovelace Scientific Resources
  • Metabolic Research Institute, Inc.
  • Executive Health and Research Associates, Inc.
  • Cedar Crosse Research Center
  • James R. Herron, MD, Ltd.
  • Clinical Investigation Specialists, Inc.
  • Midwest Institute for Clinical Research
  • Michigan Institute of Medicine
  • Medical Research Associates
  • Twin Cities Clinical Research
  • Advanced Biomedical Research of America
  • Partners in Primary Care
  • Cumberland Research Assocites, LLC
  • Unifour Medical Research Associates
  • Triangle Medical Research Associates
  • The Lipid Center
  • Lyndhurst Gynecologic Associates, PA
  • Piedmont Medical Research Associates
  • Sterling Research Group, Inc.
  • Smith Clinical Research
  • Radiant Research - Mogadore
  • Lion Research
  • Medford Medical Clinic Research Dept.
  • Philadelphia Health Associates
  • Medical Research South
  • SC Clinical Research Center, LLC
  • Radiant Research - Greer
  • MetaClin Research, Inc.
  • Punzi Medical Center
  • Research Across America
  • Radiant Research - San Antonio
  • WellMed Medical Management
  • Clinical Research Associates of Tidewater
  • The Chase Wellness Center, Inc
  • Radiant Research - Tacoma

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
July 20, 2006
Last Updated
October 8, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00355589
Brief Title
Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure, High
Keywords
Hypertension, High Blood Pressure, Diuretic, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ramipril and hydrochlorothiazide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
Title
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.
Title
Compare the effect on the sitting and standing blood pressure among all treatment groups.
Title
Compare the safety of each medication regimen stated above.
Title
Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cahaba Research Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Associated Pharmaceutical Research Center, Inc.
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Marin Endocrine Care and Research
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Memorial Research Medical Clinic
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
The Intermed Group; Samaritan Medical Tower
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Bayview Research Group
City
Studio City
State/Province
California
ZIP/Postal Code
91604
Country
United States
Facility Name
Viking Clinical Research
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
University Clinical Research Deland, Inc.
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
South Florida Clinical Research Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Innovative Research of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Lifespan Research Foundation
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Sun Coast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Executive Health and Research Associates, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
James R. Herron, MD, Ltd.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Michigan Institute of Medicine
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Medical Research Associates
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Twin Cities Clinical Research
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Partners in Primary Care
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Cumberland Research Assocites, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Unifour Medical Research Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Triangle Medical Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
The Lipid Center
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Lyndhurst Gynecologic Associates, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Smith Clinical Research
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Radiant Research - Mogadore
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Lion Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Medford Medical Clinic Research Dept.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Philadelphia Health Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Medical Research South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Radiant Research - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
MetaClin Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Punzi Medical Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Radiant Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
WellMed Medical Management
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
The Chase Wellness Center, Inc
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Radiant Research - Tacoma
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18463672
Citation
White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.
Results Reference
derived

Learn more about this trial

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

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