Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
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
2 other identifiers
interventional
N/A
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2006
Shorter than P25 for phase_3 hypertension
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 20, 2006
CompletedFirst Posted
Study publicly available on registry
July 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedOctober 10, 2012
October 1, 2012
8 months
July 20, 2006
October 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (60)
Cahaba Research Inc.
Birmingham, Alabama, 35242, United States
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Pulmonary Associates
Glendale, Arizona, 85306, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620, United States
Marin Endocrine Care and Research
Greenbrae, California, 94904, United States
Memorial Research Medical Clinic
Long Beach, California, 90806, United States
The Intermed Group; Samaritan Medical Tower
Los Angeles, California, 90017, United States
National Research Institute
Los Angeles, California, 90057, United States
Clinical Trials Research
Roseville, California, 95661, United States
Bayview Research Group
Studio City, California, 91604, United States
Viking Clinical Research
Temecula, California, 92591, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
University Clinical Research Deland, Inc.
DeLand, Florida, 32720, United States
South Florida Clinical Research Center
Hollywood, Florida, 33023, United States
Innovative Research of West Florida
Largo, Florida, 33770, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Lifespan Research Foundation
Miami, Florida, 33186, United States
Sun Coast Clinical Research
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Lovelace Scientific Resources
Sarasota, Florida, 34233, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Executive Health and Research Associates, Inc.
Atlanta, Georgia, 30342, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
James R. Herron, MD, Ltd.
Chicago, Illinois, 60610, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Michigan Institute of Medicine
Livonia, Michigan, 48152, United States
Medical Research Associates
Traverse City, Michigan, 49684, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Partners in Primary Care
Voorhees Township, New Jersey, 08043, United States
Cumberland Research Assocites, LLC
Fayetteville, North Carolina, 28304, United States
Unifour Medical Research Associates
Hickory, North Carolina, 28601, United States
Triangle Medical Research Associates
Raleigh, North Carolina, 27609, United States
The Lipid Center
Statesville, North Carolina, 28677, United States
Lyndhurst Gynecologic Associates, PA
Winston-Salem, North Carolina, 27103, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group, Inc.
Cincinnati, Ohio, 45219, United States
Smith Clinical Research
Marion, Ohio, 43302, United States
Radiant Research - Mogadore
Mogadore, Ohio, 44260, United States
Lion Research
Norman, Oklahoma, 73069, United States
Medford Medical Clinic Research Dept.
Medford, Oregon, 97504, United States
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146, United States
Medical Research South
Charleston, South Carolina, 29407, United States
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201, United States
Radiant Research - Greer
Greer, South Carolina, 29651, United States
MetaClin Research, Inc.
Austin, Texas, 78704, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
Research Across America
Dallas, Texas, 75234, United States
Radiant Research - San Antonio
San Antonio, Texas, 78229, United States
WellMed Medical Management
San Antonio, Texas, 78229, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
The Chase Wellness Center, Inc
Virginia Beach, Virginia, 23455, United States
Radiant Research - Tacoma
Lakewood, Washington, 98499, United States
Related Publications (1)
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.
PMID: 18463672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2006
First Posted
July 24, 2006
Study Start
July 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
October 10, 2012
Record last verified: 2012-10