Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00355589
First received: July 20, 2006
Last updated: October 8, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Blood Pressure, High |
Drug: Ramipril and hydrochlorothiazide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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.
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355589
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Cahaba Research Inc. | |
| Birmingham, Alabama, United States, 35242 | |
| Clinical Research Associates | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pulmonary Associates | |
| Glendale, Arizona, United States, 85306 | |
| United States, California | |
| Impact Clinical Trials | |
| Beverly Hills, California, United States, 90211 | |
| Lovelace Scientific Resources, Inc. | |
| Beverly Hills, California, United States, 90211 | |
| Associated Pharmaceutical Research Center, Inc. | |
| Buena Park, California, United States, 90620 | |
| Marin Endocrine Care and Research | |
| Greenbrae, California, United States, 94904 | |
| Memorial Research Medical Clinic | |
| Long Beach, California, United States, 90806 | |
| The Intermed Group; Samaritan Medical Tower | |
| Los Angeles, California, United States, 90017 | |
| National Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Clinical Trials Research | |
| Roseville, California, United States, 95661 | |
| Bayview Research Group | |
| Studio City, California, United States, 91604 | |
| Viking Clinical Research | |
| Temecula, California, United States, 92591 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Clinical Research of West Florida, Inc. | |
| Clearwater, Florida, United States, 33765 | |
| Clinical Research of South Florida | |
| Coral Gables, Florida, United States, 33134 | |
| University Clinical Research Deland, Inc. | |
| Deland, Florida, United States, 32720 | |
| South Florida Clinical Research Center | |
| Hollywood, Florida, United States, 33023 | |
| Innovative Research of West Florida | |
| Largo, Florida, United States, 33770 | |
| International Research Associates, LLC | |
| Miami, Florida, United States, 33156 | |
| Lifespan Research Foundation | |
| Miami, Florida, United States, 33186 | |
| Sun Coast Clinical Research | |
| New Port Richey, Florida, United States, 34652 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Suncoast Clinical Research, Inc. | |
| Palm Harbor, Florida, United States, 34684 | |
| University Clinical Research, Inc. | |
| Pembroke Pines, Florida, United States, 33024 | |
| Lovelace Scientific Resources | |
| Sarasota, Florida, United States, 34233 | |
| Metabolic Research Institute, Inc. | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
| Executive Health and Research Associates, Inc. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| James R. Herron, MD, Ltd. | |
| Chicago, Illinois, United States, 60610 | |
| Cedar Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| Clinical Investigation Specialists, Inc. | |
| Gurnee, Illinois, United States, 60031 | |
| United States, Indiana | |
| Midwest Institute for Clinical Research | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Michigan | |
| Michigan Institute of Medicine | |
| Livonia, Michigan, United States, 48152 | |
| Medical Research Associates | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Minnesota | |
| Twin Cities Clinical Research | |
| Brooklyn Center, Minnesota, United States, 55430 | |
| United States, Nevada | |
| Advanced Biomedical Research of America | |
| Las Vegas, Nevada, United States, 89123 | |
| United States, New Jersey | |
| Partners in Primary Care | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, North Carolina | |
| Cumberland Research Assocites, LLC | |
| Fayetteville, North Carolina, United States, 28304 | |
| Unifour Medical Research Associates | |
| Hickory, North Carolina, United States, 28601 | |
| Triangle Medical Research Associates | |
| Raleigh, North Carolina, United States, 27609 | |
| The Lipid Center | |
| Statesville, North Carolina, United States, 28677 | |
| Piedmont Medical Research Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Lyndhurst Gynecologic Associates, PA | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Sterling Research Group, Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| Smith Clinical Research | |
| Marion, Ohio, United States, 43302 | |
| Radiant Research - Mogadore | |
| Mogadore, Ohio, United States, 44260 | |
| United States, Oklahoma | |
| Lion Research | |
| Norman, Oklahoma, United States, 73069 | |
| United States, Oregon | |
| Medford Medical Clinic Research Dept. | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Philadelphia Health Associates | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| United States, South Carolina | |
| Medical Research South | |
| Charleston, South Carolina, United States, 29407 | |
| SC Clinical Research Center, LLC | |
| Columbia, South Carolina, United States, 29201 | |
| Radiant Research - Greer | |
| Greer, South Carolina, United States, 29651 | |
| United States, Texas | |
| MetaClin Research, Inc. | |
| Austin, Texas, United States, 78704 | |
| Punzi Medical Center | |
| Carrollton, Texas, United States, 75006 | |
| Research Across America | |
| Dallas, Texas, United States, 75234 | |
| Radiant Research - San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| WellMed Medical Management | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Clinical Research Associates of Tidewater | |
| Norfolk, Virginia, United States, 23507 | |
| The Chase Wellness Center, Inc | |
| Virginia Beach, Virginia, United States, 23455 | |
| United States, Washington | |
| Radiant Research - Tacoma | |
| Lakewood, Washington, United States, 98499 | |
Sponsors and Collaborators
Pfizer
More Information
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00355589 History of Changes |
| Other Study ID Numbers: | K749-06-3001, B5051001 |
| Study First Received: | July 20, 2006 |
| Last Updated: | October 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Hypertension High Blood Pressure Diuretic Angiotensin converting enzyme inhibitor Ambulatory blood pressure monitoring |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Angiotensin-Converting Enzyme Inhibitors Ramipril Hydrochlorothiazide Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013