Hypertension Clinical Trial
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
| Verified date | October 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | March 2007 |
| Est. primary completion date | March 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Executive Health and Research Associates, Inc. | Atlanta | Georgia |
| United States | MetaClin Research, Inc. | Austin | Texas |
| United States | Impact Clinical Trials | Beverly Hills | California |
| United States | Lovelace Scientific Resources, Inc. | Beverly Hills | California |
| United States | Cahaba Research Inc. | Birmingham | Alabama |
| United States | Twin Cities Clinical Research | Brooklyn Center | Minnesota |
| United States | Associated Pharmaceutical Research Center, Inc. | Buena Park | California |
| United States | Punzi Medical Center | Carrollton | Texas |
| United States | Medical Research South | Charleston | South Carolina |
| United States | Cedar Crosse Research Center | Chicago | Illinois |
| United States | James R. Herron, MD, Ltd. | Chicago | Illinois |
| United States | Sterling Research Group, Inc. | Cincinnati | Ohio |
| United States | Clinical Research of West Florida, Inc. | Clearwater | Florida |
| United States | SC Clinical Research Center, LLC | Columbia | South Carolina |
| United States | Clinical Research of South Florida | Coral Gables | Florida |
| United States | Research Across America | Dallas | Texas |
| United States | University Clinical Research Deland, Inc. | Deland | Florida |
| United States | University of Connecticut Health Center | Farmington | Connecticut |
| United States | Cumberland Research Assocites, LLC | Fayetteville | North Carolina |
| United States | Pulmonary Associates | Glendale | Arizona |
| United States | Marin Endocrine Care and Research | Greenbrae | California |
| United States | Radiant Research - Greer | Greer | South Carolina |
| United States | Clinical Investigation Specialists, Inc. | Gurnee | Illinois |
| United States | Unifour Medical Research Associates | Hickory | North Carolina |
| United States | South Florida Clinical Research Center | Hollywood | Florida |
| United States | Clinical Research Associates | Huntsville | Alabama |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Radiant Research - Tacoma | Lakewood | Washington |
| United States | Innovative Research of West Florida | Largo | Florida |
| United States | Advanced Biomedical Research of America | Las Vegas | Nevada |
| United States | Michigan Institute of Medicine | Livonia | Michigan |
| United States | Memorial Research Medical Clinic | Long Beach | California |
| United States | National Research Institute | Los Angeles | California |
| United States | The Intermed Group; Samaritan Medical Tower | Los Angeles | California |
| United States | Smith Clinical Research | Marion | Ohio |
| United States | Medford Medical Clinic Research Dept. | Medford | Oregon |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Lifespan Research Foundation | Miami | Florida |
| United States | Radiant Research - Mogadore | Mogadore | Ohio |
| United States | Sun Coast Clinical Research | New Port Richey | Florida |
| United States | Clinical Research Associates of Tidewater | Norfolk | Virginia |
| United States | Lion Research | Norman | Oklahoma |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Suncoast Clinical Research, Inc. | Palm Harbor | Florida |
| United States | University Clinical Research, Inc. | Pembroke Pines | Florida |
| United States | Philadelphia Health Associates | Philadelphia | Pennsylvania |
| United States | Triangle Medical Research Associates | Raleigh | North Carolina |
| United States | Clinical Trials Research | Roseville | California |
| United States | Radiant Research - San Antonio | San Antonio | Texas |
| United States | WellMed Medical Management | San Antonio | Texas |
| United States | Lovelace Scientific Resources | Sarasota | Florida |
| United States | The Lipid Center | Statesville | North Carolina |
| United States | Bayview Research Group | Studio City | California |
| United States | Viking Clinical Research | Temecula | California |
| United States | Medical Research Associates | Traverse City | Michigan |
| United States | The Chase Wellness Center, Inc | Virginia Beach | Virginia |
| United States | Partners in Primary Care | Voorhees | New Jersey |
| United States | Metabolic Research Institute, Inc. | West Palm Beach | Florida |
| United States | Lyndhurst Gynecologic Associates, PA | Winston-Salem | North Carolina |
| United States | Piedmont Medical Research Associates | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily. | |||
| Secondary | 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. | |||
| Secondary | Compare the effect on the sitting and standing blood pressure among all treatment groups. | |||
| Secondary | Compare the safety of each medication regimen stated above. | |||
| Secondary | Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above. |
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