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

Condition(s) targeted: Hypertension; Blood Pressure, High

Intervention: Ramipril and hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: King Pharmaceuticals Research and Development

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.

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

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

Associated Pharmaceutical Research Center, Inc., Buena Park, California 90620, United States

National Research Institute, Los Angeles, California 90057, United States

Bayview Research Group, Studio City, California 91604, United States

Marin Endocrine Care and Research, Greenbrae, California 94904, United States

Memorial Research Medical Clinic, Long Beach, California 90806, United States

Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States

Clinical Trials Research, Roseville, California 95661, United States

The Intermed Group; Samaritan Medical Tower, Los Angeles, California 90017, United States

Viking Clinical Research, Temecula, California 92591, United States

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Lifespan Research Foundation, Miami, Florida 33186, United States

South Florida Clinical Research Center, Hollywood, Florida 33023, United States

International Research Associates, LLC, Miami, Florida 33156, United States

Sun Coast Clinical Research, New Port Richey, Florida 34652, United States

University Clinical Research Deland, Inc., Deland, Florida 32720, United States

Metabolic Research Institute, Inc., West Palm Beach, Florida 33401, United States

Suncoast Clinical Research, Inc., Palm Harbor, Florida 34684, United States

Clinical Research of South Florida, Coral Gables, Florida 33134, United States

Clinical Research of West Florida, Inc., Clearwater, Florida 33765, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Renstar Medical Research, Ocala, Florida 34471, United States

Lovelace Scientific Resources, Sarasota, Florida 34233, United States

Innovative Research of West Florida, Largo, Florida 33770, United States

Executive Health and Research Associates, Inc., Atlanta, Georgia 30342, United States

James R. Herron, MD, Ltd., Chicago, Illinois 60610, United States

Clinical Investigation Specialists, Inc., Gurnee, Illinois 60031, United States

Cedar Crosse Research Center, Chicago, Illinois 60607, 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, New Jersey 08043, United States

The Lipid Center, Statesville, North Carolina 28677, United States

Triangle Medical Research Associates, Raleigh, North Carolina 27609, United States

Unifour Medical Research Associates, Hickory, North Carolina 28601, United States

Lyndhurst Gynecologic Associates, PA, Winston-Salem, North Carolina 27103, United States

Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States

Cumberland Research Assocites, LLC, Fayetteville, North Carolina 28304, 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

Radiant Research - Greer, Greer, South Carolina 29651, United States

SC Clinical Research Center, LLC, Columbia, South Carolina 29201, United States

Radiant Research - San Antonio, San Antonio, Texas 78229, United States

MetaClin Research, Inc., Austin, Texas 78704, United States

WellMed Medical Management, San Antonio, Texas 78229, United States

Punzi Medical Center, Carrollton, Texas 75006, United States

Research Across America, Dallas, Texas 75234, United States

The Chase Wellness Center, Inc, Virginia Beach, Virginia 23455, United States

Clinical Research Associates of Tidewater, Norfolk, Virginia 23507, United States

Radiant Research - Tacoma, Lakewood, Washington 98499, United States

Last updated: November 12, 2007