CLINICAL TRIALS CENTER FOR ANTIHYPERTENSIVE AND LIPID-LOWERINGTREATMENT TO PREVENT HEART ATTACK TRIAL NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFP AVAILABLE: NHLBI-HC-93-44 P.T. 34 Keywords: Hypertension Clinical Trial Pharmaceuticals National Heart, Lung, and Blood Institute The primary purpose of this program is to select a Clinical Trials Center to conduct a practice-based, randomized clinical trial of antihypertensive pharmacologic treatment and, in a specific subset, lipid-lowering, in a factorial design. The purpose of the antihypertensive trial is to determine whether or not the combined incidence of fatal coronary heart disease (CHD) and non-fatal myocardial infarction differs between diuretic-based and alternative antihypertensive pharmacologic treatment in patients broadly representative of the U.S. hypertensive population, including at least 55 percent African-Americans. The purpose of the lipid-lowering trial is to conduct, in a subset of this population and in a factorial design, a placebo-controlled randomized clinical trial to determine whether or not lowering serum cholesterol in older, moderately hypercholesterolemic men and women with a 3-hydroxymethylglutaryl coenzyme A (HMG CoA) reductase inhibitor will reduce the combined incidence of fatal CHD and non-fatal myocardial infarction. Rather than using independently funded clinics, patients will be recruited through office-based practices and hypertension clinics that will be reimbursed by the Clinical Trials Center on a per-patient basis. The study will consist of a vanguard phase and a full-scale trial phase. Six hundred patients will be entered into the vanguard phase; approximately 30,000 patients will be enrolled in the full-scale trial. This is not a Request for Proposals (RFP). RFP NHLBI-HC-93-44 will be released on or about November 6, 1992 with proposals due on or about January 15, 1993. One incrementally funded contract is anticipated to be awarded for nine years. Written requests must include three self-addressed mailing labels and must cite RFP NHLBI-HC-93-44. Requests for copies of the RFP are to be sent to: Kristee M. Camilletti, Contracting Officer HLVD Contracts Section, Contracts Operations Branch, DEA National Heart, Lung, and Blood Institute Federal Building, Room 4C04 Bethesda, MD 20892 .
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