NIH GUIDE, Volume 21, Number 41, November 13, 1992


P.T. 34



  Clinical Trial 


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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