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NCT00047775 Clinical Trial

African-American Heart Failure Trial

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00047775
Other study ID # A-HeFT
Secondary ID
Status Completed
Phase Phase 4
First received October 18, 2002
Last updated June 23, 2005
Start date May 2001
Est. completion date August 2004

Study information
Verified date October 2004
Source Nitromed
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

Description:

The overall objective is confirmation of BiDil’s Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.

Recruitment information / eligibility
Status Completed
Enrollment 1100
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - African American male or female 18 years or older.

- NYHA Class 3 & 4.

- Have either a resting LVEF less than or equal to 35% (by any method) or a resting LVIDD greater than 2.9 cm/m2 BSA (or greater than 6.5 cm) with LVEF less than 45% (by echocardiogram).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BiDil

Locations
Country Name City State
United States Miami International Cardiology Consultants Aventura Florida
United States Cooper Green Hospital Birmingham Alabama
United States Boston Medical Center Boston Massachusetts
United States Cardiology and Medicine Clinic Little Rock Arkansas
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Saint Vincents Hospital and Medical Center New York New York
United States Howard University Hospital Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Nitromed

Country where clinical trial is conducted

United States, 

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