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African-American Heart Failure Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047775
First Posted: October 21, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nitromed
  Purpose
A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

Condition Intervention Phase
Congestive Heart Failure Drug: BiDil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nitromed:

Estimated Enrollment: 1100
Study Start Date: May 2001
Estimated Study Completion Date: August 2004
Detailed Description:
The overall objective is confirmation of BiDil’s Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047775


Locations
United States, Alabama
Cooper Green Hospital
Birmingham, Alabama, United States, 35233
United States, Arkansas
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States, 72204
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Miami International Cardiology Consultants
Aventura, Florida, United States, 33180
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, New York
Saint Vincents Hospital and Medical Center
New York, New York, United States, 10011
Sponsors and Collaborators
Nitromed
Investigators
Study Chair: Anne L. Taylor, M.D. University of Minnesota - Clinical and Translational Science Institute