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African-American Heart Failure Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00047775
Enrollment
1100
Registered
2002-10-21
Start date
2001-05-31
Completion date
2004-08-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Brief summary

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

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.

Interventions

DRUGBiDil

Sponsors

Nitromed
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026