Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063687
• Other study ID #: 500-02-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 2, 2003
• Last updated: August 3, 2005
• Start date: March 2003
• Est. completion date: June 2005

Study information

• Verified date: July 2003
• Source: Cardiome Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria

• 18-85 years old,

• Stable NYHA Class III-IV

• Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen.

• EF =< 40%

Exclusion criteria

• Any condition (other than CHF) that could limit exercise

• Any concurrent disease likely to limit life expectancy.

• Participation in another clinical trial

• Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy

• Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

Study Design

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Oxypurinol

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Saint Vincents Hospital and Medical Center	New York	New York
United States	Carr-Dzindzio Cardiology	Oceanside	California

Sponsors (1)

Lead Sponsor	Collaborator
Cardiome Pharma

Country where clinical trial is conducted

United States, 

External Links

•   Link