Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
Phase 2
Completed
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT00063687
- Lead Sponsor
- Advanz Pharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Carr-Dzindzio Cardiology
🇺🇸Oceanside, California, 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, United States