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

Study Timeline

• Study Start: 2003-03
• Status Verified: 2003-07
• Study First Submitted: 2003-07-02
• Study First Submitted QC: 2003-07-02
• Study First Posted: 2003-07-03
• Study Completion: 2005-06
• Last Update Submitted: 2005-08-03
• Last Update Posted: 2005-08-05

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

Trial Locations

Locations (4)

Carr-Dzindzio Cardiology; 🇺🇸 Oceanside, California, United States

Saint Vincents Hospital and Medical Center; 🇺🇸 New York, New York, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States