Trials / Completed
CompletedNCT00063687
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 400 (planned)
- Sponsor
- Advanz Pharma · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxypurinol |
Timeline
- Start date
- 2003-03-01
- Completion
- 2005-06-01
- First posted
- 2003-07-03
- Last updated
- 2005-08-05
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00063687. Inclusion in this directory is not an endorsement.