Trial | NCT00063687  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxypurinol ...

  • Study Participants

    400
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.
Study Started
Mar 31
2003
Study Completion
Jun 30
2005
Last Update
Aug 05
2005
Estimate

Drug Oxypurinol

Criteria 

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
No Results Posted