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

Advanz Pharma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Congestive Heart Failure

Treatments

Drug: Oxypurinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063687

500-02-01

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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