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

A

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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