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

This study has been completed.

First Received: July 2, 2003 Last Updated: August 3, 2005 History of Changes

Sponsor:	Cardiome Pharma
Information provided by:	Cardiome Pharma
ClinicalTrials.gov Identifier:	NCT00063687

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Oxypurinol	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Oxypurinol

U.S. FDA Resources

Further study details as provided by Cardiome Pharma:

Estimated Enrollment:	400
Study Start Date:	March 2003
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063687

Locations

United States, California
Carr-Dzindzio Cardiology
Oceanside, California, United States, 92056
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Saint Vincents Hospital and Medical Center
New York, New York, United States, 10011

Sponsors and Collaborators

Cardiome Pharma

Investigators

Principal Investigator:

Joshua Hare, MD

Johns Hopkins University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	500-02-01
Study First Received:	July 2, 2003
Last Updated:	August 3, 2005
ClinicalTrials.gov Identifier:	NCT00063687 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Cardiovascular Diseases
Oxypurinol
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009