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

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

MedlinePlus related topics:

Heart Failure

Drug Information available for:

Oxypurinol

U.S. FDA Resources

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

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

Related Info This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Oxypurinol

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

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