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

This study has been completed.

Sponsor:

Information provided by:

Cardiome Pharma

ClinicalTrials.gov Identifier:

NCT00063687

First received: July 2, 2003

Last updated: August 3, 2005

Last verified: July 2003

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2003

Last Updated Date

August 3, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00063687 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Oxypurinol

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00063687

Other Study ID Numbers ^ICMJE

500-02-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cardiome Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joshua Hare, MD

Johns Hopkins University

Information Provided By

Cardiome Pharma

Verification Date

July 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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