- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00063687
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
August 3, 2005 updated by: Advanz Pharma
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
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.
Study Overview
Study Type
Interventional
Enrollment
400
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oceanside, California, United States, 92056
- Carr-Dzindzio Cardiology
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New York
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New York, New York, United States, 10011
- Saint Vincents Hospital and Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joshua Hare, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
July 2, 2003
First Submitted That Met QC Criteria
July 2, 2003
First Posted (Estimate)
July 3, 2003
Study Record Updates
Last Update Posted (Estimate)
August 5, 2005
Last Update Submitted That Met QC Criteria
August 3, 2005
Last Verified
July 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500-02-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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