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Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure Clinical research trials and Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure. Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure clinical trial. Human subjects frequently get the finest healthcare available for their Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure
Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure
For Condition: Congestive Heart Failure
Status: Recruiting
Sponsor(s): Cardiome Pharma ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
JoshuaHare, Principal Investigator, Johns Hopkins University
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Elayne Breton 410-955-1160
Saint Vincents Hospital and Medical Center *Recruiting*
New York City, New York, 10011
United States
Recruiting Robin Giordano 212-604-2215
Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Lorraine Keane 617-638-8757
Carr-Dzindzio Cardiology *Recruiting*
Oceanside, California, 92056
United States
Recruiting Michelle Peek 760-941-9440
Comprehensive Adult Risk Evaluation *Recruiting*
Oakland, California, 92056
United States
Recruiting Jackie Rayford 510-987-8616
Additional Information:
Study ID Numbers: 500-02-01;
Study Start Date: March 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063687
Other Congestive Heart Failure Studies:
1. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)
2. Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
3. The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
4. Autologous Cultured Myoblasts (BioWhittaker) Transplanted via Myocardial Injection
5. Safety and Efficacy Study of carvedilol to treat children with congestive heart failure
Related Studies:
Other Congestive Heart Failure Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure
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