Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
- Conditions
- Congestive Heart Failure
- Interventions
- Drug: PlaceboDrug: MCC-135
- Registration Number
- NCT00050076
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to determine the effect of two different doses of MCC-135, once daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects with congestive heart failure.
- Detailed Description
In recent years the usefulness of angiotensin converting enzyme inhibitors and vasodilators as well as beta-blockers has been realized in the treatment of heart failure. Multi-center studies clinical trials have shown some benefit of angiotensin converting enzyme inhibitors on the morbidity and mortality of heart failure subjects, and physicians are also prescribing angiotensin converting enzyme inhibitors for the initial treatment of subjects with left ventricular dysfunction. Some subjects do not respond to angiotensin converting enzyme inhibitors and intolerance to these compounds has also been observed. Despite the significant reduction in mortality observed in limited controlled studies, the 5-year mortality of subjects with congestive heart failure continues to be high, indicating that there is a significant therapeutic gap in the treatment of this disease.
MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subject's survival. The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subject's plasma b-type (brain) natriuretic peptide levels, regular rate (heart rate) variability and clinical signs and symptoms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MCC-135 50 mg BID MCC-135 - MCC-135 100 mg QD MCC-135 - MCC-135 200 mg QD MCC-135 -
- Primary Outcome Measures
Name Time Method Change from baseline in the serum levels of brain natriuretic peptide At Final Visit.
- Secondary Outcome Measures
Name Time Method Disease progression status measured by Global Clinical Status At Final Visit. Change from baseline in the Minnesota living with heart failure questionnaire score At Final Visit. Regular rate (heart rate) variability as measured by 24-hour Holter monitoring At Final Visit. Disease progression status measured by New York Heart Association class At Final Visit. Disease progression status measured by Clinical Composite At Final Visit.
Trial Locations
- Locations (51)
LAC & USC Medical Center
🇺🇸Los Angeles, California, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Medical Group of Fort Wayne, PC
🇺🇸Fort Wayne, Indiana, United States
Cardiology Associates of Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Southern Clinical Research & Management
🇺🇸Augusta, Georgia, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
Capitol Intervention Cardiology
🇺🇸Carmichael, California, United States
San Diego Cardiovascular
🇺🇸Encinitas, California, United States
Saint Vincent Catholic Medical Center
🇺🇸New York, New York, United States
Cardiovascular Research Institute of Dallas Medical Center - Cardiologist Research Foundation
🇺🇸Dallas, Texas, United States
The Stern Cardiovascular Center
🇺🇸Memphis, Tennessee, United States
North Ohio Research, Ltd.
🇺🇸Lorain, Ohio, United States
Bryan LGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Hudson Valley Clinical Research
🇺🇸Kingston, New York, United States
Chestnut Hill Cardiology, Ltd.
🇺🇸Flourtown, Pennsylvania, United States
Heart Care Center East
🇺🇸Fayetteville, New York, United States
South Jersey Heart Group
🇺🇸Sewell, New Jersey, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Med-Tech Research
🇺🇸Houston, Texas, United States
Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Alegent Health Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Clinical Trials Research
🇺🇸Roseville, California, United States
ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
🇺🇸Redondo Beach, California, United States
Cardiology Consultants PA
🇺🇸Daytona Beach, Florida, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Medical Center Cardiologist
🇺🇸Louisville, Kentucky, United States
Louisville Cardiology Medical Group, PSC
🇺🇸Louisville, Kentucky, United States
Louisiana Heart Center
🇺🇸Chalmette, Louisiana, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
University of Massachusettes
🇺🇸Worcester, Massachusetts, United States
Cardiology Associates, PC
🇺🇸Annapolis, Maryland, United States
Cardiovascular Consultants, PA
🇺🇸Takoma Park, Maryland, United States
City Cardiology Associates, Inc.
🇺🇸Stow, Ohio, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Carolina Research Associates
🇺🇸Columbia, South Carolina, United States
Tyler Cardiovascular Consultants
🇺🇸Tyler, Texas, United States
Cardiac Center of Louisiana, LLC
🇺🇸Shreveport, Louisiana, United States
Sacramento Heart & Vascular Medical Associates
🇺🇸Sacramento, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Cardiovascular Associates, Ltd.
🇺🇸Chesapeake, Virginia, United States
Wisconsin Center for Clinical Research, LLC
🇺🇸Elkhorn, Wisconsin, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States