Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
- 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-135 100 mg QD MCC-135 - MCC-135 200 mg QD MCC-135 - MCC-135 50 mg BID 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)
Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Capitol Intervention Cardiology
🇺🇸Carmichael, California, United States
San Diego Cardiovascular
🇺🇸Encinitas, California, United States
LAC & USC Medical Center
🇺🇸Los Angeles, California, United States
ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
🇺🇸Redondo Beach, California, United States
Clinical Trials Research
🇺🇸Roseville, California, United States
Sacramento Heart & Vascular Medical Associates
🇺🇸Sacramento, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Scroll for more (41 remaining)Maricopa Medical Center🇺🇸Phoenix, Arizona, United States