Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II, Double-Blind, Randomized, Exploratory, Placebo-Controlled Study of Efficacy, Safety, and Tolerability of MCC-135 Comparing QD vs BID Doses in Subjects With Congestive Heart Failure, NYHA Class II/III|
- Change from baseline in the serum levels of brain natriuretic peptide [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
- Change from baseline in the Minnesota living with heart failure questionnaire score [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
- Regular rate (heart rate) variability as measured by 24-hour Holter monitoring [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
- Disease progression status measured by New York Heart Association class [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
- Disease progression status measured by Global Clinical Status [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
- Disease progression status measured by Clinical Composite [ Time Frame: At Final Visit. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||August 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
|Experimental: MCC-135 50 mg BID||
MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
|Experimental: MCC-135 100 mg QD||
MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks
|Experimental: MCC-135 200 mg QD||
MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks
|Placebo Comparator: Placebo||
MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050076
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|Study Director:||VP Clinical Science Strategy||Takeda|