Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
NCT00050076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2012-02-02
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.
Conditions
- Congestive Heart Failure
Interventions
- DRUG
-
MCC-135
MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
- DRUG
-
MCC-135
MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks
- DRUG
-
MCC-135
MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks
- DRUG
-
MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
VP Clinical Science Strategy · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-08-31
- Primary Completion
- 2003-08-31
- Completion
- 2003-08-31
Countries
- United States
Study Locations
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