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MCC-135

Phase 2

Congestive Heart Failure | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00050076Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.PHASE2 COMPLETED 204Aug 1, 2002Aug 1, 2003Feb 2, 201253 United States
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Study Endpoints
Primary Endpoints
Change from baseline in the serum levels of brain natriuretic peptide
At Final Visit.
Secondary Endpoints
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.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MCC-135 50 mg BIDEXPERIMENTAL -
MCC-135 100 mg QDEXPERIMENTAL -
MCC-135 200 mg QDEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MCC-135DRUGMCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
PlaceboDRUGMCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion: * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Having a clinical diagnosis consistent with congestive heart failure, of at least 6 month...

Countries:United States
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