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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

MCC-135 · 1 trial · 1 indication

Phase 2 1
NCT00050076Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.Congestive Heart Failure
COMPLETED204 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
Congestive Heart FailureUnlock trial analytics

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 to 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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Frequently asked questions about MCC-135

What is MCC-135 used for?

MCC-135 is an investigational small molecule being studied for the treatment of congestive heart failure. It is being developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in Phase 2 clinical development and is not yet approved for any use.

Who makes MCC-135?

MCC-135 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The drug is a small molecule in Phase 2 clinical development for congestive heart failure.

What phase is MCC-135 in?

MCC-135 is in Phase 2 clinical development. It is an investigational drug for congestive heart failure and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.

What clinical trials is MCC-135 in?

MCC-135 has one completed Phase 2 clinical trial, identified as NCT00050076. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of once and twice daily doses of MCC-135 in 204 subjects with congestive heart failure in the United States.

Is MCC-135 FDA approved?

MCC-135 is not FDA approved. It is an investigational drug in Phase 2 clinical development for congestive heart failure. The completed clinical trial NCT00050076 was a safety and efficacy study, but the drug has not received marketing approval.