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Colchicine,

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Last Updated: May 9, 2019

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_CONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01755949Colchicine and CRP in Atrial Fibrillation and AF AblationPHASE2 COMPLETED 26Mar 1, 2013Dec 6, 2016May 9, 20191 United States
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Study Endpoints
Primary Endpoints
Change in C-reactive Protein
baseline, day 28

Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Secondary Endpoints
Number of Subjects With Atrial Fibrillation
day 28
Time Course of C-reactive Protein Levels
baseline, day 3, day 7, day 14, day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chronic atrial fibrillation, colchicineACTIVE_COMPARATORColchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Chronic atrial fibrillation, placeboPLACEBO_COMPARATORMatching placebo. Subjects not undergoing ablation.
Pre-ablation, sinus rhythm, colchicineACTIVE_COMPARATORColchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, sinus rhythm, placeboPLACEBO_COMPARATORMatching placebo. Subjects undergoing ablation.
Pre-ablation, AF, colchicineACTIVE_COMPARATORColchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, AF, placeboPLACEBO_COMPARATORMatching placebo. Subjects undergoing ablation.
Interventions
NameTypeDescription
Colchicine, 0.6 mg PO BIDDRUGColchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Matching placeboDRUGMatching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG. * Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhy...

Countries:United States
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