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ticlopidine

Phase 3

Stable Angina | Small molecule | Cardiovascular |Sanofi|Last Updated: Jul 26, 2011

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,003
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00821834Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being PlannedPHASE3 COMPLETED 1,003 — — Dec 1, 2008Aug 1, 2010Jul 26, 20111 Japan
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Study Endpoints
Primary Endpoints
Time from randomization to first safety events of interest
12 Weeks (duble blind treatment period)

Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.

Secondary Endpoints
Time from randomization to first Major Adverse Cardiac Events (MACE)
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first bleeding events
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
ClopidogrelEXPERIMENTALPatients received: * clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, * ticlopidine matching placebo twice daily.
TiclopidineACTIVE_COMPARATORPatients received: * ticlopidine 100 mg twice daily, * clopidogrel matching placebo once daily.
Interventions
NameTypeDescription
clopidogrel (SR25990)DRUGForm: tablets Route: oral
ticlopidineDRUGForm: tablets Route: oral
PlaceboDRUGForm: tablets Route: oral
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Stable Angina / Old Myocardial Infarction patients who met all of the following criteria: * Myocardial ischemic finding was proven within 2 months before randomization, * Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography...

Countries:Japan
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