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Hexadecasaccharide

Phase 2

Coronary Atherosclerosis | Small molecule | Cardiovascular |Sanofi|Last Updated: Aug 21, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,257
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00123565Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial InfarctionPHASE2 COMPLETED 1,257 — — Dec 1, 2004May 1, 2007Aug 21, 200818 United States, Argentina +16
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Study Endpoints
Primary Endpoints
Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.
Secondary Endpoints
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Hexadecasaccharide (SR123781A)DRUG -
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours. * A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent Exclusion Criteria: * A person with known allergy or any...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileCzechiaFranceIndiaMexicoNetherlandsPolandPortugalRussiaSouth KoreaSpainTurkey (Türkiye)
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