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dalcetrapib

Phase 3

Acute Coronary Syndrome | Small molecule | Cardiovascular |Medpace Holdings, Inc. Common Stock|Last Updated: Oct 12, 2022

Development status

Highest phase Phase 3
Registered trials 9 across 2 sponsors since Jul 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6,147

FDA Designations

No designations recorded

Clinical trial landscape

dalcetrapib · 1 trial · 1 indication

Phase 3 1
NCT02525939Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACSAcute Coronary Syndrome
COMPLETED6,147 Analytics
PHASE3COMPLETED
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Acute Coronary Syndrome
NCT025259396,147
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Study Endpoints

Primary Endpoints

Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)

All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.

Secondary Endpoints

Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DalcetrapibACTIVE_COMPARATORParticipants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
PlaceboPLACEBO_COMPARATORParticipants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets

Interventions

NameTypeDescription
dalcetrapibDRUGCholesterol Ester Transfer Protein inhibitor
PlaceboDRUGmatching placebo tablets
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Eligibility Criteria

Age Range45 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites557

Inclusion Criteria: * Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial. * AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigation...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileCzechiaDenmarkFinlandFranceGermanyHungaryIsraelItalyNetherlandsNew ZealandPolandPortugalPuerto RicoRomaniaRussiaSlovakiaSouth AfricaSpainSwedenSwitzerlandTurkey (Türkiye)United Arab EmiratesUnited Kingdom
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