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Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

NCT02525939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6147

Last updated 2022-10-12

Study results available
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Summary

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

dalcetrapib

Cholesterol Ester Transfer Protein inhibitor

DRUG

Placebo

matching placebo tablets

Sponsors & Collaborators

  • The Montreal Health Innovations Coordinating Center (MHICC)

    collaborator OTHER

  • Medpace, Inc.

    collaborator INDUSTRY

  • Roche Molecular Systems, Inc

    collaborator INDUSTRY

  • DalCor Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Donald M Black, MD · DalCor Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525939 on ClinicalTrials.gov