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Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Sponsor: DalCor Pharmaceuticals
Summary
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 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. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from 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 (up to12 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.
Official title: Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2023-10-03
Completion Date
2027-08
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Dalcetrapib
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
Placebo
matching placebo tablets
Locations (223)
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Fairhope, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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North Little Rock, Arkansas, United States
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Garden Grove, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Newport Beach, California, United States
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San Francisco, California, United States
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Santa Barbara, California, United States
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Stanford, California, United States
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Torrance, California, United States
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West Hills, California, United States
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Aurora, Colorado, United States
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Golden, Colorado, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Miami Lakes, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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Sarasota, Florida, United States
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Nottingham, Maryland, United States
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Mount Clemens, Michigan, United States
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Petoskey, Michigan, United States
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Traverse City, Michigan, United States
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Ypsilanti, Michigan, United States
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