A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
NCT ID: NCT01323153
Last Updated: 2019-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2011-03-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dalcetrapib
dalcetrapib
Oral doses of 600 mg once daily for 20 weeks
Placebo
placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Interventions
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dalcetrapib
Oral doses of 600 mg once daily for 20 weeks
placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients admitted to the hospital for acute coronary syndrome (ACS)
* Patients receiving guideline-based medical and dietary management of dyslipidemia
Exclusion Criteria
* Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
* Uncontrolled hypertension
* Uncontrolled diabetes
* Severe anemia
* Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
45 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pensacola, Florida, United States
Pensacola, Florida, United States
Saginaw, Michigan, United States
Saint Cloud, Minnesota, United States
Syracuse, New York, United States
Rapid City, South Dakota, United States
Chrudim, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Jihlava, , Czechia
Jindřichův Hradec, , Czechia
Prague, , Czechia
Semily, , Czechia
Teplice, , Czechia
Zlín, , Czechia
Znojmo, , Czechia
Amsterdam, , Netherlands
Arnhem, , Netherlands
Beverwijk, , Netherlands
Breda, , Netherlands
Den Helder, , Netherlands
Eindhoven, , Netherlands
Gouda, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Sneek, , Netherlands
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Stoke-on-Trent, , United Kingdom
Swansea, , United Kingdom
Countries
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Other Identifiers
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WC25501
Identifier Type: -
Identifier Source: org_study_id
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