A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.

Key facts

Study ID

NCT01323153

Run by

Hoffmann-La Roche

People needed

300

Starts

2011-03-01

Expected to finish

2012-03-01

Last updated by the study team

2019-07-30

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, >/=45 years of age
• Patients admitted to the hospital for acute coronary syndrome (ACS)
• Patients receiving guideline-based medical and dietary management of dyslipidemia

You may not qualify if…

• Symptomatic congestive heart failure (NYHA Class III or IV)
• 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)

Where it is running

• Study site — Pensacola, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Saginaw, Michigan, United States
• Study site — Saint Cloud, Minnesota, United States
• Study site — Syracuse, New York, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Chrudim, Czechia
• Study site — České Budějovice, Czechia
• Study site — Hradec Králové, Czechia
• Study site — Jihlava, Czechia
• Study site — Jindřichův Hradec, Czechia
• Study site — Prague, Czechia
• Study site — Semily, Czechia
• Study site — Teplice, Czechia
• Study site — Zlín, Czechia
• Study site — Znojmo, Czechia
• Study site — Amsterdam, Netherlands
• Study site — Arnhem, Netherlands
• Study site — Beverwijk, Netherlands
• Study site — Breda, Netherlands
• Study site — Den Helder, Netherlands
• Study site — Eindhoven, Netherlands
• Study site — Gouda, Netherlands
• Study site — Heerlen, Netherlands
• Study site — Nieuwegein, Netherlands

Full record on ClinicalTrials.gov

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