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

NCT01323153

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Coronary Heart Disease

Interventions: dalcetrapib, placebo

Countries: United States, Czechia, Netherlands, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 45 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
Locations (33)
  • 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
  • + 3 more on CT.gov