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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01323153
First received: March 24, 2011
Last updated: July 7, 2014
Last verified: July 2014

March 24, 2011
July 7, 2014
March 2011
March 2012   (final data collection date for primary outcome measure)
Percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01323153 on ClinicalTrials.gov Archive Site
  • Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in blood lipid levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Lipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of CV Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

This double-blind, randomized, placebo-controlled, multi-center study will evalu ate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the AC S. 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: dalcetrapib
    Oral doses of 600 mg once daily for 20 weeks
  • Drug: placebo
    Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
  • Experimental: 1
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2012
March 2012   (final data collection date for primary outcome measure)

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)
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Netherlands,   United Kingdom
 
NCT01323153
WC25501
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP