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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01323153
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 25, 2011
Results First Submitted Date July 6, 2018
Results First Posted Date August 6, 2018
Last Update Posted Date August 6, 2018
Study Start Date  ICMJE March 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01323153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • 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 ]
  • Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment [ Time Frame: 20 weeks ]
  • Percent Change From Baseline in Blood Lipid Levels [ Time Frame: 20 weeks ]
  • Percent Change From Baseline in Lipoprotein Levels [ Time Frame: 20 weeks ]
  • Percent Change From Baseline in Apolipoprotein Levels [ Time Frame: 20 weeks ]
  • Safety: Incidence of Adverse Events [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
Official Title  ICMJE 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 Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • 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
Study Arms
  • Experimental: Dalcetrapib
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2011)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Netherlands,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01323153
Other Study ID Numbers  ICMJE WC25501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2018

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