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

Tracking Information
First Submitted Date ICMJE	March 24, 2011
First Posted Date ICMJE	March 25, 2011
Last Update Posted Date	November 2, 2016
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, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Czech Republic, Netherlands, United Kingdom, United States
Removed Location Countries
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	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP