A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

Tracking Information
First Submitted Date ICMJE	January 13, 2012
First Posted Date ICMJE	January 25, 2012
Last Update Posted Date	November 2, 2016
Study Start Date ICMJE	January 2012
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 24, 2012)	Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: approximately 4 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01516541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 24, 2012)	All cause mortality [ Time Frame: approximately 4 years ]; Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]; Change in blood lipid and lipoprotein levels [ Time Frame: from baseline to 12 months ]
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 With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Official Title ICMJE	A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).
Brief Summary	This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.
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	Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Intervention ICMJE	Other: Background care Guidelines-based medical care; Drug: Placebo Matching dalcetrapib placebo orally daily; Drug: dalcetrapib 600 mg orally daily
Study Arms	Experimental: Dalcetrapib Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care. Interventions: Other: Background care Drug: dalcetrapib; Placebo Comparator: Placebo Placebo orally daily, on a background of contemporary, guidelines-based medical care. Interventions: Other: Background care 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: December 12, 2012)	2220
Original Estimated Enrollment ICMJE; (submitted: January 24, 2012)	20000
Actual Study Completion Date	July 2012
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Adult patients, >/= 45 years of age; Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease; Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease; Receiving evidence-based medical and dietary management of dyslipidemia Exclusion Criteria: Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization; Uncontrolled hypertension; Uncontrolled diabetes; Concomitant treatment with any other drug raising HDL-C; Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
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	Australia, Canada, China, Czech Republic, Denmark, France, Hungary, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Removed Location Countries	Brazil, Bulgaria, Germany, India, Israel, Russian Federation, Taiwan, Ukraine
Administrative Information
NCT Number ICMJE	NCT01516541
Other Study ID Numbers ICMJE	NC25608; 2011-001891-21 ( EudraCT Number )
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