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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01516541
First received: January 13, 2012
Last updated: October 20, 2014
Last verified: October 2014

January 13, 2012
October 20, 2014
January 2012
July 2012   (final data collection date for primary outcome measure)
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516541 on ClinicalTrials.gov Archive Site
  • All cause mortality [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Change in blood lipid and lipoprotein levels [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
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).

This multicenter, randomized, double-blind, placebo-controlled, parallel-group s tudy will evaluate the potential of dalcetrapib to reduce cardiovascular morbidi ty and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patien ts will be randomized to receive either dalcetrapib 600 mg orally daily or place bo orally daily, on a background of contemporary, guidelines-based medical care.

Anticipated time on study treatment is 4 years.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
  • Other: Background care
    Guidelines-based medical care
  • Drug: Placebo
    Matching dalcetrapib placebo orally daily
  • Drug: dalcetrapib
    600 mg orally daily
  • Experimental: Dalcetrapib
    Interventions:
    • Other: Background care
    • Drug: dalcetrapib
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Background care
    • 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
2220
July 2012
July 2012   (final data collection date for primary outcome measure)

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 CETP
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Australia,   Canada,   China,   Czech Republic,   Denmark,   France,   Hungary,   Mexico,   Netherlands,   Poland,   Spain
 
NCT01516541
NC25608, 2011-001891-21
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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