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

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. Identifier: NCT01516541
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD) Other: Background care Drug: Placebo Drug: dalcetrapib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dalcetrapib
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Other: Background care
Guidelines-based medical care

Drug: dalcetrapib
600 mg orally daily

Placebo Comparator: Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Other: Background care
Guidelines-based medical care

Drug: Placebo
Matching dalcetrapib placebo orally daily

Primary Outcome Measures :
  1. Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: approximately 4 years ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]
  3. Change in blood lipid and lipoprotein levels [ Time Frame: from baseline to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516541

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Anaheim, California, United States, 92801
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Liverpool, United Kingdom, L22 0LG
Manchester, United Kingdom, M15 6SX
Reading, United Kingdom, RG2 0TG
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01516541     History of Changes
Other Study ID Numbers: NC25608
2011-001891-21 ( EudraCT Number )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents