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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:

ClinicalTrials.gov Identifier:

NCT01516541

First Posted: January 25, 2012

Last Update Posted: November 2, 2016

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.

Information provided by (Responsible Party):

Hoffmann-La Roche

Tracking Information

First Submitted Date ^ICMJE

January 13, 2012

First Posted Date ^ICMJE

January 25, 2012

Last Update Posted Date

November 2, 2016

Start Date ^ICMJE

January 2012

Primary Completion Date

July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

2220

Completion Date

July 2012

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, Senior)

Accepts Healthy Volunteers

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

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