A study in adult patients with Cardiovascular disease or at elevated risk of having Cardiovascular disease to evaluate whether the study drug (Dalcetrapib) is able to reduce the risk of experiencing a cardiovascular event in the future such as a heart attack or a stroke by raising HDL cholesterol (also called good”cholesterol).

• Conditions: Patients with stable CHD, CHD risk equivalents (including PAD, cerebrovascular disease, and T2D), or at elevated risk for CV mortality and morbidity on the basis of multiple risk factors for CVD by raising HDL-C.; MedDRA version: 14.1Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001891-21-NL
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Adult patients =45 years of age with stable CHD, CHD risk equivalents or at elevated risk for CVD, receiving evidence-based medical therapy for dyslipidemia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8000

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 (eg niacin, fibrates, bile acid sequestrants) or drugs other than dalcetrapib.
. Previous treatment with compounds targeting CETP, e.g. torcetrapib, anacetrapib or dalcetrapib.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in adult patients with stable coronary heart disease (CHD), CHD risk equivalents or at elevated risk for cardiovascular disease (CVD);Secondary Objective: - To assess the long term safety and tolerability of dalcetrapib <br>;Primary end point(s): Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity).;Timepoint(s) of evaluation of this end point: End of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • All cause mortality.<br>• Change from baseline in blood lipids and lipoprotein levels.<br>• Adverse events, lab parameters, vital signs.<br>;Timepoint(s) of evaluation of this end point: End of the study