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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01516541

Enrollment

2220

Registered

2012-01-25

Start date

2012-01-31

Completion date

2012-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

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.

Interventions

OTHERBackground care

Guidelines-based medical care

DRUGPlacebo

Matching dalcetrapib placebo orally daily

DRUGdalcetrapib

600 mg orally daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)	approximately 4 years

Secondary

Measure	Time frame
All cause mortality	approximately 4 years
Safety: Incidence of adverse events	approximately 4 years
Change in blood lipid and lipoprotein levels	from baseline to 12 months

Countries

Australia, Canada, China, Czechia, Denmark, France, Hungary, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026