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).

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). - dal-OUTCOMES 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001891-21-NL

Enrollment

20000

Registered

2011-12-20

Start date

2012-02-21

Completion date

Unknown

Last updated

2012-07-17

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

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: 14.1 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Dalcetrapib Product Code: RO460-7381/F51 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dalcetrapib CAS Number: 211513-37-0 Current Sponsor code: RO4607381 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 ;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	—

Measure

Time frame

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 ;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

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

Countries

Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Mexico, Netherlands, Poland, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026