A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Roche

Status and phase: Completed; Phase 3

Conditions: Coronary Heart Disease

Treatments: Drug: Dalcetrapib (RO4607381); Drug: Evidence-based medical care for Acute Coronary Syndrome; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658515

NC20971

2007-005103-18

Details and patient eligibility

About

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Enrollment: 15,871 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=45 years of age;
• recently hospitalized for ACS;
• clinically stable;
• receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion criteria

• uncontrolled diabetes;
• clinically unstable;
• severe anemia;
• uncontrolled hypertension;
• concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15,871 participants in 2 patient groups, including a placebo group

Dalcetrapib (RO4607381)

Experimental group

Treatment:

Drug: Evidence-based medical care for Acute Coronary Syndrome

Drug: Dalcetrapib (RO4607381)

Placebo

Placebo Comparator group

Treatment:

Drug: Evidence-based medical care for Acute Coronary Syndrome

Drug: Placebo