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

Phase 3

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Dalcetrapib (RO4607381); Drug: Evidence-based medical care for Acute Coronary Syndrome; Drug: Placebo

• Registration Number: NCT00658515
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-03-28
• Study Start: 2008-04
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-15
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Disposition First Submitted: 2016-08-09
• Disposition First Submitted QC: 2016-09-01
• Disposition First Posted: 2016-09-02
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Results First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15871

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dalcetrapib (RO4607381)	Dalcetrapib (RO4607381)	-
Dalcetrapib (RO4607381)	Evidence-based medical care for Acute Coronary Syndrome	-
Placebo	Evidence-based medical care for Acute Coronary Syndrome	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Cardiovascular Mortality and Morbidity	From date of randomization to first event up to 48 months	Number of cardiovascular events per patient per year

Secondary Outcome Measures

Name	Time	Method
Composite Endpoint:All Cause Mortality	Throughout Study, up to 53 Months
Change From Baseline for HDL Cholesterol	At 53 Months
Adverse Events, Lab Parameters, Vital Signs, ECG	Throughout Study, up to 53 Months