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A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome | Clinical Trials | Clareo Health

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

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

NCT00658515•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

ALL

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).

Locations (1089)

Birmingham, Alabama, United States

Mobile, Alabama, United States

Tuscaloosa, Alabama, United States

Lake Havasu City, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Key Dates

Start Date

April 1, 2008

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

January 3, 2020

Enrollment

15,871

ACTUAL participants

Conditions

Coronary Heart Disease

Interventions

Dalcetrapib (RO4607381)

DRUG

Evidence-based medical care for Acute Coronary Syndrome

DRUG

Placebo

DRUG

Clinical Outcomes of Patients With Coronary Artery Disease

NCT06216847

Coronary Heart Disease (CHD)

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RECRUITING

Village-Based Management of Chronic Cardiovascular Disease in Qu Jiang Elderly Population Registry: The BOUQUET Cohort Study

NCT07149688

Atrial Fibrillation (AF)Hypertension+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Outcomes of Patients With Coronary Artery Disease

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