A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00658515

Purpose

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 500+ individuals.

Condition	Intervention	Phase
Coronary Heart Disease	Drug: RO4607381 Drug: Placebo Drug: Evidence-based medical care for Acute Coronary Syndrome	Phase III

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite endpoint:all cause mortality [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Adverse events, lab parameters, vital signs, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	15600
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2012

Arms	Assigned Interventions
1: Experimental	Drug: RO4607381 600mg po daily Drug: Evidence-based medical care for Acute Coronary Syndrome As prescribed
2: Placebo Comparator	Drug: Placebo po daily Drug: Evidence-based medical care for Acute Coronary Syndrome As prescribed

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658515

Contacts

Contact: Please reference Study ID Number: PDO_NC20971	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 1070 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NC20971, 2007-005103-18
Study First Received:	March 28, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00658515
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009