A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00655473

Purpose

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which PET/CT and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Condition	Intervention	Phase
Coronary Heart Disease	Drug: RO4607381 Drug: Placebo	Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change from baseline of MRI plaque size/burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in target (plaque) to background (blood) ratio from an index vessel. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in vessel MR determined compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in vessel MR determined plaque anatomy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Blood lipids,lipoproteins [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
CHD, major coronary events, AEs, lab parameters, blood pressure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	181
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: RO4607381 600mg po daily for 24 months
2: Placebo Comparator	Drug: Placebo po daily for 24 months

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
CHD, including patients with other CHD risk factors;
treated appropriately for dyslipidemia;
clinically stable.

Exclusion Criteria:

previous exposure to any CETP inhibitor or vaccine;
recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
severe anemia;
uncontrolled hypertension;
poorly controlled diabetes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655473

Locations

United States, Florida

JACKSONVILLE, Florida, United States, 32216
United States, Michigan

ROYAL OAK, Michigan, United States, 48073
United States, Minnesota

MINNEAPOLIS, Minnesota, United States, 55455
United States, Missouri

Kansas City, Missouri, United States, 64111
United States, New York

New York, New York, United States, 10029
United States, North Carolina

STATESVILLE, North Carolina, United States, 28677
United States, Ohio

CINCINNATI, Ohio, United States, 45219

CINCINNATI, Ohio, United States, 45212

CLEVELAND, Ohio, United States, 44195
United States, Texas

HOUSTON, Texas, United States, 77030
United States, Washington

Seattle, Washington, United States, 98108
Canada, Quebec

MONTREAL, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NC21153
Study First Received:	March 28, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00655473 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Disease Progression
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009