A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353522

Purpose

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-Week Period in Patients With CHD or a CHD Risk Equivalent

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in TC, TG, HDL-C, LDL-C, CETP mass and activity, ApoAl, ApoB [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	135
Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Experimental	Drug: RO4607381 900mg po daily for 24 weeks
2: Placebo Comparator	Drug: Placebo po daily for 24 weeks

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 or CHD risk equivalent;
body weight <125kg at visit 1.

Exclusion Criteria:

recent (within 3 weeks of screening) clinically significant coronary events;
history of statin-associated myopathy, or intolerance to statin;
history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
exposure to RO4607381 in past 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353522

Locations

United States, Illinois

CHICAGO, Illinois, United States, 60610
United States, Indiana

INDIANAPOLIS, Indiana, United States, 46260
United States, Iowa

IOWA CITY, Iowa, United States, 52242
United States, Kentucky

LOUISVILLE, Kentucky, United States, 40213
United States, Maryland

BETHESDA, Maryland, United States, 20817
United States, Minnesota

MINNEAPOLIS, Minnesota, United States, 55455
United States, North Carolina

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

CINCINNATI, Ohio, United States, 45212

CINCINNATI, Ohio, United States, 45219
United States, Utah

SALT LAKE CITY, Utah, United States, 84132
Germany

MÜNCHEN, Germany, 80336

BERLIN, Germany, 10707

DORTMUND, Germany, 44137

ERLANGEN, Germany, 91054

BOCHUM, Germany, 44791

FREIBURG, Germany, 79106

HAMBURG, Germany, 20249

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:	NC19453
Study First Received:	July 17, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00353522 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 03, 2009