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

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	8/3/2016
Start Date:	July 2006
End Date:	October 2008

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

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.

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.

We found this trial at

sites

Clinical Trial Facility in Statesville North Carolina

Statesville, North Carolina 28677

from

Statesville, NC