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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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.

Key facts

Study ID

NCT00353522

Run by

Hoffmann-La Roche

People needed

135

Starts

2006-07-01

Expected to finish

2008-10-01

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• CHD or CHD risk equivalent;
• body weight <125kg at visit 1.

You may not qualify if…

• 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.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Statesville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Berlin, Germany
• Study site — Bochum, Germany
• Study site — Dortmund, Germany
• Study site — Erlangen, Germany
• Study site — Freiburg im Breisgau, Germany
• Study site — Hamburg, Germany
• Study site — München, Germany

Full record on ClinicalTrials.gov

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