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

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Coronary Heart Disease

Interventions: Placebo, dalcetrapib

Countries: United States, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (17)

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