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A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

NCT00655538

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Coronary Heart Disease

Interventions: Placebo, dalcetrapib

Countries: Austria, France, Germany, Italy, Netherlands, Switzerland, United Kingdom

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 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;
* appropriately treated for accepted LDL-C level.

Exclusion Criteria:

* treatment with drugs raising HDL-C (eg niacin, fibrates);
* uncontrolled hypertension;
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* poorly controlled diabetes.

Locations (23)

Feldkirch, Austria
Paris, France
Bonn, Germany
Dortmund, Germany
Frankfurt, Germany
Mainz, Germany
Wuppertal, Germany
Pisa, Tuscany, Italy
Amsterdam, Netherlands
Breda, Netherlands
Eindhoven, Netherlands
Goes, Netherlands
Groningen, Netherlands
Hoorn, Netherlands
Leiderdorp, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Velp, Netherlands
Zoetermeer, Netherlands
Lugano, Switzerland
Zurich, Switzerland
Cardiff, United Kingdom