Trial information
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Status: Recruiting
Protocol number: BC21144
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, placebo-controlled study of the safety, tolerability and effect on endothelial function, as measured by flow mediated dilatation, of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents.
Brief summary: 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. Target sample size is 450.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Coronary Heart Disease
Intervention type: Drug
Intervention name: RO4607381
Primary outcome: 1. Change from baseline in % flow mediated dilatation (FMD) Time frame: 12 weeks
2. Change from baseline in mean BP, measured by BP monitoring Time frame: 4 weeks
Key secondary outcomes: 1. Change from baseline in % FMD Time frame: 36 weeks
2. Blood lipids, lipoproteins Time frame: Throughout study
3. CETP mass and activity Time frame: Up to 36 weeks
4. Biomarkers Time frame: Up to 36 weeks
5. Change from baseline in mean BP, measured by BP monitoring Time frame: Up to 36 weeks
6. AEs, lab parameters, vital signs, ECG Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2008
Trial registration date: 03/28/2008
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
France
Germany
- Bonn
- Dortmund
- Frankfurt
- Mainz
- Wuppertal
Italy
Netherlands
- Amsterdam
- Breda
- Eindhoven
- Goes
- Groningen
- Hoorn
- Leiden
- Nijmegen
- Rotterdam
- Utrecht
- Velp
- Zoetermeer
Switzerland
United Kingdom
