Trial information
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Status: Recruiting
Protocol number: NC21153
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, placebo-controlled study of the effect of RO4607381 on progression or regression of atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors
Brief summary: This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which PET/CT and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals. Target sample size is 130.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Efficacy study
Condition: Coronary Heart Disease
Intervention type: Drug
Intervention name: RO4607381
Primary outcome: 1. Change from baseline of MRI plaque size/burden Time frame: 12 months
2. Change from baseline in target (plaque) to background (blood) ratio from an index vessel. Time frame: 6 months
Key secondary outcomes: 1. Change from baseline in vessel MR determined compliance Time frame: 6 months
2. Change from baseline in vessel MR determined plaque anatomy Time frame: Up to 24 months
3. Blood lipids,lipoproteins Time frame: Throughout study
4. Biomarkers Time frame: Up to 24 months
5. CHD, major coronary events, AEs, lab parameters, blood pressure Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- CHD, including patients with other CHD risk factors;
- treated appropriately for dyslipidemia;
- clinically stable.
Exclusion criteria:
- previous exposure to any CETP inhibitor or vaccine;
- recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
- severe anemia;
- uncontrolled hypertension;
- poorly controlled diabetes.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 03/28/2008
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Canada
United States
- Jacksonville, FL
- Boston, MA
- Royal Oak, MI
- Minneapolis, MN
- Kansas City, MO
- New York, NY
- Statesville, NC
- Cincinnati, OH
- Cleveland, OH
- Houston, TX
- Seattle, WA
