A Phase IIIB multicenter, double-blind, randomized, placebocontrolled study, evaluating the effect of treatment with dalcetrapib 600 mg on Atherosclerotic Disease as measured by I. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography II, Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD).
- Conditions
- A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease.MedDRA version: 12.1Level: LLTClassification code 10011078Term: Coronary artery disease
- Registration Number
- EUCTR2009-017725-19-DE
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
- Adult patients over the age of 18 years
- Angiographic evidence of coronary artery disease
- Ultrasound evidence of carotid artery disease
- Treated appropriately for dyslipidemia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Previous exposure to any CETP-inhibitor or -vaccine within the last 3 months before study start
- Clinically significant coronary events, transient ischemic attacks or cerebrovascular accident
- Severe anemia
- Uncontrolled hypertension
- Poorly controlled diabetes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method