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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).

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).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017725-19-DE
Enrollment
900
Registered
2010-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease. MedDRA version: 12.1 Level: LLT Classification code 10011078 Term: Coronary artery disease

Interventions

Product Name: Dalcetrapib Product Code: RO4607381 Pharmaceutical Form: Film-coated tablet CAS Number: 211513-37-0 Current Sponsor code: RO4607381 Concentration unit: mg milligram(s) Concentration type

Sponsors

F. Hoffmann-La Roche AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the effect of dalcetrapib treatment for 2 years on atherosclerotic disease progression - as assessed by coronary intravascular ultrasound (IVUS) and carotid B-mode ultrasound - in patients with coronary artery disease (CAD). ;Secondary Objective: To evaluate the effect of dalcetrapib treatment for 2 years on atherosclerotic disease progression - as assessed by Coronary Angiography – in patients with coronary artery disease (CAD). To explore the effect of dalcetrapib on lipid metabolism and biomarkers of inflammation, oxidation and cardiovascular risk. To evaluate the long-term safety profile of dalcetrapib. ;Primary end point(s): There are two co-primary endpoints, for the assessment of atherosclerotic disease progression based on the two modes of measuring atherosclerotic plaque, they are defined for a patient as: Nominal change from baseline to study end in coronary percent atheroma volume (PAV) of the target coronary artery assessed by IVUS. Rate of change from baseline to study end in carotid intima-media thickness (CIMT) using B-mode ultrasound. Nominal changes from baseline to study end in coronary artery score and cumulative coronary stenosis score as assessed by quantitative coronary angiography.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026