Phase 2
N=130
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00655473 ↗Enrolled (actual)
130
Serious AEs
30.0%
Results posted
Jan 2020
Primary outcome: Primary: Percent Change From Baseline in Mean Wall Thickness — 4.245; 6.679 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dalcetrapib (RO4607381) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mean Wall Thickness |
4.245; 6.679 | — |
| PRIMARY Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. |
-0.188; -0.260 | — |
| SECONDARY Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance |
— | — |
| SECONDARY Change From Baseline in Vessel MR Determined Plaque Anatomy |
— | — |
| SECONDARY Blood Lipids,Lipoproteins |
— | — |
| SECONDARY Biomarkers |
— | — |
| SECONDARY CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure |
— | — |
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 positron emission tomography computed tomography (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.
Eligibility Criteria
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 cholesteryl ester transfer protein (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.
Data sourced from ClinicalTrials.gov (NCT00655473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.