Phase 2 Completed N=130 Randomized Double-blind Treatment

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Heart Failure

Source: ClinicalTrials.gov NCT00655473 ↗

Enrolled (actual)

130

Serious AEs

30.0%

Results posted

Jan 2020

Primary outcomePrimary: Percent Change From Baseline in Mean Wall Thickness — 4.245; 6.679 Percent Change

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.

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	—	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.