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

Phase 2

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Placebo; Drug: Dalcetrapib (RO4607381)

• Registration Number: NCT00655473
• Lead Sponsor: Hoffmann-La Roche

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Results First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• adult patients, 18-75 years of age;
• CHD, including patients with other CHD risk factors;
• treated appropriately for dyslipidemia;
• clinically stable.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dalcetrapib (RO4607381)	Dalcetrapib (RO4607381)	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Wall Thickness	24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.	6 months

Secondary Outcome Measures

Name	Time	Method
Blood Lipids,Lipoproteins	Throughout study
Biomarkers	Up to 24 months
Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance	6 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure	Throughout study
Change From Baseline in Vessel MR Determined Plaque Anatomy	Up to 24 months