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

Roche

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: Dalcetrapib (RO4607381); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655473

NC21153

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Dalcetrapib (RO4607381)

Experimental group

Treatment:

Drug: Dalcetrapib (RO4607381)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo