A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

Hoffmann-La Roche135 enrolled

Overview

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Coronary Heart Disease

Interventions

PlaceboDRUG

po daily for 24 weeks

dalcetrapibDRUG

900mg po daily for 24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, 18-75 years of age; * CHD or CHD risk equivalent; * body weight \<125kg at visit 1. Exclusion Criteria: * recent (within 3 weeks of screening) clinically significant coronary events; * history of statin-associated myopathy, or intolerance to statin; * history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening; * exposure to RO4607381 in past 12 months.

Locations (17)

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Absolute Change From Baseline in HDL-C

Time frame: Baseline and Week 24

Percent Change From Baseline in HDL-C

Time frame: Baseline and Week 24

Secondary Outcomes

Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass

Time frame: Baseline and Weeks 24

Change in Mesenteric Lymph Nodes

Time frame: Baseline and 48 Weeks

Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)

Time frame: Baseline and 48 Weeks

Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity

Time frame: Baseline and 48 Weeks

Data from ClinicalTrials.gov

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