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

Phase 2

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Placebo; Drug: dalcetrapib

• Registration Number: NCT00353522
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2016-06-28
• Disposition First Submitted QC: 2016-06-28
• Disposition First Posted: 2016-06-30
• Results First Submitted: 2019-07-17
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-24
• Last Update Submitted: 2020-01-24
• Results First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo po daily for 24 weeks
Dalcetrapib	dalcetrapib	Dalcetrapib 900mg po daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in HDL-C	Baseline and Week 24
Percent Change From Baseline in HDL-C	Baseline and Week 24

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity	Baseline and 48 Weeks
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)	Baseline and 48 Weeks
Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass	Baseline and Weeks 24
Change in Mesenteric Lymph Nodes	Baseline and 48 Weeks