A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 135
- Primary Endpoint
- Absolute Change From Baseline in HDL-C
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dalcetrapib
Dalcetrapib 900mg po daily for 24 weeks
Intervention: dalcetrapib (Drug)
Placebo
Placebo po daily for 24 weeks
Intervention: Placebo (Drug)
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
- 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)