A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Phase 2
Completed
- Conditions
- Coronary Heart Disease
- Interventions
- Drug: placebo
- Registration Number
- NCT00400439
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
- patients who have completed treatment on study NC19453.
Exclusion Criteria
- any significant lymph node abnormalities at the end of study NC19453.
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 HDL-C Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
- Secondary Outcome Measures
Name Time Method Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1) Baseline and Week 24 (Week 48 from start of NC19453)