Phase 2
N=77
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00400439 ↗Enrolled (actual)
77
Serious AEs
—
Results posted
Jan 2020
Primary outcome: Primary: Percent Change From Baseline in HDL-C — 33.76; 3.69 Percentage Change of HDL-C
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dalcetrapib (RO4607381) (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in HDL-C |
33.76; 3.69 | — |
| SECONDARY 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) |
37.29; 2.98; 16.60; -0.96; 7.54; 2.16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients who have completed treatment on study NC19453.
Exclusion Criteria
- any significant lymph node abnormalities at the end of study NC19453.
Data sourced from ClinicalTrials.gov (NCT00400439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.