Phase 2
N=135
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00353522 ↗Enrolled (actual)
135
Serious AEs
12.6%
Results posted
Jan 2020
Primary outcome: Primary: Absolute Change From Baseline in HDL-C — 12.76; 0.50 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); dalcetrapib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in HDL-C |
12.76; 0.50 | — |
| PRIMARY Percent Change From Baseline in HDL-C |
33.40; 3.59 | — |
| SECONDARY Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass |
86.45; -4.93 | — |
| SECONDARY Change in Mesenteric Lymph Nodes |
4; 11; 6; 18 | — |
| SECONDARY Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB) |
10.17; 2.67; 0.94; 4.11; 33.76; 3.69 | — |
| SECONDARY Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity |
-56.5; -5.69 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00353522). 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.