Phase 2
N=476
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00655538 ↗Enrolled (actual)
476
Serious AEs
5.5%
Results posted
Jan 2020
Primary outcome: Primary: Change From Baseline in % Flow Mediated Dilatation (FMD) — 0.09; 0.32 %FMD
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
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in % Flow Mediated Dilatation (FMD) |
0.09; 0.32 | — |
| PRIMARY Change From Baseline in Mean BP, Measured by BP Monitoring |
1.93; 1.17 | — |
| SECONDARY Change From Baseline in % FMD |
10.50; 20.13 | — |
| SECONDARY Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB |
30.70; -0.14; 4.43; 8.72; 8.66; 5.90 | — |
| SECONDARY CETP Activity |
-48.66; 7.37 | — |
| SECONDARY Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9 |
-1.83; 0.24; 6.01; 6.08; 1.05; 2.01 | — |
| SECONDARY Change From Baseline in Mean BP, Measured by BP Monitoring |
1.93; 1.17 | — |
| SECONDARY Percent Change CETP Mass |
94.19; 5.17 | — |
Summary
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-75 years of age;
- CHD or CHD risk equivalent;
- appropriately treated for accepted LDL-C level.
Exclusion Criteria
- treatment with drugs raising HDL-C (eg niacin, fibrates);
- uncontrolled hypertension;
- recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
- severe anemia;
- poorly controlled diabetes.
Data sourced from ClinicalTrials.gov (NCT00655538). 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.