Phase 3
N=15,871
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00658515 ↗Enrolled (actual)
15,871
Serious AEs
21.3%
Results posted
Jan 2020
Primary outcome: Primary: Incidence of Cardiovascular Mortality and Morbidity — 0.034050; 0.032759 Event per Patient Years of Followup
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dalcetrapib (RO4607381) (Drug); Evidence-based medical care for Acute Coronary Syndrome (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Cardiovascular Mortality and Morbidity |
0.034050; 0.032759 | — |
| SECONDARY Composite Endpoint:All Cause Mortality |
226; 229 | — |
| SECONDARY Change From Baseline for HDL Cholesterol |
44.96; 15.60 | — |
| SECONDARY Adverse Events, Lab Parameters, Vital Signs, ECG |
— | — |
Summary
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=45 years of age;
- recently hospitalized for ACS;
- clinically stable;
- receiving evidence-based medical and dietary management of dyslipidemia.
Exclusion Criteria
- uncontrolled diabetes;
- clinically unstable;
- severe anemia;
- uncontrolled hypertension;
- concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
Data sourced from ClinicalTrials.gov (NCT00658515). 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.