Phase 3
N=300
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01323153 ↗Enrolled (actual)
300
Serious AEs
7.7%
Results posted
Aug 2018
Primary outcome: Primary: Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment — 43.8; 10.1 Percentage raise in HDL-C Levels
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dalcetrapib (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment |
43.8; 10.1 | — |
| SECONDARY Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971 |
— | — |
| SECONDARY Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment |
— | — |
| SECONDARY Percent Change From Baseline in Blood Lipid Levels |
— | — |
| SECONDARY Percent Change From Baseline in Lipoprotein Levels |
— | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein Levels |
— | — |
| SECONDARY Safety: Incidence of Adverse Events |
— | — |
Summary
This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=45 years of age
- Patients admitted to the hospital for acute coronary syndrome (ACS)
- Patients receiving guideline-based medical and dietary management of dyslipidemia
Exclusion Criteria
- Symptomatic congestive heart failure (NYHA Class III or IV)
- Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
- Uncontrolled hypertension
- Uncontrolled diabetes
- Severe anemia
- Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
Data sourced from ClinicalTrials.gov (NCT01323153). 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.