A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

Coronary Heart Disease Clinical Trial

Official title:

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323153
• Other study ID #: WC25501
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• dalcetrapib
Oral doses of 600 mg once daily for 20 weeks
• placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Czechia,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment		4 weeks
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		4 weeks
Secondary	Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment		20 weeks
Secondary	Percent Change From Baseline in Blood Lipid Levels		20 weeks
Secondary	Percent Change From Baseline in Lipoprotein Levels		20 weeks
Secondary	Percent Change From Baseline in Apolipoprotein Levels		20 weeks
Secondary	Safety: Incidence of Adverse Events		24 weeks