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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01323153

First received: March 24, 2011

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2011

Last Updated Date

September 1, 2016

Start Date ^ICMJE

March 2011

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01323153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in blood lipid levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in Lipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in Apolipoprotein levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Dalcetrapib
Intervention: Drug: dalcetrapib
Placebo Comparator: Placebo
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

45 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Czech Republic, Netherlands, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01323153

Other Study ID Numbers ^ICMJE

WC25501

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

September 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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