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

July 17, 2019 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ceske Budejovice, Czechia, 370 87
      • Chrudim, Czechia, 537 25
      • Hradec Kralove, Czechia, 500 05
      • Jihlava, Czechia, 586 01
      • Jindrichuv Hradec, Czechia, 377 38
      • Praha, Czechia, 100 34
      • Semily, Czechia, 513 31
      • Teplice, Czechia, 415 01
      • Zlin, Czechia, 762 75
      • Znojmo, Czechia, 669 02
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
      • Arnhem, Netherlands, 6815 AD
      • Beverwijk, Netherlands, 1942 LE
      • Breda, Netherlands, 4818 CK
      • Den Helder, Netherlands, 1782GZ
      • Eindhoven, Netherlands, 5623 EJ
      • Gouda, Netherlands, 2803 HH
      • Heerlen, Netherlands, 6419 PC
      • Nieuwegein, Netherlands, 3435 CM
      • Nijmegen, Netherlands, 6532 SZ
      • Rotterdam, Netherlands, 3045 PM
      • Sneek, Netherlands, 8601 ZK
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
      • Glasgow, United Kingdom, G31 2ER
      • London, United Kingdom, EC1M 6BQ
      • Stoke-on-Trent, United Kingdom, ST4 6QG
      • Swansea, United Kingdom, SA6 6NL
  • United States
    • Florida
      • Pensacola, Florida, United States, 32504
      • Pensacola, Florida, United States, 32501
    • Michigan
      • Saginaw, Michigan, United States, 48602
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
    • New York
      • Syracuse, New York, United States, 13210
    • South Dakota
      • Rapid City, South Dakota, United States, 57701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
EXPERIMENTAL: Dalcetrapib
Drug: dalcetrapib
Oral doses of 600 mg once daily for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (ESTIMATE)

March 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WC25501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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