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

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dalcetrapib

placebo

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dalcetrapib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment

Secondary Outcome Measures

Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971

Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment

Percent Change From Baseline in Blood Lipid Levels

Percent Change From Baseline in Lipoprotein Levels

Percent Change From Baseline in Apolipoprotein Levels

Safety: Incidence of Adverse Events

Full Information

NCT ID

NCT01323153

First Posted

March 24, 2011

Last Updated

July 17, 2019

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01323153

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dalcetrapib

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

dalcetrapib

Intervention Description

Oral doses of 600 mg once daily for 20 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Title

Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment

Time Frame

20 weeks

Title

Percent Change From Baseline in Blood Lipid Levels

Time Frame

20 weeks

Title

Percent Change From Baseline in Lipoprotein Levels

Time Frame

20 weeks

Title

Percent Change From Baseline in Apolipoprotein Levels

Time Frame

20 weeks

Title

Safety: Incidence of Adverse Events

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32501

Country

United States

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48602

Country

United States

City

Saint Cloud

State/Province

Minnesota

ZIP/Postal Code

56303

Country

United States

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

City

Ceske Budejovice

ZIP/Postal Code

370 87

Country

Czechia

City

Chrudim

ZIP/Postal Code

537 25

Country

Czechia

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

City

Jihlava

ZIP/Postal Code

586 01

Country

Czechia

City

Jindrichuv Hradec

ZIP/Postal Code

377 38

Country

Czechia

City

Praha

ZIP/Postal Code

100 34

Country

Czechia

City

Semily

ZIP/Postal Code

513 31

Country

Czechia

City

Teplice

ZIP/Postal Code

415 01

Country

Czechia

City

Zlin

ZIP/Postal Code

762 75

Country

Czechia

City

Znojmo

ZIP/Postal Code

669 02

Country

Czechia

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

City

Beverwijk

ZIP/Postal Code

1942 LE

Country

Netherlands

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

City

Den Helder

ZIP/Postal Code

1782GZ

Country

Netherlands

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

City

Gouda

ZIP/Postal Code

2803 HH

Country

Netherlands

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

City

Sneek

ZIP/Postal Code

8601 ZK

Country

Netherlands

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

City

Glasgow

ZIP/Postal Code

G31 2ER

Country

United Kingdom

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

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

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