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

NCT ID: NCT01323153

Last Updated: 2019-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dalcetrapib

Group Type EXPERIMENTAL

dalcetrapib

Intervention Type DRUG

Oral doses of 600 mg once daily for 20 weeks

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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dalcetrapib

Oral doses of 600 mg once daily for 20 weeks

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Pensacola, Florida, United States

Site Status

Pensacola, Florida, United States

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Saginaw, Michigan, United States

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Saint Cloud, Minnesota, United States

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Syracuse, New York, United States

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Rapid City, South Dakota, United States

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Chrudim, , Czechia

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České Budějovice, , Czechia

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Hradec Králové, , Czechia

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Jihlava, , Czechia

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Jindřichův Hradec, , Czechia

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Prague, , Czechia

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Semily, , Czechia

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Teplice, , Czechia

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Zlín, , Czechia

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Znojmo, , Czechia

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Beverwijk, , Netherlands

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Breda, , Netherlands

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Den Helder, , Netherlands

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Eindhoven, , Netherlands

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Gouda, , Netherlands

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Heerlen, , Netherlands

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Nieuwegein, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Sneek, , Netherlands

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Swansea, , United Kingdom

Site Status

Countries

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United States Czechia Netherlands United Kingdom

Other Identifiers

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WC25501

Identifier Type: -

Identifier Source: org_study_id

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