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Completed

NCT Number: NCT01323153

A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chrudim, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dalcetrapib

Drug

Oral doses of 600 mg once daily for 20 weeks

Placebo

Drug

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. 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

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

    Time frame: 20 weeks

  3. Percent Change From Baseline in Blood Lipid Levels

    Time frame: 20 weeks

  4. Percent Change From Baseline in Lipoprotein Levels

    Time frame: 20 weeks

  5. Percent Change From Baseline in Apolipoprotein Levels

    Time frame: 20 weeks

  6. Safety: Incidence of Adverse Events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2011
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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