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Completed

NCT Number: NCT00658515

A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

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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

Almirante Brown, Argentina

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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;
  • recently hospitalized for ACS;
  • clinically stable;
  • receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion criteria

  • uncontrolled diabetes;
  • clinically unstable;
  • severe anemia;
  • uncontrolled hypertension;
  • concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Treatment and study plan

Dalcetrapib (RO4607381)

Drug

600mg po daily

Evidence-based medical care for Acute Coronary Syndrome

Drug

As prescribed

Placebo

Drug

po daily

Primary outcomes

  1. Incidence of Cardiovascular Mortality and Morbidity

    Time frame: From date of randomization to first event up to 48 months

    Number of cardiovascular events per patient per year

Secondary outcomes

  1. Composite Endpoint:All Cause Mortality

    Time frame: Throughout Study, up to 53 Months

  2. Change From Baseline for HDL Cholesterol

    Time frame: At 53 Months

  3. Adverse Events, Lab Parameters, Vital Signs, ECG

    Time frame: Throughout Study, up to 53 Months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2008
Registry last updated
Jan 3, 2020

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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