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OpenTrials
Completed

NCT Number: NCT00655473

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montreal, Quebec, Canada

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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, 18-75 years of age;
  • CHD, including patients with other CHD risk factors;
  • treated appropriately for dyslipidemia;
  • clinically stable.

Exclusion criteria

  • previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • uncontrolled hypertension;
  • poorly controlled diabetes.

Treatment and study plan

Dalcetrapib (RO4607381)

Drug

600mg po daily for 24 months

Placebo

Drug

po daily for 24 months

Primary outcomes

  1. Percent Change From Baseline in Mean Wall Thickness

    Time frame: 24 months

  2. Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.

    Time frame: 6 months

Secondary outcomes

  1. Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance

    Time frame: 6 months

  2. Change From Baseline in Vessel MR Determined Plaque Anatomy

    Time frame: Up to 24 months

  3. Blood Lipids,Lipoproteins

    Time frame: Throughout study

  4. Biomarkers

    Time frame: Up to 24 months

  5. CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 10, 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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