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OpenTrials
Completed

NCT Number: NCT00655538

A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 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

Feldkirch, Austria

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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 or CHD risk equivalent;
  • appropriately treated for accepted LDL-C level.

Exclusion criteria

  • treatment with drugs raising HDL-C (eg niacin, fibrates);
  • uncontrolled hypertension;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • poorly controlled diabetes.

Treatment and study plan

Placebo

Drug

po daily for 36 weeks

Dalcetrapib

Drug

600mg po daily for 36 weeks

Primary outcomes

  1. Change From Baseline in % Flow Mediated Dilatation (FMD)

    Time frame: Baseline and 12 weeks

  2. Change From Baseline in Mean BP, Measured by BP Monitoring

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. Change From Baseline in % FMD

    Time frame: baseline and 36 weeks

  2. Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB

    Time frame: Baseline to 36 weeks

  3. CETP Activity

    Time frame: Up to 36 weeks

  4. Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9

    Time frame: Baseline and 36 weeks

  5. Change From Baseline in Mean BP, Measured by BP Monitoring

    Time frame: Up to 36 weeks

  6. Percent Change CETP Mass

    Time frame: baseline to 36 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 10, 2008
Registry last updated
Jan 2, 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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