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OpenTrials
Completed

NCT Number: NCT00353522

A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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

Berlin, Germany

Loading trial locations.

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;
  • body weight <125kg at visit 1.

Exclusion criteria

  • recent (within 3 weeks of screening) clinically significant coronary events;
  • history of statin-associated myopathy, or intolerance to statin;
  • history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
  • exposure to RO4607381 in past 12 months.

Treatment and study plan

Placebo

Drug

po daily for 24 weeks

Dalcetrapib

Drug

900mg po daily for 24 weeks

Primary outcomes

  1. Absolute Change From Baseline in HDL-C

    Time frame: Baseline and Week 24

  2. Percent Change From Baseline in HDL-C

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass

    Time frame: Baseline and Weeks 24

  2. Change in Mesenteric Lymph Nodes

    Time frame: Baseline and 48 Weeks

  3. Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)

    Time frame: Baseline and 48 Weeks

  4. Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity

    Time frame: Baseline and 48 Weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2006
Registry last updated
Jan 27, 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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