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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353522
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Placebo Drug: dalcetrapib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dalcetrapib
Dalcetrapib 900mg po daily for 24 weeks
Drug: dalcetrapib
900mg po daily for 24 weeks

Placebo Comparator: Placebo
Placebo po daily for 24 weeks
Drug: Placebo
po daily for 24 weeks

Primary Outcome Measures :
  1. Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in total cholesterol (TC), triglycerides (TG), HDL-C, LDL-C, cholesterol ester transfer protein (CETP) mass and activity, apolipoproteins A1 (ApoA1), apolipoproteins B (ApoB) [ Time Frame: Weeks 24 ]
  2. Adverse events (AEs), laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353522

United States, Illinois
Chicago, Illinois, United States, 60610
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Statesville, North Carolina, United States, 28677
United States, Ohio
Cincinnati, Ohio, United States, 45212
Cincinnati, Ohio, United States, 45219
United States, Utah
Salt Lake City, Utah, United States, 84132
Berlin, Germany, 10707
Bochum, Germany, 06097
Dortmund, Germany, 44137
Erlangen, Germany, 91054
Freiburg, Germany, 79106
Hamburg, Germany, 20249
München, Germany, 80336
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00353522     History of Changes
Other Study ID Numbers: NC19453
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents