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

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.
ClinicalTrials.gov Identifier: NCT00655473
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Dalcetrapib (RO4607381) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dalcetrapib (RO4607381) Drug: Dalcetrapib (RO4607381)
600mg po daily for 24 months
Placebo Comparator: Placebo Drug: Placebo
po daily for 24 months

Primary Outcome Measures :
  1. Change from baseline of MRI plaque size/burden [ Time Frame: 12 months ]
  2. Change from baseline in target (plaque) to background (blood) ratio from an index vessel. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00655473

United States, Florida
Jacksonville, Florida, United States, 32216
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New York
New York, New York, United States, 10029
United States, North Carolina
Statesville, North Carolina, United States, 28677
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
Cleveland, Ohio, United States, 44195
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98108
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00655473     History of Changes
Other Study ID Numbers: NC21153
First Posted: April 10, 2008    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
Plaque, Atherosclerotic
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents