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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00655473
First received: March 28, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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 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 Intervention Phase
Coronary Heart Disease
 Drug: dalcetrapib
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from baseline of MRI plaque size/burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in target (plaque) to background (blood) ratio from an index vessel. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in vessel MR determined compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in vessel MR determined plaque anatomy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Blood lipids,lipoproteins [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • CHD, major coronary events, AEs, lab parameters, blood pressure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: March 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
600mg po daily for 24 months
Placebo Comparator: 2 Drug: Placebo
po daily for 24 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655473

Locations
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, 45212
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received: March 28, 2008
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Plaque, Atherosclerotic
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Pathological Conditions, Anatomical
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013