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: August 4, 2014
Last verified: August 2014

March 28, 2008
August 4, 2014
March 2008
November 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00655473 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
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

This study will assess the effect of RO4607381, compared to placebo, on atherosc lerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which PET/C T and MRI will be conducted, patients will be randomized to receive either RO460 7381 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: dalcetrapib
    600mg po daily for 24 months
  • Drug: Placebo
    po daily for 24 months
  • Experimental: 1
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00655473
NC21153
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP