A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00655538
First received: March 28, 2008
Last updated: October 20, 2014
Last verified: October 2014

March 28, 2008
October 20, 2014
February 2008
May 2010   (final data collection date for primary outcome measure)
  • Change from baseline in % flow mediated dilatation (FMD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655538 on ClinicalTrials.gov Archive Site
  • Change from baseline in % FMD [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Blood lipids, lipoproteins [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • CETP mass and activity [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • AEs, lab parameters, vital signs, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

This study will assess the safety, tolerability and efficacy of RO4607381 in pat ients with coronary heart disease (CHD) or CHD risk equivalents. Patients will b e randomized to receive either RO4607381 600mg po daily or placebo po daily. End othelial function will be measured by flow mediated dilatation and blood pressur e monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: Placebo
    po daily for 36 weeks
  • Drug: dalcetrapib
    600mg po daily for 36 weeks
  • 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
476
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • CHD or CHD risk equivalent;
  • appropriately treated for accepted LDL-C level.

Exclusion Criteria:

  • treatment with drugs raising HDL-C (eg niacin, fibrates);
  • uncontrolled hypertension;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • poorly controlled diabetes.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   France,   United Kingdom,   Italy,   Netherlands,   Switzerland,   Austria
 
NCT00655538
BC21144, 2007-003406-10
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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