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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353522
First received: July 17, 2006
Last updated: September 14, 2012
Last verified: September 2012
History of Changes

July 17, 2006
September 14, 2012
July 2006
October 2008   (final data collection date for primary outcome measure)
Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Percentage and absolute change from baseline to week 24 in HDL-C level.
Complete list of historical versions of study NCT00353522 on ClinicalTrials.gov Archive Site
  • Change from baseline in TC, TG, HDL-C, LDL-C, CETP mass and activity, ApoAl, ApoB [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Change from baseline in TC, TG, HDL-C, LDL-C, CETP mass and activity, ApoAI, ApOB. Safety: AEs, laboratory parameters. Change in mesenteric lymph nodes.
 
 
 
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
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

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.
 
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: dalceptrapib
    900mg po daily for 24 weeks
  • Drug: Placebo
    po daily for 24 weeks
  • Experimental: 1
    Intervention: Drug: dalceptrapib
  • 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
135
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00353522
NC19453
 
Hoffmann-La Roche
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

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