A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400439
First received: November 15, 2006
Last updated: October 20, 2014
Last verified: October 2014

November 15, 2006
October 20, 2014
January 2007
April 2008   (final data collection date for primary outcome measure)
  • Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 (Week 48 from start of NC19453) ] [ Designated as safety issue: No ]
  • Potential changes in mesenteric lymph nodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Percentage and absolute change from baseline at week 48 in HDL-C level. Safety: Potential changes in mesenteric lymph nodes over time.
Complete list of historical versions of study NCT00400439 on ClinicalTrials.gov Archive Site
  • Change from baseline in HDL-C, TC, LDL-C, TG, ApoB and ApoAl [ Time Frame: Week 24 (Week 48 from start of NC19453) ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Change from baseline in HDL-C, TC, LDL-C, TG, ApoB and ApoAI. Safety: AEs, laboratory tests, vital signs.
Not Provided
Not Provided
 
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

This 2 arm study will assess the long term safety and efficacy of RO4607381 in p atients with coronary heart disease or a CHD risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will cont inue on the treatment they were originally assigned to ie RO4607381 (900mg po) o r placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The antici pated time on study treatment is 6 months post study NC19453, and the target sam ple size is approximately 100 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 24 weeks
  • Drug: dalcetrapib
    900mg po daily for 24 weeks
  • Experimental: 1
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who have completed treatment on study NC19453.

Exclusion Criteria:

  • any significant lymph node abnormalities at the end of study NC19453.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00400439
NC20716
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