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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400439
First Posted: November 16, 2006
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
November 15, 2006
November 16, 2006
July 29, 2016
January 2007
January 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) ]
  • Potential changes in mesenteric lymph nodes [ Time Frame: Throughout study ]
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 high density lipoprotein cholesterol (HDL-C), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1) [ Time Frame: Week 24 (Week 48 from start of NC19453) ]
  • Adverse events (AEs), laboratory parameters, vital signs [ Time Frame: Throughout study ]
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 patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: dalcetrapib (RO4607381)
    900mg po daily for 24 weeks
  • Drug: placebo
    po daily for 24 weeks
  • Experimental: dalcetrapib (RO4607381)
    Intervention: Drug: dalcetrapib (RO4607381)
  • Placebo Comparator: placebo
    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
January 2008
January 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Germany
 
NCT00400439
NC20716
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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