A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00734032
First received: August 12, 2008
Last updated: June 21, 2012
Last verified: May 2012

August 12, 2008
June 21, 2012
August 2008
January 2009   (final data collection date for primary outcome measure)
Change from baseline to week 4 in plasma Lp-PLA2 activity [ Time Frame: 4 weeks ]
Change from baseline to week 4 in plasma Lp-PLA2 activity
Complete list of historical versions of study NCT00734032 on ClinicalTrials.gov Archive Site
•Percent inhibition of Lp-PLA2 activity in plasma at week 4•Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline [ Time Frame: 4 weeks ]
•Percent inhibition of Lp-PLA2 activity in plasma at week 4 •Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline
Not Provided
Not Provided
 
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients - A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety -

The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyslipidaemia
  • Atherosclerosis
  • Drug: SB480848 40mg EC Tablet
    1 tablet once a day
    Other Name: Darapladib
  • Drug: SB480848 80mg EC Tablet
    1 tablet once a day
  • Drug: SB480848 160mg EC Tablet
    1 tablet once a day
  • Drug: SB480848 Placebo Tablet
    1 tablet once a day
  • Placebo Comparator: Placebo Group
    Matched Placebo
    Intervention: Drug: SB480848 Placebo Tablet
  • Experimental: SB480848 40mg Group
    SB480848 40mg/day
    Intervention: Drug: SB480848 40mg EC Tablet
  • Experimental: SB480848 80mg Group
    SB480848 80mg/day
    Intervention: Drug: SB480848 80mg EC Tablet
  • Experimental: SB480848 160mg Group
    SB480848 160mg/day
    Intervention: Drug: SB480848 160mg EC Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization

Exclusion criteria:

  1. Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as:

    A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest

  2. Planned CABG or planned PCI or planned major non-cardiac surgery within study period
  3. No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
  4. Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
  5. Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00734032
LPL110118
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

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