Status:
COMPLETED
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Atherosclerosis
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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
- Planned CABG or planned PCI or planned major non-cardiac surgery within study period
- No measurable Lp-PLA2 activity in plasma (\<10 nmol/min/mL) at screening
- Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
- Poorly controlled dyslipidemia (LDL-c \>=160 mg/dL) at screening
Exclusion
Key Trial Info
Start Date :
August 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2009
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00734032
Start Date
August 26 2008
End Date
January 16 2009
Last Update
January 12 2018
Active Locations (7)
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1
GSK Investigational Site
Fukuoka, Japan, 812-0025
2
GSK Investigational Site
Fukuoka, Japan, 818-0036
3
GSK Investigational Site
Fukuoka, Japan, 819-1102
4
GSK Investigational Site
Tokyo, Japan, 105-0004