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

• Status: Completed
• Trial end date: 2009-01-16
• Target enrollment: 0
• Participant gender: All

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 SB-480848.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Darapladib

Criteria

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