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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis

Treatments: Drug: SB480848 160mg EC Tablet; Drug: SB480848 80mg EC Tablet; Drug: SB480848 40mg EC Tablet; Drug: SB480848 Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734032

LPL110118

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 4 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Matched Placebo

Treatment:

Drug: SB480848 Placebo Tablet

SB480848 40mg Group

Experimental group

Description:

SB480848 40mg/day

Treatment:

Drug: SB480848 40mg EC Tablet

SB480848 80mg Group

Experimental group

Description:

SB480848 80mg/day

Treatment:

Drug: SB480848 80mg EC Tablet

SB480848 160mg Group

Experimental group

Description:

SB480848 160mg/day

Treatment:

Drug: SB480848 160mg EC Tablet