Phase 2 N=107 Randomized Double-blind Treatment

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

Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00734032 ↗

Enrolled (actual)

107

Serious AEs

0.9%

Results posted

Jan 2018

Primary outcome: Primary: Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity — 0.961; 0.494; 0.404; 0.313 Log(millimole per milliliter per minute) — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SB480848 40mg EC Tablet (Drug); SB480848 80mg EC Tablet (Drug); SB480848 160mg EC Tablet (Drug); SB480848 Placebo Tablet (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity	0.961; 0.494; 0.404; 0.313	<.001 sig
SECONDARY Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time	-4.06; -48.25; -55.83; -66.03; -1.96; -49.05	—
SECONDARY Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up	0.957; 0.495; 0.430; 0.332; 0.977; 0.499	—

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.

Eligibility 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

Recent (i.e., =160 mg/dL) at screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.