Phase 2
Completed N=107
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Source: ClinicalTrials.gov NCT00734032 ↗Enrolled (actual)
107
Serious AEs
0.9%
Results posted
Jan 2018
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.