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

Phase 2

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: SB480848 Placebo Tablet; Drug: SB480848 40mg EC Tablet; Drug: SB480848 80mg EC Tablet; Drug: SB480848 160mg EC Tablet

• Registration Number: NCT00734032
• Lead Sponsor: GlaxoSmithKline

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 SB-480848.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Study Start: 2008-08-26
• Primary Completion: 2009-01-16
• Study Completion: 2009-01-16
• Disposition First Submitted: 2010-02-05
• Disposition First Submitted QC: 2010-02-05
• Disposition First Posted: 2010-02-10
• Results First Submitted: 2017-07-18
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-10
• Last Update Submitted: 2018-01-10
• Results First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	SB480848 Placebo Tablet	Matched Placebo
SB480848 40mg Group	SB480848 40mg EC Tablet	SB480848 40mg/day
SB480848 80mg Group	SB480848 80mg EC Tablet	SB480848 80mg/day
SB480848 160mg Group	SB480848 160mg EC Tablet	SB480848 160mg/day

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity	Baseline (Week 0, Visit 2) and Week 4	Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value \[week 4\]) minus log (Baseline value).

Secondary Outcome Measures

Name	Time	Method
Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time	Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)	Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by \[Baseline value\]).
Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up	Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)	Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline \[Week 1, Week 2 and Follow-up\] values) minus log (Baseline value).

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan