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

Atherosclerosis Clinical Trial

Official title:

A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734032
• Other study ID #: LPL110118
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2008
• Last updated: January 10, 2018
• Start date: August 26, 2008
• Est. completion date: January 16, 2009

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 16, 2009
• Est. primary completion date: January 16, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• SB480848 40mg EC Tablet
1 tablet once a day
• SB480848 80mg EC Tablet
1 tablet once a day
• SB480848 160mg EC Tablet
1 tablet once a day
• SB480848 Placebo Tablet
1 tablet once a day

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity	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).	Baseline (Week 0, Visit 2) and Week 4
Secondary	Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time	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]).	Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
Secondary	Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up	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).	Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)

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