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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00734032

First received: August 12, 2008

Last updated: June 21, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2008

Last Updated Date

June 21, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline to week 4 in plasma Lp-PLA2 activity [ Time Frame: 4 weeks ]

Original Primary Outcome Measures ^ICMJE

Change from baseline to week 4 in plasma Lp-PLA2 activity

Change History

Complete list of historical versions of study NCT00734032 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

•Percent inhibition of Lp-PLA2 activity in plasma at week 4•Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline [ Time Frame: 4 weeks ]

Original Secondary Outcome Measures ^ICMJE

•Percent inhibition of Lp-PLA2 activity in plasma at week 4 •Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 -

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dyslipidaemia
Atherosclerosis

Intervention ^ICMJE

Drug: SB480848 40mg EC Tablet
1 tablet once a day

Other Name: Darapladib
Drug: SB480848 80mg EC Tablet
1 tablet once a day
Drug: SB480848 160mg EC Tablet
1 tablet once a day
Drug: SB480848 Placebo Tablet
1 tablet once a day

Study Arm (s)

Placebo Comparator: Placebo Group
Matched Placebo

Intervention: Drug: SB480848 Placebo Tablet
Experimental: SB480848 40mg Group
SB480848 40mg/day

Intervention: Drug: SB480848 40mg EC Tablet
Experimental: SB480848 80mg Group
SB480848 80mg/day

Intervention: Drug: SB480848 80mg EC Tablet
Experimental: SB480848 160mg Group
SB480848 160mg/day

Intervention: Drug: SB480848 160mg EC Tablet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

107

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.,<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
Planned CABG or planned PCI or planned major non-cardiac surgery within study period
No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00734032

Other Study ID Numbers ^ICMJE

LPL110118

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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