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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-26

Study Completion Date

2009-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Group

Matched Placebo

Group Type PLACEBO_COMPARATOR

SB480848 Placebo Tablet

Intervention Type DRUG

1 tablet once a day

SB480848 40mg Group

SB480848 40mg/day

Group Type EXPERIMENTAL

SB480848 40mg EC Tablet

Intervention Type DRUG

1 tablet once a day

SB480848 80mg Group

SB480848 80mg/day

Group Type EXPERIMENTAL

SB480848 80mg EC Tablet

Intervention Type DRUG

1 tablet once a day

SB480848 160mg Group

SB480848 160mg/day

Group Type EXPERIMENTAL

SB480848 160mg EC Tablet

Intervention Type DRUG

1 tablet once a day

Interventions

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SB480848 40mg EC Tablet

1 tablet once a day

Intervention Type DRUG

SB480848 80mg EC Tablet

1 tablet once a day

Intervention Type DRUG

SB480848 160mg EC Tablet

1 tablet once a day

Intervention Type DRUG

SB480848 Placebo Tablet

1 tablet once a day

Intervention Type DRUG

Other Intervention Names

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Darapladib

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Study Documents

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