SB-480848 In Subjects With Coronary Heart Disease

Phase 2

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: SB-480848; Drug: placebo

• Registration Number: NCT00269048
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

Detailed Description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeks

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 969

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	SB-480848	SB-480848
Arm 2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
On treatment sustained inhibition of plasma Lp-PLA2 activity.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Difference in dose-dependent effects of SB-480848 on plasma Lp-PLA2 activity, other biomarkers, and safety.	12 Weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Tarrasa, Barcelona, Spain