Integrated Biomarker And Imaging Study - 2

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis

Treatments: Drug: SB-480848; Drug: SB-480848 matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00268996

SB-480848/026

Details and patient eligibility

About

IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

Full description

Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.

Enrollment: 336 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
• Suitable non-intervened coronary artery with IVUS
• Antiplatelet therapy

Exclusion criteria

• Clinical instability
• Previous CABG (Coronary Artery By-pass Graft) surgery
• Planned major surgery
• Recent stroke
• Abnormal QTc
• Renal or hepatic impairment
• Uncontrolled hypertension
• Use of corticosteroids
• Class III or IV heart failure
• Asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 4 patient groups, including a placebo group

Subjects with ACS and evidence of MN:SB-480848

Experimental group

Description:

Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks

Treatment:

Drug: SB-480848

Subjects with ACS and evidence of MN: placebo

Placebo Comparator group

Description:

Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks

Treatment:

Drug: SB-480848 matching placebo

Non-ACS and ACS subjects without evidence of MN: SB-480848

Experimental group

Description:

Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks

Treatment:

Drug: SB-480848

Non-ACS and those ACS subjects without evidence of MN: placebo

Placebo Comparator group

Description:

Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks

Treatment:

Drug: SB-480848 matching placebo