Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
336 participants
INTERVENTIONAL
2005-11-10
2007-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Subjects with ACS and evidence of MN:SB-480848
Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks
SB-480848
SB-480848 is available as enteric-coated, free-base micronized tablet
Subjects with ACS and evidence of MN: placebo
Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks
SB-480848 matching placebo
Placebo is available as enteric-coated, free-base micronized tablet
Non-ACS and ACS subjects without evidence of MN: SB-480848
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
SB-480848
SB-480848 is available as enteric-coated, free-base micronized tablet
Non-ACS and those ACS subjects without evidence of MN: placebo
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
SB-480848 matching placebo
Placebo is available as enteric-coated, free-base micronized tablet
Interventions
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SB-480848
SB-480848 is available as enteric-coated, free-base micronized tablet
SB-480848 matching placebo
Placebo is available as enteric-coated, free-base micronized tablet
Eligibility Criteria
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Inclusion Criteria
* Suitable non-intervened coronary artery with IVUS
* Antiplatelet therapy
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Vienna, , Austria
GSK Investigational Site
Aalst, , Belgium
GSK Investigational Site
Antwerp, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Aarhus N, , Denmark
GSK Investigational Site
Besançon, , France
GSK Investigational Site
Brest, , France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Bad Nauheim, Hesse, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Eindhoven, , Netherlands
GSK Investigational Site
Enschede, , Netherlands
GSK Investigational Site
Leeuwarden, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
Bergen, , Norway
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Marid, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Lucerne, , Switzerland
Countries
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References
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Serruys PW, Garcia-Garcia HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Botker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.
Study Documents
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Document Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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SB-480848/026
Identifier Type: -
Identifier Source: org_study_id
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