Examples of ethnicity and geography issues in global clinical trials ...

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RE-LY: A Non-inferiority Trial Atrial fibrillation ≥1 Risk Factor Absence of contra-indications 951 centers in 44 countries Blinded Event Adjudication R Open Blinded Warfarin adjusted (INR 2.0-3.0) N=6022 Dabigatran Etexilate 110 mg BID N=6015 Dabigatran Etexilate 150 mg BID N=6076 Mean TTR 64% Wallentin L., et al. Lancet 2010; in press. Dabigatran etexilate is in clinical development and not licensed for clinical use in stroke prevention for patients with atrial fibrillation
RE-LY ® – participating countries Connolly SJ., et al. N Engl J Med 2009; 361:1139-1151. Additional recruitment in10 other countries n = 513 Dabigatran etexilate is in clinical development and not licensed for clinical use in stroke prevention for patients with atrial fibrillation
Page 1 and 2: Examples of ethnicity and geography
Page 3 and 4: Trial Design Placebo NSTE Acute Cor
Page 5 and 6: Subgroups GUSTO Moderate/Severe Pri
Page 7 and 8: PLATO study design NSTE-ACS (modera
Page 9 and 10: Cumulative incidence (%) PLATO: pri
Page 11 and 12: Primary endpoint in predefined subg
Page 13 and 14: Primary endpoint in predefined subg
Page 15 and 16: No Systematic Errors • US and ROW
Page 17 and 18: High-dose Aspirin Use: Landmark Tim
Page 19 and 20: Primary Efficacy Outcome US and Non
Page 21: Summary • In PLATO, ticagrelor re
Page 25 and 26: Primary Outcome Sub-groups (3) Dabi
Page 27 and 28: % per year Stroke / SSE According t
Page 30 and 31: Ethnicity and geography issues in g

Examples of ethnicity and geography issues in global clinical trials ...

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