PERFORMANCE IN DELIVERING CLINICAL RESEARCH Q1 (2015-2016) Research Date Target Ethics Agreed to Met Target Trial Committee Name of Trial Recruit Within Recruitment Status Reference Target Agreed Number Number Time A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or 13/EE/0339 50 30/09/2015 OPEN N/A peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS) 047 FIT - C-935788-047 A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 14/EM/1059 Study of Fostamatinib Disodium in 3 01/09/2015 OPEN N/A the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura RESPONSE: A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and CLOSED AT 14/NW/0130 7 31/03/2015 NO tolerability of NT100 in pregnant SITE women with a history of unexplained recurrent pregnancy loss (RPL) Assessment of an Education and Guidance programme for Eliquis CLOSED - 13/NW/0858 12 31/03/2015 NO Adherence in Non-Valvular Atrial In Follow-up Fibrillation (AEGEAN) ENSURE in AF (atrial fibrillation) study. A prospective, randomized, openlabel, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban 14/EE/0102 9 01/12/2015 OPEN YES (DU176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732, & LTS11717 Studies to Assess the Long-Term 14/WS/0004 4 31/12/2014 CLOSED YES Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia ODYSSEY OLE Post-Market Multicentric Evaluation of the AQUESYS XEN CLOSED - 14/EE/0059 Implant in Moderate Primary Open 10 02/02/2015 NO In Follow-up Angle Glaucoma Subjects. Study
PERFORMANCE IN DELIVERING CLINICAL RESEARCH Q1 (2015-2016) Research Ethics Committee Reference Number Name of Trial Target Recruitment Date Agreed to Recruit Target Number Trial Status Target Met Within Agreed Time 13/EE/0339 A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS) 50 30/09/2015 OPEN N/A 14/EM/1059 047 FIT - C-935788-047 A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura 3 01/09/2015 OPEN N/A 14/NW/0130 RESPONSE: A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL) 7 31/03/2015 CLOSED AT SITE NO 13/NW/0858 Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) 12 31/03/2015 CLOSED - In Follow-up NO 14/EE/0102 ENSURE in AF (atrial fibrillation) study. A prospective, randomized, openlabel, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation 9 01/12/2015 OPEN YES 14/WS/0004 Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732, & LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia ODYSSEY OLE 4 31/12/2014 CLOSED YES 14/EE/0059 Post-Market Multicentric Evaluation of the AQUESYS XEN Implant in Moderate Primary Open Angle Glaucoma Subjects. Study 10 02/02/2015 CLOSED - In Follow-up NO
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