<<

Date of end of Target No of No REC Ref Title Recruitment Trial Status Target Met Patients Window at STH

MiroCam endoscopy of the small bowel in patients with GI bleeding/iron deficiency 1 11/YH/0009 Anaemia and findings at upper and lower GI endoscopy of unclear bleeding potential 20 01/01/2017 Open N/A

A randomised, multicentre, open-label Phase III study to evaluate the efficacy and safety of Emtansine versus Trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumour present pathologically in 2 12/LO/1981 the breast or axillary lymph nodes following preoperative therapy. KATHERINE 4 30/04/2016 Open N/A

A randomised, double blind, placebo controlled, parallel group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients 3 12/WS/0300 who have recently experienced an acute coronary syndrome 25 01/12/2015 Open N/A An Open, Phase I, Exploratory Study of MTL-005 Radiosensitization in Patients With Advanced Carcinoma of the Head and Neck: Part 1 to Evaluate Safety in a Dose Escalation Design in Patients Indicated for Palliative Radiotherapy, Part 2 to Evaluate Safety and Efficacy in a Dose-Escalation Design in Patients Indicated for Cisplatin Chemoradiotherapy - 4 12/YH/0498 MOREX 8 31/05/2016 Suspended N/A

5 13/EE/0312 Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3) 10 31/10/2015 Open N/A

A Phase II Randomised, Double Blind, Placebo Controlled, Multicentre Study of VS-6063 in 6 13/EM/0230 Subjects With Malignant Pleural Mesothelioma 5 01/10/2015 Open N/A

A Phase II Simon Two Stage Efficacy Study of Intracerebral CTX0E03 DP in Patients with 7 13/LO/1174 Stable Paresis of the Arm Following an Ischaemic Stroke. 3 31/03/2016 Open N/A

A multicentre, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and 8 13/LO/1328 mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction 6 31/03/2016 Open N/A CALM-NET: A Phase IV, Multicentre, Open label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients receiving Deep Subcutaneous Administrations of Somatuline® (lanreotide) Autogel® to treat the Symptoms 9 13/LO/1557 of Functioning Midgut NeuroEndocrine Tumours (NET). 4 30/11/2015 Open N/A A randomised, double-blind, placebo controlled, multicentre trial to measure the oral corticosteroid-sparing effect of lebrikizumab in patients with severe corticosteroid 10 13/NI/0148 dependent asthma - VOCALS 7 31/05/2016 Open N/A

Prospective, randomised, controlled investigation comparing the safety and performance of 032-11 Surgical Haemostat 2g Applicator with FLOSEAL® Hemostatic Matrix as an 11 13/NW/0002 adjunctive haemostat in cardiac surgery and thoracic aortic surgery. 17 Open N/A

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and , Post-Polycythemia Vera 12 14/EM/0186 Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (PERSIST-2) 3 01/01/2018 Open N/A

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with 13 14/LO/0362 inoperable chronic thromboembolic pulmonary hypertension (CTEPH) 2 01/10/2016 Open N/A A randomised, doubleblind, parallel group, placebo controlled multicentre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant 14 14/LO/0566 3 30/11/2017 Open N/A A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral MLN9708 Maintenance Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell 15 14/LO/0673 Transplant - Millennium 3 01/12/2016 Open N/A

Study 110933: Albiglutide versus Placebo in Subjects with new- onset type 1 diabetes 16 14/LO/1617 mellitus 4 01/11/2015 Open N/A

STOP-HCC TS-103 A phase 3 clinical trial of intra-arterial TheraSphere in the treatment of 17 14/LO/2182 patients with unresectable hepatocellular carcinoma 2 30/01/2018 In set up N/A

Pressure controlled Intermittent Coronary Sinus Occlusion as an adjunct to PCI in acute coronary syndrome. An observational study evaluating the effect of PICSO treatment concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial 18 14/NE/1129 Infarction or following pPCI in ST-segment Elevation Myocardial Infarction. 12 31/03/2016 Open N/A A 4 week phase 2a, multicentre, randomised, doubleblind, placebo-controlled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin 19 14/NW/0119 or gabapentin 10 01/10/2015 Open N/A

A Phase III, multi-center, double-blind, placebo controlled, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s 20 14/NW/1294 disease who are candidates for medical therapy. 2 13/05/2016 Open N/A Comparative testing of Transfix Vacuum blood collection tubes and Cytochex blood collection tubes for FDA 510 (k) submission 21 14/NW/1531 18 30/11/2015 Open N/A A phase 3 randomized, double-blind study assessing the efficacy and safety of pf- 06410293 and adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response 22 14/SC/1203 to methotrexate 1 28/02/2016 Open N/A A Multicenter, Randomized, Double Blind, Placebo controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add on to Insulin Therapy 23 14/SC/1361 in Subjects with Type 1 Diabetes Mellitus 5 31/10/2015 Open N/A

EPOCH: Protocol TS-102: A phase 3 clinical trial evaluating Therasphere in patients with 24 14/SC/1366 metastatic colorectal carcinoma of the liver who have failed first line chemotherapy 3 01/02/2016 In set up N/A A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, split dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 25 14/SS/1048 Due to Autosomal Dominant Polycystic Kidney Disease 5 01/10/2015 Open N/A

A multinational, randomised, double blind, placebo controlled trial to evaluate the effect of ticagrelor 90mg twice daily on the incidence of cardiovascular death, myocardial 26 14/WM/0027 infarction or stroke in patients with type 2 diabetes mellitus. (THEMIS) 20 30/09/2015 Open N/A A phase 3, multicentre, open label, randomised trial of nab-Paclitaxel plus Gemcitabine versus Gemcitabine alone as adjuvant therapy in subjects with surgically resected 27 14/WS/0068 pancreatic adenocarcinoma 10 31/01/2016 Open N/A

A Phase 2, Randomized, Placebo Controlled, Double Blind, Proof of concept Study of the 28 14/YH/1112 Efficacy and Safety of PF02545920 in Subjects with Huntington’s disease 4 01/01/2016 Open N/A A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer with bone metastases treated with hormonal treatment 29 14/YH/1141 background therapy 4 01/06/2016 In set up N/A

Hypertrophic Cardiomyopathy Study - Phase 2 study to evaluate the safety and efficacy of a novel compound, GS-6615 30 15/LO/0040 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy 4 30/06/2016 Open N/A A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary 31 15/LO/0337 hypertension 2 01/06/2016 Open N/A

Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients 32 15/LO/0413 with Geographic Atrophy Secondary to Age-related Macular Degeneration. 8 30/08/2016 Open N/A

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without as First-line Therapy in Patients With Metastatic 33 15/LO/0448 Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL) 5 31/12/2016 Open N/A Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3 period, multicentre study with open-label follow- 34 15/LO/0684 up extension. 5 01/12/2015 Open N/A

“ExplorerTM3” A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab 35 15/LO/1074 administered subcutaneously to haemophilia A subjects. Trial ID: NN7415-4159 1 01/03/2017 Open N/A A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS- 36 15/SS/0050 4997 in Subjects with Pulmonary Arterial Hypertension 2 03/02/2016 Open N/A

ZINN - Randomized, Doubleblind, Multicenter, Phase III Study Comparing the Efficacy and 37 15/YH/0003 Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor 6 01/08/2016 Open N/A An open label extension study to investigate the long term safety, tolerability and efficacy of PF-02545920 in subjects with Huntington's disease who previously completed study 38 15/YH/0127 A8241021 4 01/10/2017 Open N/A

39 15/YH/0188 Acceptability study on Nutricomp® Drink Plus in adult patients 15 31/10/2015 Open N/A

A phase 3, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of multiple Dupilumab dose regimens administered as monotherapy for 40 15/YH/0243 maintaining treatment response in patients with atopic dermatitis. 2 01/12/2015 Open N/A A Phase I study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes virus HSV1716 into the tumour-bearing pleural cavity (intrapleural) in patients with inoperable malignant pleural 41 GTAC177 mesothelioma 12 31/12/2015 Open N/A

ALTTO - A randomised, multicentre, open-label, Phase III study of adjuvant , trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive 42 07/MRE01/68 primary breast cancer 25 14/01/2010 Closed - In Follow Up N Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, 43 07/S0501/66 event driven Phase IV study 3 30/03/2012 Closed – Follow Up Complete N A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC 44 09/H0301/5 FOLLOWING SECOND-LINE THERAPY 6 30/04/2015 Closed – Follow Up Complete N A randomised double blind placebo-controlled trial of (HKI-272) after Trastuzumab in women with early-stage HER-2/neu overexpressed/amplified breast 45 09/H0405/44 cancer 10 10/10/2011 Closed - In Follow Up N

ORCHARRD - versus Salvage Chemoimmunotherapy followed by 46 09/H0406/106 ASCT in relapsed or refractory DLBC 7 30/11/2013 Closed – Follow Up Complete N

An Extension Protocol for Multiple Scerosis Patients Who Participated in Genzyme 47 09/H1211/72 Sponsored Studies of Aletmuzumab 17 01/08/2015 Closed - In Follow Up N MARIANNE - A randomised, 3 arm, multicentre, Phase III study to evaluate the efficacy and the safety of T-DM1 combined with or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2-positive progressive or recurrent locally 48 10/H0406/34 advanced or metastatic breast cancer (MBC) 10 15/02/2012 Closed - In Follow Up N

A European Randomised Phase 3 Study To Assess The Efficacy And Safety Of Tookad® 49 10/H0604/79 Soluble For Low Risk Localised Prostate Cancer Compared To Active Surveillance 20 25/04/2013 Closed – Follow Up Complete N Multi-centre, open-label, extension study to evaluate the long-term efficacy and safety of oral tolvaptan tablet regimens in subjects with Autosomal Dominant Polycystic Kidney 50 10/MRE09/30 Disease (ADPKD) 1 24/11/2013 Closed – Follow Up Complete N A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare Efficacy and Safety of Pomalidomide in subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Red Blood Cell-Transfusion- 51 10/NIR02/45 Dependence 5 30/03/2012 Closed - In Follow Up N A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and 52 11/EE/0229 safety of pasireotide LAR in patients with Cushing’s disease 2 30/06/2014 Closed - In Follow Up N

The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: 53 11/ES/0029 Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) 24 21/06/2013 Closed - In Follow Up N

A 12month, Multi-centre, Randomised, Parallel Group Study to Compare the Efficacy and 54 11/LO/1023 Safety of Ozurdex verses Lucentis in Branch Retinal Vein Occlusion 10 31/10/2013 Closed – Follow Up Complete N THERESA Study - A Phase III randomised, multicentre, two-arm, open-label trial to evaluate the efficacy of T-DM1 compared with treatment of Physician’s Choice in patients with HER2-positive metastatic breast cancer who have received at least two prior 55 11/LO/1750 regimens of HER2-directed therapy 3 04/12/2012 Closed - In Follow Up N Randomized, Multicenter, DoubleBlind, Phase 3 Trial Comparing the Efficacy of in Addition to Paclitaxel and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent NonSmall Cell Lung Cancer 56 11/SC/0169 (NSCLC) 5 30/06/2014 Closed - In Follow Up N

A phase 3, randomised, doubleblind, placebo controlled, multicentre study of the efficacy and safety of four 12 week treatment cycles (48 weeks total) of Epratuzumab in Systemic 57 11/WM/0048 Lupus Erythematosus subjects with moderate to sever disease (Embody 1) 2 31/12/2013 Closed – Follow Up Complete N

SuperNOVA: Stenting of the superficial Fenoral and proximal Popliteal Arteries with the 58 11/YH/0085 Scientific INNOVA Self-Expanding Bare Metal Stent System 20 30/06/2013 Closed - In Follow Up N

Protocol I1F-MC-RHBA A Multicenter, Randomized, Double-Blind, Placebo - Controlled Study Comparing the Efficacy and Safety of LY2439821 to and Placebo in 59 12/EE/0089 Patients with Moderate-to-Severe Plaque Psoriasis 5 04/12/2013 Closed - In Follow Up N

A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among 60 12/EM/0018 stable post-myocardial infarction patients with elevated hsCRP (CANTOS) 8 01/01/2015 Closed - In Follow Up N

Randomized, Double-blind, Placebo-controlled Phase 3 Study of (PCI-32765), a Bruton's Tyrosine Kinase (BTK) Inhibitor, in combination with Bendamustine and Rituximab (BR) in Subjects with Relapsed or Refractory B-Cell Chronic Lymphocytic 61 12/EM/0291 Leukemia/Small Lymphocytic (The 'HELIOS' Trial) 4 01/02/2014 Closed - In Follow Up N An observer-blind study to evaluate immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults =18 years of age with solid tumours receiving 62 12/LO/1909 chemotherapy. 5 30/09/2013 Closed - In Follow Up N A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients 63 12/NW/0521 with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics 5 30/11/2013 Closed – Follow Up Complete N

Randomized phase II study of BEZ235 or in advanced pancreatic 64 12/NW/0555 neuroendocrine tumors 3 14/11/2013 Closed – Follow Up Complete N

An open-label randomised Phase III trial of BMS-936558 versus Docetaxel in previously 65 12/SC/0472 treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC) 10 30/08/2013 Closed - In Follow Up N

66 12/YH/0246 BPH-6: A UroLift® Post Market Multi-Center Randomized Study 5 31/12/2012 Closed – Follow Up Complete N Protocol CNTO136ARA3003: A Multicentre, Randomised, Double-blind, Placebo- controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis 67 12/YH/0446 Despite Anti-TNFa Therapy 1 31/08/2014 Closed - In Follow Up N A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects with Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment 68 13/EE/0023 Group for Bone Mineral Density Assessment 6 15/08/2014 Closed – Follow Up Complete N A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with 69 13/EE/0231 Background Treatment of Pirfenidone 3 13/06/2014 Closed – Follow Up Complete N

A multicenter, prospective, randomized, open label study to assess the effect of serelaxin 70 13/EM/0404 versus standard of care in acute heart failure (AHF) patients - RELAX EU 10 01/04/2015 Withdrawn N

A study evaluating the efficacy and safety of Botox and solifenacin in patients with 71 13/ES/0009 overactive bladder and urinary incontinence. 8 01/05/2014 Closed – Follow Up Complete N

PRESENT - Prevention of recurrence in early-stage, node-positive breast cancer with low 72 13/LO/0021 to intermediate HER2 expression with NeuVax treatment 6 23/02/2015 Closed - In Follow Up N

73 13/LO/0219 GS6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) 4 30/06/2015 Closed - In Follow Up N

Efficacy and safety of FIAsp compared to insulin aspart both in combination with insulin 74 13/LO/0663 detemir in Adults with type 1 Diabetes. 6 16/12/2013 Closed – Follow Up Complete N A randomized, double-blind, parallel-group, placebo and active controlled, multicenter study to evaluate the efficacy, safety and tolerability of combinations of solifenacin succinate 5mg and mirabegron 25 and 50mg compared to slifenacin succinate and 75 13/LO/1336 mirabegron monotherapy in the treatment of overactive bladder. 8 13/03/2015 Closed - In Follow Up N The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon (IN.PACT 76 13/NW/0064 Global) 80 31/03/2014 Withdrawn N

Efficacy and safety of a single TRUS-guided intraprostatic injection of NX-1207 in patients 77 13/NW/0193 with BPH/LUTS not adequately controlled by medical therapy with a-blockers. 5 26/11/2014 Closed – Follow Up Complete N

A two part study to assess the safety, tolerability, pharmacokinetics and 78 13/NW/0674 pharmacodynamic effects of multiple doses of QBM076 in patients with COPD 9 01/10/2015 Withdrawn N A double-blind, randomised, placebo-controlled, phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or 79 13/NW/0778 ASCUS/LSIL 2 30/11/2014 Closed – Follow Up Complete N

Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients 80 13/SC/0325 with severe haemophilia A 2 31/12/2014 Closed – Follow Up Complete N

EDIFY - Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, 81 13/YH/0140 international, multicentre study 5 30/06/2015 Closed – Follow Up Complete N

A 6-month, prospective, randomized, multicenter, placebo controlled safety study of oto- 104 given at 3-month intervals by intratympanic injection in subjects with unilateral 82 14/EE/1001 Meniere’s Disease followed by a 6-month open-label extension 10 01/10/2015 Closed - In Follow Up N

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate 83 14/EM/0023 Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis 4 01/07/2016 Withdrawn N An exploratory, 12 week, randomised, partially double-blinded, placebo-controlled, parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by the Respimat® inhaler), supervised exercise training and behaviour modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease 84 14/EM/0101 (COPD) [PHYSACTOTM] 3 29/01/2015 Closed – Follow Up Complete N

Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients 85 14/EM/1042 characterized by eosinophil level 6 25/07/2015 Withdrawn N A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects 86 14/LO/0124 with Overactive Bladder 5 31/08/2016 Closed - In Follow Up N

A Multicenter Phase 3 Randomized, Open-Label Study of versus in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia 87 14/LO/1192 BFORE 3 31/08/2015 Closed - In Follow Up N GS-US-236-0140: A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF) or Efavirenz/Emtricitabine/Tenofovir DF compared to Ritonavir-boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR 88 14/LO/1513 =70 mL/min 1 30/12/2015 Closed – Follow Up Complete N

RELIEVE 1 - A randomised, double-blind, placebo-controlled study to evaluate the efficacy of two different dose levels of Orvepitant (10 and 30 mg) compared with placebo on 89 14/NE/1079 EGFRi-induced intense pruritus in oncology subjects 4 30/06/2015 Closed - In Follow Up N

A 16 Week Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200 and 400 µg of Fluticasone Propionate Twice a Day (BID) Using a Novel BiDirectional Device in Subjects with Bilateral Nasal Polyposis Followed by an 8 Week Open Label Extension - 90 14/NW/1328 NAVIGATE I - Phase to Assess Safety 5 01/04/2015 Closed – Follow Up Complete N Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin 91 14/SC/0100 for Vitreomacular Traction/Symptomatic 6 31/03/2015 Closed – Follow Up Complete N An Individualized treatMent aPproach for EldeRly patients: A randomized, controlled 92 14/YH/0005 stUdy in type 2 diabetes Mellitus (IMPERIUM) 5 05/11/2014 Closed – Follow Up Complete N A Phase 2b, Randomised, Double-Blind, Placebo Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac disease Patients 93 14/YH/0052 Maintained on a Gluten Free Diet. 5 30/09/2014 Closed - In Follow Up N A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA or EPZICOM/KIVEXA, in Treatment-Naïve HIV-1 Infected 94 15/LO/0075 Subjects 1 30/09/2015 Closed - In Follow Up N An Open label, single arm, extension study to evaluate the long term safety and sustained efficacy of Denosomab (AMG162) in the treatment of postmenopausal osteoporosis. 95 07/H0405/70 Protocol 20060289 9 01/04/2010 Closed – Follow Up Complete N Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in 96 06/MRE04/84 patients with multiple sclerosis with relapses 1 30/10/2012 Closed – Follow Up Complete Y A randomised, double-blind, placebo-controlled, multicentre, Phase II study of oral lapatinib in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in subjects with Stage III and IVA,B Squamous Cell Carcinoma of the 97 06/MRE12/35 Head and Neck (SCCHN) 6 06/01/2009 Closed - In Follow Up Y

Freedom 304: TDE-PH-304: “An Open-Label Extension Trial of UT-15C SR in Subjects with 98 07/S0703/2 Pulmonary Arterial Hypertension 5 30/04/2011 Closed - In Follow Up Y A phase III, randomised, open-label, 3-arm study to determine the efficacy & safety of Lenalidomide (Revlimid) plus low dose Dexamethasone when given until progressive disease or for 18 four-week cycles versus the combination of Melphalan, Prednisolone & Thalidomide given for 12 six-week cycles in patients with previously untreated Multiple Myeloma who are either 65 years of age or older or not candidates for stem cell 99 08/H0605/65 transplantation. 5 31/12/2010 Closed - In Follow Up Y

A Multinational, multicentre, open label single assignment extension of the MS-LAQ-301 (ALLEGRO) study to evaluate the long term safety tolerability and effect on disease course 100 09/H0402/96 of daily oral laquinamod 0.6mg in subjects with relapsing multiple sclerosis 5 30/11/2010 Closed - In Follow Up Y A Dose Blind Multicenter Extension study to Determine the Long Term safety and Efficacy of Two doss of BG00012 Monotherapy in Subjects with Relapsing Remitting Multiple 101 09/H0505/94 Sclerosis 2 31/10/2010 Closed - In Follow Up Y

Phase I/II/II Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, 102 09/MRE09/02 IB1001, in Subjects with Hemophilia B 3 30/04/2011 Closed - In Follow Up Y A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple 103 10/H0903/7 Scleosis Who Have Completed Treatment in Study 205MS202 (SELECTION) 205-MS-205 4 03/11/2011 Closed - In Follow Up Y A single arm, open-label, multicentre study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with 104 10/H0904/49 relapsing forms of multiple sclerosis (CFTY720D2399) 11 01/08/2011 Closed - In Follow Up Y A randomised, double-blind, placebo-controlled, multi-centre Phase 3 study of as adjuvant treatment for women with early-stage breast cancer at high risk 105 10/H1002/27 of Recurrence (D-CARE) 20 30/07/2012 Closed - In Follow Up Y A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design (GALA Study), protocol numbers MS-GA- 106 10/H1003/37 301 4 31/01/2011 Closed - In Follow Up Y A Randomised, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a back ground of Salcyclic Acid (ASA) Therapy in Patients with History of Myocardial 107 10/H1010/63 Infarction (PEGASUS) 40 01/01/2014 Closed – Follow Up Complete Y A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects 108 10/H1307/91 with Hypereosinophilic Syndrome 1 01/01/2016 Open Y E7080- A multicentre, randomised double-blind placebo-controlled phase 3 trial of E7080 109 11/ AL/0334 in I-refractory differentiated thyroid cancer 2 01/12/2012 Closed - In Follow Up Y Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL) A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment with 110 11/AL/0042 Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus. 15 01/05/2015 Closed - In Follow Up Y

111 11/EE/0135 BOTOX Prophylaxis in Chronic Migraine: Postauthorization Observational Study 8 28/02/2014 Closed – Follow Up Complete Y A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Patients with Secondary Progressive 112 11/LO/0537 Multiple Sclerosis 12 13/02/2013 Closed - In Follow Up Y Randomised open-label study of Abiraterone Acetate (JNJ-212082) plus Prednisone with or without Exemestane in postmenopausal women with ER+ metastatic breast cancer 113 11/LO/0854 progressing after Letrozole or Anastrozole therapy 5 11/04/2013 Closed – Follow Up Complete Y LUXHead & Neck 2; A randomised, doubleblind, placebo controlled, phase III study to evaluate the efficacy and safety of (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb 114 11/LO/0954 locoregionally advanced head and neck squamous cell carcinoma. 5 28/03/2015 Suspended Y PERTAIN Study - A randomised, two-arm, open-label, multicentre Phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line patients with HER2-positive and hormone receptor- 115 11/LO/1921 positive advanced (metastatic or locally advanced) breast cancer 3 03/11/2014 Closed - In Follow Up Y

Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an 116 11/NE/0226 open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects 13 28/02/2013 Closed – Follow Up Complete Y APHINITY BIG 4-11/BO25126: A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2- 117 11/SS/0018 positive primary breast cancer 5 16/07/2013 Closed - In Follow Up Y Prospective observational long-term safety registry of Multiple Sclerosis patients who 118 11/YH/0142 have participated in cladribine clinical trials 3 30/09/2018 Open Y The BEACON Study (Breast Cancer Outcomes with NKTR-102: A Phase 3 open-label, randomised multicentre study of MKTR-102 versus treatment of Physician’s Choice (TPC) in patients with locally recurrent or metastatic breast cancer previously treated with an 119 12/EE/0178 anthracycline, a taxane and capecitabine 5 24/07/2013 Closed - In Follow Up Y

120 12/LO/0025 NN7088-3859 Trial Evaluating Safety and Efficacy of N8GP in Haem A (Pathfinder 2) 2 01/02/2013 Closed - In Follow Up Y

NN70883860 Efficacy and Safety of N8GP during Surgery in Haem A - CCRN 757 121 12/LO/0026 (Haemophilia A) Pathfinder 3 1 30/04/2013 Closed – Follow Up Complete Y MO28231 TDM1 Safety Study - A multicentre, single arm study of Trastuzumab Emtasine (TDM1) in HER2 positive locally advanced or metastatic breast cancer patients who have 122 12/LO/1351 received prior anti HER2 and chemotherapy based treatment. 8 31/10/2013 Closed - In Follow Up Y A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT- 1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple 123 12/LO/1679 sclerosis 5 24/12/2013 Closed – Follow Up Complete Y

International non-randomized, single arm, long-term follow-up study of patients with 124 12/LO/1731 uncontrolled hypertension 10 31/01/2015 Open Y Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive 125 12/LO/1889 multiple sclerosis (STH15105 Extension) 8 01/09/2014 Closed - In Follow Up Y A multinational, multicenter, randomized, double-blind, parallel-group, placebo- controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of daily oral administration of laquinimod 0.6 mg and 1.2 mg in subjects 126 12/NW/0802 with relapsing remitting multiple sclerosis (RRMS). CONCERTO 5 01/02/2015 Closed - In Follow Up Y

Phase II/III partial randomized, open label trial using BAY 94-9027 for the prophylaxis and 127 12/SC/0293 treatment of bleeding in severe Haemophilia A (PROTECT VIII) 3 01/10/2013 Closed – Follow Up Complete Y

A double-blind, randomised, placebo-controlled, multicentre study assessing the impact on major cardiovascular events of additional LDL-C lowering with AMG145 therapy when 128 12/WM/0341 used on top of a high dose statin in patients with coronary artery disease. FOURIER 10 01/04/2015 Closed - In Follow Up Y A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Beta-1a (BIIB017) in Subjects With Relapsing 129 12/WS/0145 Multiple Sclerosis 3 26/06/2013 Closed - In Follow Up Y A prospective randomized comparison of the BioFreedom™ Biolimus A9™ Drug Coated Stent versus the Gazelle™ Bare Metal Stent in Patients at High Risk for Bleeding (Leaders 130 12/WS/0305 free) 15 30/03/2014 Closed - In Follow Up Y A study of the effect of OC000459 on signs & symptoms in subjects with moderate to severe atopic dermatitis: a randomised double blind placebo controlled parallel group 131 13/EM/0248 study. 5 31/05/2015 Open Y A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s 132 13/EM/0424 Disease Phase 2 2 01/07/2015 Open Y

KAITLIN – A randomised, multicentre, open-label, Phase III trial comparing Trastumzumab plus Pertuzumab plus a taxane following anthracyclines versus plus Pertuzumab following anthracyclines as adjuvant therapy in patients with operable 133 13/EM/0460 HER2-positive primary breast cancer 7 31/12/2015 Closed - In Follow Up Y

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects with 134 13/LO/0072 Chronic Kidney Disease on Haemodialysis (20120229) 3 07/10/2013 Closed – Follow Up Complete Y A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic 135 13/LO/0073 Kidney Disease on Hemodialysis 2 29/05/2014 Closed – Follow Up Complete Y A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT- 1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple 136 13/LO/0195 sclerosis EXTENSION 5 31/05/2014 Closed - In Follow Up Y A Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With 137 13/LO/0671 Multiple Sclerosis Who Have Completed Study 205MS301 15 28/02/2014 Closed - In Follow Up Y

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus 138 13/LO/1302 tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women 2 29/09/2014 Closed - In Follow Up Y A single-arm, open-label, multicentre, non-randomised, study to assess the effect and tolerability of standardised laxative therapy (SLT) for the reversal of opioid-induced constipation (OIC) in subjects suffering from malignant or non-malignant pain that 139 13/NE/0248 requires around-the-clock opioid therapy 1 26/05/2014 Closed – Follow Up Complete Y

PEARL - A double blind, randomised, placebo controlled Phase II study to assess the efficacy of recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant 140 13/NW/0215 therapy in patients with resected PRAME-positive, non-small cell lung cancer 5 11/07/2014 Closed – Follow Up Complete Y An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and 141 13/NW/0278 cannot participate in any other CTEPH trial 3 01/02/2014 Closed - In Follow Up Y Randomised, double-blind, dose-finding Phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplatin- or 142 13/NW/0462 anthracycline/cyclophosphamide (AC)-based chemotherapy 7 30/01/2015 Closed – Follow Up Complete Y A Phase 2/3, multi-centre, open-label, randomised study of weekly nab®-Paclitaxel in combination with Gemcitabine or Carboplatin, compared to Gemcitabine/Carboplatin, as first line treatment in subjects with ER, PgR, and HER2 negative (triple negative) 143 13/NW/0637 metastatic breast cancer - TNACITY 7 01/02/2018 Closed - In Follow Up Y A multicenter, randomized, double blind parallel group placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in 144 13/SC/0092 patients with secondary progressive multiple sclerosis 5 31/01/2015 Closed - In Follow Up Y A Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with in patients with unresectable or 145 13/SC/0478 metastatic BRAF V600 mutant melanoma 3 31/05/2015 Open Y A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable 146 13/WA/0178 Pancreatic Adenocarcinoma (MAESTRO) 2 30/06/2014 Closed - In Follow Up Y A phase III, randomized, double-blind, placebo controlled study to assess the efficacy and safety of lebrikizumab in patients with uncontrolled asthma who are on inhaled 147 13/YH/0320 corticosteroids and a second controller . Lavolta I/II 1 10/12/2014 Closed - In Follow Up Y Multicentre, Randomised, DoubleBlind, Placebo Controlled, Phase 3 Trial of Fulvestrant (Faslodex®) With or Without PD0332991 () ± Goserelin in Women with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Whose Disease 148 14/EE/0035 Progressed After Prior Endocrine Therapy. PALOMA 1 15/07/2014 Closed - In Follow Up Y TOPAZ: A long-term follow-up study for Multiple Sclerosis patients who have completed 149 14/EE/1113 the Extension Study (CAMMS03409 STH15866) 15 01/07/2016 Open Y A Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled (Part A) And Double-Blind, Double-Dummy, Active-Controlled (Part B), Parallel Group Study To Evaluate The Efficacy And Safety Of Rpc1063 Administered Orally To Relapsing Multiple 150 14/EM/0129 Sclerosis Patients 3 17/02/2015 Closed - In Follow Up Y

A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the 151 14/EM/1102 FOURIER (Study 20110118) Trial Evolocumab (AMG 145) 1 31/03/2015 Closed - In Follow Up Y

A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Versus Standard of Care Chemotherapy in Adult Subjects With 152 14/LO/0036 Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) 1 01/03/2016 Open Y A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in 153 14/LO/0590 Pregnant Women 0 30/09/2015 Closed – Follow Up Complete Y

154 14/YH/0167 Tolerance and Acceptabiltiy Evaluation of AYMES DELIGHT 0 16/12/2014 Closed – Follow Up Complete Y The “QUIET-1” Study: A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective 155 14/YH/1090 Tinnitus 10 31/12/2015 Open Y A Phase 3 Confirmatory Study Investigating The Efficacy And Safety Of Dupilumab Monotherapy Administered To Adult Patients With Moderate -To severe Atopic 156 15/YH/0005 Dermatitis 5 31/07/2015 Closed - In Follow Up Y