Ongoing clinical trials 01.08.2010Number Reference No. Sponsor Protocol No. Full title of the trial Submission date 1 02-010 Wyeth Ayerst Research 3068A1-301-EU Fracture Incidence reduction and safety of TSE-424 (Basedofixene acetate) compared to placebo and raloxifene in osteoporotic postmenopausal women 28.01.2002 2 02-019 GlaxoSmithKline Biologicals SA 249553/004 A double-blind, randomised, placeebo-controlled Phase IIB study to assess the efficacy of GSK 249553 as adjuvant theraphy given to MAGE-3 positive patients with non-small-cells lung cancer (NSCLC) in stage IB (T2/NO) orII (T1/N1 or T2/N0 or T3/N0), who have had complete surgical resection) 28.03.2002 3 02-051 FibroGen Europe OY FGCS-GEL-272-001 Rekobinantse sünteetiliseŽþelatiin-abiaine ohutuse uuring tervetel inimestel 14.10.2002 4 03-049 Aventis Pharma Deutschland HOE 901/4032 A multicenter, international, randomised, 2x2 factorial design study to evaluate the effects of Lantus® (insulin glargine) versus standard care, and of omega - 3 fatty acids versus placebo, in reducing cardiovascular morbidity and mortality in high risk people with impaired fating glycose (IFG), impaired glucose tolerance (IGT) or early type 2 diabetes mellitus 19.11.2003 5 03-056 Pfizer H.C.P. Corporation CDP870-034 A phase 3, multi-national, multi-centre, open label, 52 week safety study to assess the safety of re-exposure after a variable interval and subsequent chronic therapy with the humanised anti-TNF PEG conjugate CDP870, 400 mg sc, (dosed at weeks 0, 2 and 4 then 4-weekly to week 48) in the treatment of patients with active Crohn"s Disease who have previously been withdrawn from studies CDP870-031 or CDP870-032 due to an exacerbation of Crohn"s Disease 27.11.2003 6 03-057 UCB Celltech CDP870-033 A phase 3, multi-national, multi-centre, open label, 52 week safety study to assess the safety of chronic therapy with the humanised anti-TNF PEG conjugate CDP870, 400 mg sc, (dosed 4-weekly to week 48) in the treatment of patients with active Crohn"s Disease who have previously completed studies CDP870-031 or CDP870-032 27.11.2003 7 03-070 Yamanouchi Europe B.V. 617-CL-310 A randomised, double-blind, parallel group, multicenter study to explore the pharmacokinetics, safety, tolerability and efficacy in paediatric patients with signs and symptoms of dysfunctional voiding 23.12.2003 8 04-002 Janssen Pharmaceutica N.V EVITA Evra - Innovative Contraception by Transdermal Application 12.01.2004 9 05-027 UCB Celltech CDP870-028 A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis 12.07.2005 10 05-051 Pierre Fabre Medicament V00034CR3071B Long-term management of atopic dermatitis with the emollient V0034CR. A randomised, placebo-controlled, parallel-groups, double-blind study in infants and children 19.09.2005 11 05-063 Nordic Bioscience SMC021A-2303 A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal woman taking calcium and vitamin D 10.11.2005 12 05-073 UCB Celltech CDP870-051 A phase III multi-center, open-label, follow-up study, to assess the safety and efficacy of liquid certolizumab pegol as additional medication to methotrexate, in the treatment of signs and symptoms and in the prevention of joint damage in patients with active rheumatoid arthritis who participated in study CDP870-050 13.12.2005 13 06-007 BAYER Healthcare AG BAY 59-7939/11357 RECORD 2 Study: REgulation of Coagulation in ORthopedic surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement 10.02.2006 14 06-015 F. Hoffmann-La Roche Ltd. MO19631 Randomized, two arm, controlled study to compare the efficacy of oral ibandronate treatment versus intravenous zoledronate in patients with symptomatic Multiple Myeloma
21.03.2006 15 06-028 Amgen Inc. 20050222 A double-blind, randomized, placebo-controlled, multicenter study to assess the efficacy and safety of Darbepoetin alfa treatment on mortality and morbidity in Heart Failure (HF) subjects with symptomatic left ventricular systolic dysfunction and anemia. 15.05.2006 16 06-033 Amgen Inc. 20050103 A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer. 31.05.2006 17 06-034 Amgen Inc. 20050136 A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer. 31.05.2006 18 06-044 Takeda Global Research & Development center, Inc. SYR-322-OLE-012 A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects with Type 2 Diabetes 30.06.2006 19 06-048 F. Hoffmann La Roche AG MO19391 Open-label study of bevacizumab (Avastin®) plus taxane monotherapy or in combination for the first-line treatment of patients with locally recurrent or metastatic breast cancer 25.07.2006 20 06-049 sanofi-aventis recherche & développement EFC6034 An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis 26.07.2006 21 06-059 Genmab A/S Hx-EGFr-202 An Open-labeled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy. 5.09.2006 22 06-070 Merck Serono S.A. 27025 A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis 31.10.2006 23 06-073 GlaxoSmithKline Research & Development VEG105281 A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease 7.11.2006 24 06-076 GlaxoSmithKline Research & Development EGF102988 A-Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) 26.10.2006 25 06-087 Institut de Recherches Internationales Servier (IRIS) CL3-12911-018 The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 2 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study. 15.12.2006 26 06-088 Astellas Pharma Europe 150-CL-008 Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.
A double blind, parallel, dose-finding study in comparison with open label enoxaparin
(Study no. 150-CL-008)
Protocol for Phase 2B Study of YM15020.12.2006 27 07-001 ZLB Behring GmbH CE1226_4001 A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to compare the Efficacy and Safety of 60 mg/kg body weight of Zemaira® weekly i.v. administration with Placebo weekly i.v. administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency 8.01.2007 28 07-012 SA TÜK Psühhiaatriakliinik 11739A Effect of sertindole treatment on the cognitive function in patients with chronic schizophrenia 21.02.2007 29 07-022 Nordic Bioscience CSMC021C-2301 A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects with Knee Osteoarthritis. 11.04.2007 30 07-023 GlaxoSmithKline Research and Development Ltd EGF106708 ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study. A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. 8.06.2007 31 07-025 Sanofi-Aventis U.S.Inc. EFC6049 (HMR1726D/3001) A randomized, double-blind, placebo-controlled, parallel group design study to
evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the
frequency of relapses and delaying the accumulation of physical disability in
subjects with multiple sclerosis with relapses.18.04.2007 32 07-026 Ullevål University Hospital 001 Scandinavian Candesartan Acute Stroke Trial 18.04.2007 33 07-028 Eisai Limited E2007-A001-207 An Open-label Extension Phase of the Double-blind, Placebo-controlled,
Dose-escalation, Parallel-group Study of E2007 (perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures (revised per Amendments 02, 03, 05, A and 06)2.05.2007 34 07-031 Janssen-Cilag International NV R076477-PSZ-3002 A 2 year, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5-12 mg/day) in the Treatment of Adolescents (12 to 17 Years of Age) with Schizophrenia 21.06.2007 35 07-032 Biogen Idec Ltd. 109MS302 A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
12.06.2007 36 07-035 Merck & Co.,Inc 0518-023 Early Access of MK-0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options. 29.06.2007 37 07-038 Amgen Inc. 20060289 An Open, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis 11.07.2007 38 07-042 F. Hoffmann La Roche AG MA21056 A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. 11.07.2007 39 07-044 GlaxoSmithKline Biologicals s.a. 110620 A phase II, observer-blind, multicountry, multicentre, randomized study to demonstrate the non-Inferiority of GlaxoSmithKline Biologicals’ one-container AS25 adjuvanted influenza vaccine compared to GlaxoSmithKline Biologicals’ two-container AS25 adjuvanted influenza vaccine in adults aged 65 years and above. 19.07.2007 40 07-046 Ono Pharmaceutical Co., Ltd. ONO-5334POE003 A multi-centre randomised double-blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis 1.08.2007 41 07-049 sanofi-aventis recherche & développement EFC6546 A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated with Docetaxel / Prednisone for Metastatic Androgen-Independent Prostate Cancer 15.08.2007 42 07-052 sanofi-aventis recherche & développement EFC10261 A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 22.08.2007 43 07-057 sanofi-aventis recherche & développement EFC10262 A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients with Metastatic Colorectal Cancer (MCRC) Treated with Irinotecan / 5-FU Combination (FOLFIRI) after failure of an oxaliplatin based regimen. 26.09.2007 44 07-060 CECOG (Central European Cooperative Oncology Group) CECOG/CORE. 1.2.002 A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with metastatic colorectal cancer 1.10.2007 45 07-061 Teva Pharmaceutical Industries Ltd MS-LAQ-301 Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) 10.10.2007 46 07-063 Janssen-Cilag International NV GAL-ALZ-3005 A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease 15.10.2007 47 07-067 F. Hoffmann-La Roche Ltd. NV20234 A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose oseltamivir in the treatment of immunocompromised patients with influenza 24.10.2007 48 07-071 Merck Serono S.A. 27919 A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. 20.12.2007 49 07-073 sanofi-aventis recherche & développement EFC6260 An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period 18.01.2008 50 07-079 GlaxoSmithKline BiologGlaxoSmithKline Biologicals SA 109493 A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung Cancer
4.12.2007 51 07-083 GlaxoSmithKline R&D Ltd ARI109924 A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS – AVODART after Radical Therapy for prostate cancer Study) 11.12.2007 52 07-085 UCB Celltech C87088 A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab" fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 19.12.2007 53 07-087 Cambridge University Hospitals hypertension2006-006981-4 Does the underlying haemodynamic abnormality determine response to antihypertensive therapy in patients with hypertension? 27.06.2008 54 07-088 Merck Serono S.A. 27820 A Phase IIIb, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Whi Have Completed Trial 25643 (CLARITY). 21.12.2007 55 08-005 Teva Pharmaceutical Industries Ltd., Biological & QC Laboratory MS-LAQ-302 A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ?-1a (Avonex®) in a rater-blinded design 6.02.2008 56 08-007 sanofi-aventis recherche & développement EFC6145 A randomized double-blind placebo-controlled parallel group study of the efficacy and safety of 4 administrations of XRP0038/NV1FGF 4mg at 2-week intervals on amputation or any death in critical limb ischemia patients with skin lesions 18.02.2008 57 08-014 MacroGenics, Inc. CP-MGA031-01 A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus 26.02.2008 58 08-017 GlaxoSmithKline R&D EGF110656 A Phase III Study of ErbB2 Positive Advanced or Metastatic Gastric or Esophageal Or Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine Plus Oxaliplatin with or without Lapatinib 4.03.2008 59 08-021 sanofi-aventis recherche & développement EFC10531 A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis 7.04.2008 60 08-027 Dr. Falk Pharma GmbH SAG-37/DIV Double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis. 8.05.2008 61 08-029 sanofi-aventis recherche & développement EFC6521 A multinational, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy. 13.05.2008 62 08-030 Takeda Europe R&D Centre TAK-442_202 A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes 15.05.2008 63 08-032 F. Hoffmann-La Roche Ltd BO20906 A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab 11.06.2008 64 08-035 sanofi-aventis recherche & développement EFC6520 A Multinational, Multicenter, Randomized, Double Blind Study comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery. 12.06.2008 65 08-036 Merck & Co. Inc. 0822-018 A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of MK-0822 to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium 11.06.2008 66 08-039 GlaxoSmithKline research & Development Limited AVD111179 A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study with a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA™ on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus 19.06.2008 67 08-042 BAYER Healthcare AG BAY 59-7939/12839 MAGELLaN - Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin 1.07.2008 68 08-043 GlaxoSmithKline Biologicals s.a. 106372 A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscularly in elderly aged 65 years or above, as compared to Fluarix™. 3.07.2008 69 08-051 F. Hoffmann-La Roche Ltd MO21609 Open-label, single-arm, phase II study of bevacizumab (AVASTIN®)
in combination with low-dose interferon as first-line treatment of
nephrectomised patients with metastatic clear cell renal cell carcinoma10.09.2008 70 08-052 Eisai Limited E2090-E044-313 An open-label extension study following a double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures. 17.09.2008 71 08-053 Vifor (International) Inc FER-IBD-07-MAIN A multi-centre, randomised, prospective, single-blinded, controlled study to investigate the efficacy and safety of a standardised maintenance dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus placebo in patients with iron deficiency caused by inflammatory bowel disease 19.09.2008 72 08-054 VIFOR Inc. FER-IBD-07-COR A multi-centre, randomised, prospective, open-label study to investigate the efficacy and safety of a standardised correction dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus iron sucrose (VENOFER®) for treatment of iron deficiency anaemia in patients with inflammatory bowel disease 19.09.2008 73 08-055 Eisai Limited E2007-G000-307 An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (perampanel) Given as Adjunctive Therapy in Subjects with Refractory Partial Seizures 19.09.2008 74 08-056 H. Lundbeck A/S 12013A A 52-week, randomised, double-blind, placebo-controlled, parallel-group, safety and tolerability study of nalmefene, as needed use, in patients with alcohol dependence 1.10.2008 75 08-057 F. Hoffmann-La Roche Ltd MA21488 Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. 3.10.2008 76 08-060 Boehringer Ingelheim RCV 1160.63 Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism 15.10.2008 77 08-063 Millennium Pharmaceuticals, Inc. C13006 A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis
21.10.2008 78 08-064 Millennium Pharmaceuticals, Inc. C13007 A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the
Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease21.10.2008 79 08-066 Antisoma Research Ltd. 0001A3-300-GL Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML) 27.10.2008 80 08-067 Novartis Pharma Services CLAF237B2224 A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients with type 2 diabetes 31.10.2008 81 08-068 sanofi-aventis recherche & développement EFC10743 A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 24-week study followed by an extension assessing the efficacy and safety of AVE0010 in two titration regimens on top of metformin in patients with type 2 diabetes not adequately controlled with metformin 7.11.2008 82 08-070 Merck Serono S.A. 28821 A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event a high risk of converting to MS 14.11.2008 83 08-071 GlaxoSmithKline research & Development Limited LPL100601 A clinical Outcomes Study of Darapladib versus Placebo in subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Avdverce Cardiovascular Events (MACE). 17.11.2008 84 08-073 Daiichi Sankyo Pharma Limited DU176b-C-U301 A phase 3, randomized, double-blind, double-dummy, parallel group, multicenter, multinational study for evaluation of efficacy and safety of DU-176B versus warfarin in subjects with atrial fibrillation – Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE-AF) 19.11.2008 85 08-074 GlaxoSmithKline Biologicals SA 111482 A double-blind placebo-controlled Phase III study to assess the efficacy of MAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma 21.11.2008 86 08-075 Otsuka Pharmaceutical Development and Commercialization, Inc. 31-07-247 A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia
“ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)21.11.2008 87 08-076 Ida-Tallinna Keskhaigla 35195 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120mg, Etoricoxib 120mg and Paracetamol 1g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery. 3.12.2008 88 08-079 Otsuka Pharmaceutical Development and Commercialization, Inc. 31-08-248 A52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patiens with Schizophrenia 9.12.2008 89 08-080 Merck & Co. Inc. 0431C-102 A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control 12.12.2008 90 08-083 Merck Serono S.A. 28981 Double-blind extension of rhe study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patient with the first demyelinating event at high isk of converting to MS, treated with Rebif New Formulation (REFLEXION) 30.12.2008 91 09-001 Eli Lilly and Company F1J-MC-HMCK A double-blind, efficacy and safety study of duloxetine versus placebo in the treatment of children and adolescents with major depressive disorder 13.01.2009 92 09-002 CSL Behring GmbH CE1226_3001 An open, non-controlled, multicenter, multinational Study to evaluate the Efficacy and Safety of Zemaira® administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency who completed Clinical Study CE1226_4001 19.01.2009 93 09-006 Novartis Pharma AG CQAB149B2348 A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 ?g o.d. vs inhaled tiotropium 18 ?g o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD 25.02.2009 94 09-007 Novartis Pharma AG CTBM100C2303 A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). 13.02.2009 95 09-008 Schering-Plough Research Institute P04103 A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) 26.02.2009 96 09-011 Merck & Co. Inc. 0663-098 A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK-0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain
6.03.2009 97 09-012 Merck & Co. Inc. 0663-097 A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK-0663/Etoricoxib in the Treatment of Pain after Abdominal Hysterectomy 6.03.2009 98 09-013 Boehringer Ingelheim GmbH 1245.24 A 78 week open label extension to trials assessing the safety and efficacy of BI 10773 as monotherapy or in combination with Metformin in type 2 diabetic patients. 13.03.2009 99 09-014 Otsuka Pharmaceutical Development and Commercialization, Inc. 242-07-208 A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis 13.03.2009 100 09-016 Astellas Pharma Europe 150-CL-021 A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study to Investigate the Safety and Tolerability of YM150 in Subjects with Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability with Warfarin 27.03.2009 101 09-017 Astellas Pharma Europe 150-CL-040 A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery.
30.03.2009 102 09-018 IMPAX Laboratories, Inc. IPX066-B08-05 A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson"s Disease 9.04.2009 103 09-019 Millennium PharmaceuticalMillennium Pharmaceuticals, Inc. C13008 A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease 8.04.2009 104 09-020 Advanced BioHealing Inc ABH-DERMAGRAFT-001-08 A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers 14.04.2009 105 09-021 Merck & Co. Inc. 0653A-133 A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled with Simvastatin 20 mg or Atorvastatin 10 mg: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin (10mg/20mg) Versus Switching to Rosuvastatin 10mg or Doubling the Statin Dose 14.04.2009 106 09-022 Pierre Fabre Medicament L00070IN305B0 A phase III trial of vinflunine + capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant 15.04.2009 107 09-023 Novartis Pharma AG CFTY720D2301E1 An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. 20.04.2009 108 09-024 AstraZeneca AB D0810C00019 Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens 24.04.2009 109 09-026 Biogen Idec Limited 105MS301 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis 7.05.2009 110 09-030 Novartis Pharma Services CLAF237A23118 A multi-center, randomized, double-blind, placebo controlled clinical trial to evaluate the effect of 52 weeks treatment with vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure. 12.05.2009 111 09-031 Novartis Pharma AG CSPP100F2301 A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV) 12.05.2009 112 09-032 Sirtris Pharmaceuticals, Inc. SRT-2104-005 A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects 5.06.2009 113 09-033 Wyeth Research Division 3151A1-3360-WW A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder 8.06.2009 114 09-034 F. Hoffmann-La Roche Ltd. BO22227 A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC). 26.06.2009 115 09-035 Novartis Pharma AG CTBM100C2303E1 A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.
22.07.2009 116 09-036 Eisai Limited AS3201-G000-291 A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and
80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy23.07.2009 117 09-037 Lilly Corporate Center I2Y-MC-GHFA A Phase 2 Study for Transdermal Application of Teriparatide 23.07.2009 118 09-038 Boehringer Ingelheim Austria GmbH 1218.52 A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46 27.07.2009 119 09-039 Teva Pharmaceutical Industries, Ltd. MS-LAQ-301E A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis 4.08.2009 120 09-040 Tibotec BVBA TMC207-TiDP13-C209 A Phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB. 24.07.2009 121 09-041 Novartis Pharma AG CSBR759A2201 A 12-week, open label, multicenter, titration study, with a 9-month maintenance treatment extension, to demonstrate efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis 6.08.2009 122 09-042 GlaxoSmithKline Research & Development Ltd PKI113009 A six week randomized, double-blind, multi-center, placebocontrolled, exploratory, adaptive design study to explore the antidepressant properties of the p38 MAP kinase inhibitor GW856553 compared to placebo in adult subjects with Major Depressive Disorder. 10.08.2009 123 09-044 Biogen Idec Limited 109MS303 A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis 13.08.2009 124 09-045 sanofi-aventis recherche & développement EFC10781 A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin 7.08.2009 125 09-046 Amgen Limited 20060163 A Multicenter, Randomized, Double-blind Study Comparing De Novo Once
Monthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of
Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis14.08.2009 126 09-047 sanofi-aventis recherche & développement LTS6050 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 patients with multiple sclerosis with relapses 18.08.2009 127 09-048 F. Hoffmann La Roche AG ML18147 A randomized, open-label phase III Intergroup study: Effect of adding Bevacizumab to cross over fluoropyrimidine based chemotherapy (CTx) in patients with metastatic colorectal cancer and disease progression under first-line standard CTx / Bevacizumab combination. 18.08.2009 128 09-049 F. Hoffmann La Roche AG MO22324 A multicenter randomized phase II study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA) 18.08.2009 129 09-050 Amgen Inc. 20080009 A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone
Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of
Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)7.09.2009 130 09-051 Abbott Biologicals B.V S203.2.009 Randomized, Double-Blind, Active-Controlled Trial to Assess the Safety and Immunogenicity of Solvay"s Cell-Derived Influenza Vaccine, Including Revaccination, in Elderly subjects. 14.09.2009 131 09-052 Merck Serono S.A. 28850 Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson"s Disease Patients 14.09.2009 132 09-053 Institut de Recherches Internationales Servier CL3-16257-083 Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. 25.09.2009 133 09-054 SA TÜ Kliinikum 179 Pharmacokinetics of ertapenemin patients with severe sepsis and intraabdominal infection 2.10.2009 134 09-055 GlaxoSmithKline Research & Development Ltd HZC112206 A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (GW685698)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD) 16.10.2009 135 09-056 Novartis Pharma AG CACZ885H2356 A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective 14.10.2009 136 09-057 F. Hoffmann-La Roche Ltd NC25113 A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease 21.10.2009 137 09-058 MedImmune Ltd MI-CP219 A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis 22.10.2009 138 09-061 GlaxoSmithKline Research & Development Ltd FFS113203 A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older. 11.11.2009 139 09-062 Janssen-Cilag International NV 28431754DIA3008 A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus 13.11.2009 140 09-063 Pierre Fabre Medicament L00023 GE 303 EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS 18.11.2009 141 09-064 sanofi-aventis recherche & développement DFI5687 An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder. 1.12.2009 142 09-065 Merck & Co. Inc. 0653A-134 A Randomized, Double-Blind, Active-Controlled, Multicenter
Study of Patients with Primary Hypercholesterolemia and High
Cardiovascular Risk and not Adequately Controlled with Atorvastatin
20 mg: A Comparison of Switching to a Combination Tablet
Ezetimibe/Simvastatin (10mg/40mg) versus Doubling the Baseline
Dose to Atorvastatin 40 mg3.12.2009 143 09-066 Daiichi Sankyo Development Limited DU176b-D-U305 A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism 4.12.2009 144 09-067 Peptimmune Inc. CO-200-201 The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:
A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial7.12.2009 145 09-068 GlaxoSmithKline research & Development Limited AC4113589 A randomized, double-blind, parallel-group, placebo-controlled
study to evaluate the efficacy and safety of GSK573719
delivered once-daily over 28 days in subjects with COPD4.12.2009 146 09-069 Novartis Pharma AG CTBM100C2303E2 A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. 9.12.2009 147 09-070 Institut de Recherches Internationales Servier CL2-90098-009 Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder.
An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.17.12.2009 148 09-071 SA TÜK Psühhiaatriakliinik 7043 Investigation of genetic predictors of the response to SSRI treatment in patients with panic disorder 18.12.2009 149 09-072 SA TÜK Lastekliinik 1703 Meropenem pharmacokinetics in very low birth weight neonates 23.12.2009 150 09-073 Janssen-Cilag International N.V. R092670SCH3005 A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual with Oral Antipsychotics Monotherapy in Adults With Schizophrenia. 21.12.2009 151 09-074 sanofi-aventis recherche & développement EFC11072 A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy 29.12.2009 152 10-001 Merck Sharp & Dohme Corp. MK-0462-082 A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents 4.01.2010 153 10-003 F. Hoffmann-La Roche Ltd BO21004 An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities. 14.01.2010 154 10-004 Novartis Pharma AG CAIN457A2220 A randomized, double-blind, placebo controlled, multicenter dose ranging study of subcutaneously administered AIN457, assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis 18.01.2010 155 10-005 Bayer Healthcare AG BAY 59-7939/11702 Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. 9.02.2010 156 10-006 Teva Pharmaceutical Industries, Ltd. MS-LAQ-302E A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis 9.02.2010 157 10-007 sanofi-aventis recherche & développement EFC6204 Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy 19.02.2010 158 10-008 Janssen-Cilag International N.V. 28431754DIA3005 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise 26.02.2010 159 10-009 Novartis Pharma AG CACZ885H2356E1 A randomized, controlled extension study of CACZ885H2356 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective 1.03.2010 160 10-010 Pierre Fabre Medicament DC 0982 GE 203 1B Pharmacodynamic and clinical assessment of DC 982 GE (2,4 or 6 capsules per day) in patients with chronic venous disorders :
randomised, placebo-controlled, dose effect, double blind, parallel group study10.03.2010 161 10-011 Teva Pharmaceutical Industries, Ltd. MS-GA-301 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. 11.03.2010 162 10-012 GlaxoSmithKline Biologicals s.a. 113883 A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years. 19.03.2010 163 10-014 GlaxoSmithKline Research & Development Ltd HZC102871 A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) 30.03.2010 164 10-015 MacroGenics, Inc. CP-MGA031-02 A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus 26.03.2010 165 10-016 Novartis Pharma AG CQVA149A2304 A 52-week treatment, multi-center, randomized, double-blind,
parallel-group, active controlled study to evaluate the effect of
QVA149 (110/50 ?g o.d.) vs NVA237 (50 ?g o.d.) and open-label
tiotropium (18 ?g o.d.) on COPD exacerbations in patients with
severe to very severe chronic obstructive pulmonary disease
(COPD)1.04.2010 166 10-017 Tartu Ülikool 121 Hypobaric vs hyperbaric bupivacaine for spinal anaesthesia in total knee arthroplasty 9.04.2010 167 10-018 Novartis Pharma AG CACZ885H2357 A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective 25.03.2010 168 10-019 University Children"s Hospital Tübingen 223060 Efficacy and safety of Inhaled Budesonide in Very Preterm Infants at Risk of Brochopulmonary Dysplasia. 2.02.2010 169 10-020 Novartis Pharma AG CLCZ696B2314 A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction 23.04.2010 170 10-021 IMPAX Laboratories, Inc. IPX066-B09-03 An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease 20.04.2010 171 10-022 H. Lundbeck A/S 13267A A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of Lu AA21004 (15 and 20 mg/day) in the acute treatment of adult patients with Major Depressive Disorder. 20.04.2010 172 10-023 GlaxoSmithKline Biologicals s.a. 113369 A phase IIIB open, multicountry, randomized, controlled study to demonstrate the non-inferiority of the immune response of GSK Biologicals’ meningococcal serogroup A, C, W-135 and Y conjugate vaccine (MenACWY-TT) when given intramuscularly at 2, 4 and 12 months of age or given at 2, 3, 4 and 12 months of age compared to two licensed MenC conjugate vaccine given intramuscularly at 2, 4 and 12 months of age 30.04.2010 173 10-025 GW Pharma Ltd GWCA0958 A double blind, randomized, placebo-controlled, parallel group study of Sativex oromucosal spray (Sativex®; Nabiximols) in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. 14.05.2010 174 10-026 sanofi-aventis recherche & développement LTS11210 A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) 20.05.2010 175 10-027 Amgen Inc. 20080562 A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates. 20.05.2010 176 10-028 sanofi aventis DRONE_C_03668 A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AF 27.05.2010 177 10-029 Novartis Pharma AG CACZ885H2356E2 An open-label extension study of CACZ885H2356E1 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective 31.05.2010 178 10-030 Novartis Pharma AG CBGG492A2211 A 12-week, randomized, double-blind, placebo-controlled exploratory dose-titration study to assess the antiepileptic activity of BGG492 given orally three times daily (TID) as adjunctive treatment in patients with refractory partial onset seizures. 31.05.2010 179 10-031 Boehringer Ingelheim RCV 1264.3 A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by a 54 week blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg in type 2 diabetic patients with insufficient glycaemic control on diet and exercise 31.05.2010 180 10-032 Boehringer Ingelheim RCV 205.420 A Phase II, randomised, double- blind, placebo controlled, cross-over
efficacy and safety comparison of tiotropium 5 ?g administered once
daily (in the evening) and tiotropium 2.5 ?g administered twice daily
delivered by the Respimat® inhaler for four weeks versus placebo in patients with moderate persistent asthma9.06.2010 181 10-033 Janssen-Cilag International NV 28431754DIA3006 A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 (Canagliflozin) Compared with Sitagliptin and Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy. 15.06.2010 182 10-034 Novartis Pharma Services AG CAMN107EIC01 A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase 21.06.2010
Results