ReferenceType: background

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

family: le Roux

full_name: Carel le Roux

given: Carel

family: Aroda

full_name: Vanita Aroda

given: Vanita

family: Hemmingsson

full_name: Joanna Hemmingsson

given: Joanna

family: Cancino

full_name: Ana Paula Cancino

given: Ana Paula

family: Christensen

full_name: Rune Christensen

given: Rune

family: Pi-Sunyer

full_name: Xavier Pi-Sunyer

given: Xavier

currency_apc_doaj: CHF

journal_name: Obesity Facts

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422.

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. Epub 2016 Aug 2.

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

family: Fujioka

full_name: Ken Fujioka

given: Ken

name: Department of Psychiatry and Behavioral Sciences, Weight Management CenterMedical University of South CarolinaCharleston South Carolina USA

family: O'Neil

full_name: Patrick M. O'Neil

given: Patrick M.

name: Department of Health Sciences, Diabetes Research Centre, University of LeicesterLeicester UK

family: Davies

full_name: Melanie Davies

given: Melanie

name: Pennington Biomedical Research CenterBaton Rouge Louisiana USA

family: Greenway

full_name: Frank Greenway

given: Frank

name: Departments of Medicine, Biochemistry and Molecular Biology, University of Calgary Cumming School of MedicineCalgary Alberta Canada

family: C.W. Lau

full_name: David C.W. Lau

given: David

family: Claudius

full_name: Birgitte Claudius

given: Birgitte

family: Skjøth

full_name: Trine Vang Skjøth

given: Trine Vang

family: Bjørn Jensen

full_name: Christine Bjørn Jensen

given: Christine

name: Department of Obesity and Endocrinology, University of LiverpoolLiverpool UK.

family: P.H. Wilding

full_name: John P.H. Wilding

given: John

journal_name: Obesity

repository_institution: University of Leicester - Leicester Research Archive

title: Early Weight Loss with Liraglutide 3.0 mg Predicts 1‐Year Weight Loss and is Associated with Improvements in Clinical Markers

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

name: Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA;

name: New York Obesity Research Center, Columbia University, New York, NY, USA;

name: Capio St Goran’s Hospital/Karolinska Institutet, Stockholm, Sweden;

name: Department of Endocrinology, Diabetology and Metabolism, Faculty of Medicine, Antwerp University Hospital, Edegem, Belgium

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

name: Wake Forest School of Medicine, Wake Forest Baptist Medical Center; Winston-Salem NC USA

name: Endocrine Metabolic Associates; Philadelphia PA USA

name: Division of Preventive Medicine; University of Alabama at Birmingham; Birmingham AL USA

name: New York University School of Medicine; New York NY USA

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

name: Department of Obesity and Endocrinology; University of Liverpool; Liverpool UK

name: Medical Affairs, GLP-1 and Obesity; Novo Nordisk A/S; Søborg Denmark

name: Diabetes Complications Research Centre, Conway Institute; University College Dublin; Dublin Ireland

name: Investigative Science; Imperial College London; London UK

ReferenceCitation: Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjøth TV, Andreasen AH, Jensen CB, DeFronzo RA; NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):687-99. doi: 10.1001/jama.2015.9676. Erratum in: JAMA. 2016 Jan 5;315(1):90.

name: Diabetes Research Centre, University of Leicester, Leicester, United Kingdom

name: International Diabetes Center, Park Nicollet Health Services, Minneapolis, Minnesota

name: Atlanta Diabetes Associates, Atlanta, Georgia

name: Northwestern University, Chicago, Illinois

name: National Research Institute, Los Angeles, California

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review.

ReferenceCitation: Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4. Erratum in: Diabetes Care. 2018 Jul;41(7):1538.

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

journal_name: Journal of Diabetes and its Complications

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

name: Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina; Charleston South Carolina

name: Department of Internal Medicine, Endocrinology, Diabetes & Metabolism, MedStar Health Research Institute; Georgetown University School of Medicine; Hyattsville Maryland

name: Department of Nutrition, Exercise and Sports; University of Copenhagen; Frederiksberg C Denmark

name: Department of Internal Medicine, Northwestern University Feinberg School of Medicine; Chicago Illinois

name: Departments of Medicine and Biochemistry & Molecular Biology, University of Calgary Cumming School of Medicine; Calgary Alberta Canada

name: Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania; Philadelphia Pennsylvania

name: Novo Nordisk Inc.; Plainsboro New Jersey

name: Department of Obesity and Endocrinology, Obesity and Endocrinology Clinical Research Group; University of Liverpool; Liverpool UK

name: on behalf of the Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

name: Diabetes Research Centre; University of Leicester; Leicester UK

name: Weill-Cornell Medical Center; New York New York

name: Boden Institute, Charles Perkins Centre; University of Sydney; Sydney New South Wales Australia

name: Department of Medical and Science; Novo Nordisk A/S; Søborg Denmark

name: Department of Global Medical Affairs; Novo Nordisk A/S; Søborg Denmark

name: HCA Midwest Health Heart and Vascular Institute; Kansas City Missouri

title: Liraglutide and cardiovascular outcomes in adults with overweight or obesity: Apost hoc analysis from SCALE randomized controlled trials

location_country:
Italy
United States
South Africa
Sweden
India
France
Israel
Puerto Rico
Spain
Turkey
Germany
United Kingdom
Taiwan

title: Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.


type: Other Identifier

type: EudraCT Number

title: An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278

summary: The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Janssen R&D Ireland

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Thailand
Argentina
Canada
South Africa
Chile
Sweden
Netherlands
Puerto Rico
China
Germany
United Kingdom
United States
Austria
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of MP4OX Treatment, in Addition to Standard Treatment, in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

design_allocation: Randomized

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. Epub 2004 Jan 16.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Svergun DI, Ekström F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. Epub 2007 Sep 7.

ReferenceCitation: Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. Epub 2004 Jun 18.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. Epub 2006 Jul 20.

ReferenceCitation: Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. Epub 2003 Jun 12.

ReferenceCitation: Olofsson CI, Górecki AZ, Dirksen R, Kofranek I, Majewski JA, Mazurkiewicz T, Jahoda D, Fagrell B, Keipert PE, Hardiman YJ, Levy H; Study 6084 Clinical Investigators. Evaluation of MP4OX for prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia: a randomized, double-blind, multicenter study. Anesthesiology. 2011 May;114(5):1048-63. doi: 10.1097/ALN.0b013e318215e198.

ReferenceCitation: van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Górecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.

lead_sponsor: Sangart

location_country:
Austria
Brazil
South Africa
Switzerland
France
Israel
Norway
Singapore
Australia
New Zealand
Spain
Germany
United Kingdom
Colombia

location_facility: Faculdade de Medicina de S. J. Do Rio Preto

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt a.M.

location_facility: Hospital Universitário - USP Ribeirão Preto

location_facility: Centre Hospitalier Universitaire Vaudois CHUV


title: A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceType: derived

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

family: Esquenazi

full_name: Alberto Esquenazi

given: Alberto

sequence: first

family: Brashear

full_name: Allison Brashear

given: Allison

sequence: additional

name: Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire UCL  Yvoir Belgium

family: Deltombe

full_name: Thierry Deltombe

given: Thierry

name: Department of Neurology, Faculty of Medicine and Health Service Andrzej Frycz Modrzewski Krakow University  Krakow Poland

family: Rudzinska‐Bar

full_name: Monika Rudzinska‐Bar

given: Monika

name: Centrum Medyczne Plejady ul  Kraków Poland

family: Krawczyk

full_name: Malgorzata Krawczyk

given: Malgorzata

name: Pavlov First St Petersburg State Medical University  St Petersburg Russia

family: Skoromets

full_name: Alexander Skoromets

given: Alexander

name: Department of Rehabilitation Medicine Weill Cornell Medicine  New York NY USA

family: O'Dell

full_name: Michael W. O'Dell

given: Michael W.

family: Grandoulier

full_name: Anne‐Sophie Grandoulier

given: Anne‐Sophie

family: Vilain

full_name: Claire Vilain

given: Claire

family: Picaut

full_name: Philippe Picaut

given: Philippe

name: EA 7377 BIOTN, Université Paris‐Est Créteil, Service de Rééducation Neurolocomotrice, Hôpitaux Universitaires Henri Mondor  Créteil France

family: Gracies

full_name: Jean‐Michel Gracies

given: Jean‐Michel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PM&R

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

name: Department of Physical Medicine and RehabilitationMossRehab Gait and Motion Analysis Laboratory Elkins Park PA USA

name: Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint‐LucCatholic University of Louvain Brussels Belgium

family: Stoquart

full_name: Gaëtan Stoquart

given: Gaëtan

name: Department of Neurology, Division of Movement DisordersVanderbilt University Nashville TN USA

family: Hedera

full_name: Peter Hedera

given: Peter

name: Centro de Medicina de Reabilitação de Alcoitão, Estoril Estoril Portugal

family: Jacinto

full_name: Luis Jorge Jacinto

given: Luis Jorge

name: Division of Physical Medicine and Rehabilitation, Department of Surgical SciencesUniversity of Turin Turin Italy

family: Dimanico

full_name: Ugo Dimanico

given: Ugo

name: Unités de Médecine Physique et de Réadaptation, Hôpital SébastopolUniversité de Reims Champagne‐Ardenne Reims France

family: Constant‐Boyer

full_name: Francois Constant‐Boyer

given: Francois

name: School of MedicineUniversity of California Davis Sacramento CA

name: Department of NeurologyWake Forest School of Medicine Winston‐Salem NC

name: BiostatisticsIpsen Pharma Les Ulis France

name: Service de Rééducation NeurolocomotriceEA 7377 BIOTN, Université Paris‐Est, Hospital Albert Chenevier‐Henri Mondor Créteil France

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

ReferenceCitation: McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

repository_institution: Jagiellonian University - Jagiellonian University Repository

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Italy
France
Czechia
Poland
Slovakia
Hungary
Belgium
Australia
Russian Federation
Portugal
United States

location_facility: Wake Forest University Baptist Medical Center

location_facility: University of North Carolina - Chapel Hill

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Associated Neurologist of Southern CT, PC

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Scientific Research Institute of Neurology

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: The University of Texas Southwestern Medical Center at Dalla

location_facility: National Institute for Medical Rehabilitation

location_facility: Krakowska Akademia Neurologii Sp. z o.o.


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

summary:
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.

Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

ReferenceCitation: Armstrong AJ, Anand A, Edenbrandt L, Bondesson E, Bjartell A, Widmark A, Sternberg CN, Pili R, Tuvesson H, Nordle Ö, Carducci MA, Morris MJ. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951. doi: 10.1001/jamaoncol.2018.1093.

name: Division of Medical Oncology, Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina

name: Division of Urology, Department of Surgery, Duke Cancer Institute, Duke University, Durham, North Carolina

name: Department of Pharmacology and Cancer Biology, Duke Cancer Institute, Duke University, Durham, North Carolina

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

name: Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden

family: Anand

full_name: Aseem Anand

given: Aseem

name: Department of Nuclear Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden

family: Edenbrandt

full_name: Lars Edenbrandt

given: Lars

family: Bondesson

full_name: Eva Bondesson

given: Eva

family: Bjartell

full_name: Anders Bjartell

given: Anders

family: Widmark

full_name: Anders Widmark

family: Sternberg

full_name: Cora N. Sternberg

given: Cora N.

family: Pili

full_name: Roberto Pili

given: Roberto

family: Tuvesson

full_name: Helen Tuvesson

given: Helen

name: Nordle Biostatistical Consultancy, Rydebäck, Sweden

family: Nordle

full_name: Örjan Nordle

given: Örjan

name: The John Hopkins University School of Medicine, Baltimore, Maryland

family: Carducci

full_name: Michael A. Carducci

given: Michael A.

name: Memorial Sloan Kettering Cancer Center, New York, New York

name: Weill Cornell Medicine, New York, New York

family: Morris

full_name: Michael J. Morris

given: Michael J.

journal_name: JAMA Oncology

evidence: open (via free pdf)

evidence: oa repository (via OAI-PMH doi match)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bögemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. doi: 10.1200/JCO.2016.66.9697. Epub 2016 Jun 13.

name: Cora Sternberg, San Camillo Forlanini Hospitals, Rome, Italy; Andrew Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Roberto Pili, Indiana University School of Medicine, Indianapolis, IN; Siobhan Ng, St John of God Medical Centre, Subiaco, Western Australia, Australia; Robert Huddart, Royal Marsden Hospital, Sutton; Nicholas James, Queen Elizabeth Hospital, Birmingham; Simon Chowdhury, Guy’s Hospital and Sarah Cannon Research UK, London, United Kingdom; Neeraj Agarwal, University of Utah,...

full_name: Cora Sternberg

given: Cora

full_name: Andrew Armstrong

given: Andrew

family: Ng

full_name: Siobhan Ng

given: Siobhan

family: Huddart

full_name: Robert Huddart

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
France
Panama
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
Chile
Sweden
Netherlands
Bulgaria
China
Germany
United States
United Kingdom
Italy
Brazil
Lebanon
Mexico
Israel
New Zealand
Spain
Estonia
Latvia


title: AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY

summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

status: Terminated

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Belgium
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Thailand
Canada
Sweden
Bulgaria
Singapore
Hungary
Ireland
Puerto Rico
United States
Germany
United Kingdom
Mexico
Czechia
Spain

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: OU Medical Center Presbyterian Professional Building

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: University of Kentucky A.B. Chandler Medical Center

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Cliniques universitaires UCL de Mont-Godinne,

location_facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

location_facility: Hematology-Oncology Medical Group of Fresno Inc

location_facility: Klaipeda Seamen's Hospital, Public Institution, department of Oncology

location_facility: Regional Treatment and Diagnostic Hematology Center Communal Establishment

location_facility: Pathology Department Nottingham University Hospital - City Hospital Campus

location_facility: SBAL na Hematologichnichni Zabolyavania,CTH Sofia

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Department of Clinical Biochemistry Newcastle upon Tyne Hospitals

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont

location_facility: Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Pharmacy Nottingham University Hospital - City Hospital Campus

location_facility: Peggy and Charles Stephenson Cancer Center (chemo & infusion)

location_facility: Instituto Biomédico de Investigación A.C.

location_facility: Department of Medical Oncology St. Bartholomew's Hospital

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust

location_facility: Peggy and Charles Stephenson Cancer Center (clinic location)

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia

location_facility: Washington University School of Medicine

location_facility: Local Laboratory Nottingham University Hospital - City Hospital Campus

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University of Kentucky Markey Cancer Center

location_facility: Department of Oncology and Medical Radiology of State Institution

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Moscow State Healthcare Institution City clinical hospital S.P. Botkin

location_facility: Disney Family Cancer Center at Providence St Joseph Medical Center

location_facility: UMBAL Sveti Georgi, Klinika po hematologia

location_facility: Shands Hospital at the University of Florida

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: Baylor: Charles A. Sammons Cancer Center

location_facility: University Hospital Dubrava Department of Internal Medicine Division of Hematology

location_facility: Hospital Espanol Auxilio Mutuo de Puerto Rico Inc

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz /

location_facility: 21st Century Oncology of Jacksonville, LLC

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Barbara Ann Karmanos Cancer Institute at farmington Hills

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center

location_facility: SI"Research Center for Radiation Medicine of NAMS of Ukraine"

location_facility: OEC Record Management Company Pvt. Ltd.,

location_facility: Federal State Budgetary Institution Hematology Scientific Centre of Ministry of

location_facility: Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University

location_facility: UF Health Davis Cancer Pavillion and Shands Med Plaza

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa

location_facility: Chemotherapy Preparative Unit St. Bartholomew's Hospital

location_facility: 21st Century Oncology of Jacksonville, Inc.

status_simplified: Unknown


title: A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

summary: BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

ReferenceCitation: Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martín-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.

ReferenceCitation: Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbé C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Grob

full_name: Jean Jacques Grob

given: Jean Jacques

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Kiecker

full_name: Felix Kiecker

given: Felix

family: Dutriaux

full_name: Caroline Dutriaux

given: Caroline

family: Demidov

full_name: Lev V. Demidov

given: Lev V.

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Blank

full_name: Christian U. Blank

given: Christian U.

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Millward

full_name: Michael Millward

given: Michael

family: Kefford

full_name: Richard Kefford

given: Richard

family: Haas

full_name: Tomas Haas

given: Tomas

family: D'Amelio

full_name: Anthony D'Amelio

given: Anthony

suffix: Jr.

family: Gasal

full_name: Eduard Gasal

given: Eduard

family: Mookerjee

full_name: Bijoyesh Mookerjee

given: Bijoyesh

family: Chapman

full_name: Paul B. Chapman

given: Paul B.

journal_name: European Journal of Cancer

oa_host_type: repository

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Latimer NR, Abrams KR, Amonkar MM, Stapelkamp C, Swann RS. Adjusting for the Confounding Effects of Treatment Switching-The BREAK-3 Trial: Dabrafenib Versus Dacarbazine. Oncologist. 2015 Jul;20(7):798-805. doi: 10.1634/theoncologist.2014-0429. Epub 2015 Jun 3.

name: School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom;

name: Department of Health Sciences, University of Leicester, Leicester, United Kingdom;

name: GlaxoSmithKline, Collegeville, Pennsylvania, USA;

name: GlaxoSmithKline, Uxbridge, United Kingdom

title: Adjusting for the Confounding Effects of Treatment Switching—The BREAK‐3 Trial: Dabrafenib Versus Dacarbazine

ReferenceCitation: Grob JJ, Amonkar MM, Martin-Algarra S, Demidov LV, Goodman V, Grotzinger K, Haney P, Kämpgen E, Karaszewska B, Mauch C, Miller WH Jr, Millward M, Mirakhur B, Rutkowski P, Chiarion-Sileni V, Swann S, Hauschild A. Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine. Ann Oncol. 2014 Jul;25(7):1428-1436. doi: 10.1093/annonc/mdu154. Epub 2014 Apr 25.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

name: GlaxoSmithKline; Research Triangle Park; NC USA

title: Population pharmacokinetics of dabrafenib, a BRAF inhibitor: Effect of dose, time, covariates, and relationship with its metabolites

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Hungary
Australia
Ireland
Russian Federation
Spain
Canada


title: A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs

summary: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.

ReferenceCitation: Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Porter-Brown

full_name: Benjamin Porter-Brown

given: Benjamin

family: Thompson

full_name: Liz Thompson

given: Liz

family: Harari

full_name: Olivier Harari

given: Olivier

family: Dougados

full_name: Maxime Dougados

given: Maxime

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
South Africa
India
United Kingdom
Germany
France
Bulgaria
Lithuania
Poland
Slovakia
Belgium
Australia
Russian Federation
Spain
United States
Czech Republic
Canada


title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis

summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

ReferenceCitation: Vaclavkova A, Chimenti S, Arenberger P, Holló P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10.

family: Vaclavkova

full_name: Andrea Vaclavkova

given: Andrea

family: Chimenti

full_name: Sergio Chimenti

given: Sergio

family: Arenberger

full_name: Petr Arenberger

given: Petr

family: Holló

full_name: Peter Holló

given: Peter

family: Sator

full_name: Paul-Gunther Sator

given: Paul-Gunther

family: Burcklen

full_name: Michel Burcklen

given: Michel

family: Stefani

full_name: Mylène Stefani

given: Mylène

family: D'Ambrosio

full_name: Daniele D'Ambrosio

given: Daniele

journal_name: The Lancet

publisher_normalized: Elsevier

lead_sponsor: Actelion

location_country:
Italy
Austria
Sweden
Switzerland
United Kingdom
France
Bulgaria
Lithuania
Slovakia
Romania
Hungary
Belgium
Russian Federation
Spain
Denmark
Czech Republic
Ukraine

location_facility:
Clinical Investigative Site 2708
Clinical Investigative Site 2310
Clinical Investigative Site 1205
Clinical Investigative Site 2701
Clinical Investigative Site 1707
Clinical Investigative Site 3101
Clinical Investigative Site 1202
Clinical Investigative Site 1102
Clinical Investigative Site 2603
Clinical Investigative Site 3103
Clinical Investigative Site 1201
Clinical Investigative Site 1007
Clinical Investigative Site 2606
Clinical Investigative Site 2704
Clinical Investigative Site 1206
Clinical Investigative Site 2315
Clinical Investigative Site 2309
Clinical Investigative Site 1006
Clinical Investigative Site 2003
Clinical Investigative Site 1502
Clinical Investigative Site 2303
Clinical Investigative Site 3306
Clinical Investigative Site 2304
Clinical Investigative Site 1405
Clinical Investigative Site 2005
Clinical Investigative Site 1004
Clinical Investigative Site 3514
Clinical Investigative Site 2904
Clinical Investigative Site 2601
Clinical Investigative Site 2607
Clinical Investigative Site 2902
Clinical Investigative Site 2004
Clinical Investigative Site 3006
Clinical Investigative Site 1204
Clinical Investigative Site 3304
Clinical Investigative Site 1703
Clinical Investigative Site 1406
Clinical Investigative Site 1103
Clinical Investigative Site 3001
Clinical Investigative Site 1704
Clinical Investigative Site 1402
Clinical Investigative Site 2002
Clinical Investigative Site 2608
Clinical Investigative Site 3801
Clinical Investigative Site 1705
Clinical Investigative Site 1702
Clinical Investigative Site 2317
Clinical Investigative Site 2006
Clinical Investigative Site 3512
Clinical Investigative Site 2001
Clinical Investigative Site 2604
Clinical Investigative Site 1504
Clinical Investigative Site 2602
Clinical Investigative Site 2316
Clinical Investigative Site 2605
Clinical Investigative Site 2901
Clinical Investigative Site 1701
Clinical Investigative Site 1001
Clinical Investigative Site 1401
Clinical Investigative Site 2307
Clinical Investigative Site 1101
Clinical Investigative Site 3410
Clinical Investigative Site 2705
Clinical Investigative Site 1710
Clinical Investigative Site 1203
Clinical Investigative Site 1002
Clinical Investigative Site 2907


ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

name: Department of Renal Medicine; Royal Infirmary of Edinburgh; Edinburgh UK

family: Pugh

full_name: Dan Pugh

given: Dan

name: Centre for Inflammation Research; Royal Infirmary of Edinburgh; Edinburgh UK

family: O'Sullivan

full_name: Eoin D O'Sullivan

given: Eoin D

family: Duthie

full_name: Fiona AI Duthie

given: Fiona AI

name: Department of Renal Medicine; Royal Free London NHS Foundation Trust; London UK

family: Masson

full_name: Philip Masson

given: Philip

name: Renal Department; Newcastle University/Freeman Hospital; Newcastle Upon Tyne UK

family: Kavanagh

full_name: David Kavanagh

given: David

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Cofiell R, Kukreja A, Bedard K, Yan Y, Mickle AP, Ogawa M, Bedrosian CL, Faas SJ. Eculizumab reduces complement activation, inflammation, endothelial damage, thrombosis, and renal injury markers in aHUS. Blood. 2015 May 21;125(21):3253-62. doi: 10.1182/blood-2014-09-600411. Epub 2015 Apr 1.

name: Alexion Pharmaceuticals, Inc., Cheshire, CT

family: Cofiell

full_name: Roxanne Cofiell

given: Roxanne

family: Kukreja

full_name: Anjli Kukreja

given: Anjli

family: Bedard

full_name: Krystin Bedard

given: Krystin

family: Yan

full_name: Yan Yan

given: Yan

family: Mickle

full_name: Angela P. Mickle

given: Angela P.

family: Ogawa

full_name: Masayo Ogawa

given: Masayo

family: Bedrosian

full_name: Camille L. Bedrosian

given: Camille L.

family: Faas

full_name: Susan J. Faas

given: Susan J.

journal_name: Blood

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
United States
France
Belgium
Spain
Germany
United Kingdom

source: euctr

title: An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

summary: The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.


title: A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

ReferenceCitation: Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Rubbert-Roth

full_name: Andrea Rubbert-Roth

given: Andrea

family: Cantagrel

full_name: Alain Cantagrel

given: Alain

family: Hall

full_name: Stephen Hall

given: Stephen

family: Leszczynski

full_name: Piotr Leszczynski

given: Piotr

family: Feldman

full_name: Daniel Feldman

given: Daniel

family: Rangaraj

full_name: Madura J Rangaraj

given: Madura J

family: Roane

full_name: Georgia Roane

given: Georgia

family: Ludivico

full_name: Charles Ludivico

given: Charles

family: Bao

full_name: Min Bao

given: Min

family: Rowell

full_name: Lucy Rowell

given: Lucy

family: Davies

full_name: Claire Davies

given: Claire

family: Mysler

full_name: Eduardo F Mysler

given: Eduardo F

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

location_country:
Peru
Guatemala
Romania
Australia
Russian Federation
France
Poland
Lithuania
Thailand
Argentina
Canada
Colombia
South Africa
Hong Kong
Philippines
Bulgaria
Singapore
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Mexico
New Zealand
Spain


title: TRUSTS: A Phase IIB/III Multicenter Study Comparing the Efficacy of TRabectedin Administered as a 3-Hour or 24-Hour Infusion to Doxorubicin in Patients With Advanced or Metastatic Untreated Soft Tissue Sarcoma

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma.

PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.

study_completion_date_type: Anticipated

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Austria
Switzerland
Netherlands
Germany
France
Poland
Slovakia
Hungary
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: HôPITAUX UNIVERSITAIRES BORDET-ERASME - INSTITUT JULES BORDET

location_facility: Nhs Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

location_facility: Nottingham University Hospitals Nhs Trust - City Hospital Campus

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia

location_facility: ASSISTANCE PUBLIQUE - HôPITAUX DE MARSEILLE - HôPITAL DE LA TIMONE

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen

location_facility: Institut de Cancerologie de L'Ouest (Ico) - Centre Rene Gauducheau

location_facility: Erasmus Mc - Daniel Den Hoed Cancer Center

location_facility: Holden Comprehensive Cancer Center at University of Iowa

intervention_type: Other


title: 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-Dependence

acronym: RESUME

summary: The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)

ReferenceCitation: Tefferi A, Al-Ali HK, Barosi G, Devos T, Gisslinger H, Jiang Q, Kiladjian JJ, Mesa R, Passamonti F, McMullin MF, Ribrag V, Schiller G, Vannucchi AM, Zhou D, Reiser D, Zhong J, Gale RP. A randomized study of pomalidomide vs placebo in persons with myeloproliferative neoplasm-associated myelofibrosis and RBC-transfusion dependence. Leukemia. 2017 Apr;31(4):896-902. doi: 10.1038/leu.2016.300. Epub 2016 Oct 24. Erratum in: Leukemia. 2017 May;31(5):1252.

family: Tefferi

full_name: A Tefferi

given: A

family: Al-Ali

full_name: H K Al-Ali

given: H K

family: Barosi

full_name: G Barosi

given: G

family: Devos

full_name: T Devos

given: T

family: Gisslinger

full_name: H Gisslinger

given: H

family: Jiang

full_name: Q Jiang

given: Q

family: Kiladjian

full_name: J-J Kiladjian

given: J-J

family: Mesa

full_name: R Mesa

given: R

family: Passamonti

full_name: F Passamonti

given: F

family: Ribrag

full_name: V Ribrag

given: V

family: Schiller

full_name: G Schiller

family: Vannucchi

full_name: A M Vannucchi

given: A M

family: Zhou

full_name: D Zhou

given: D

family: Reiser

full_name: D Reiser

family: Zhong

full_name: J Zhong

given: J

family: Gale

full_name: R P Gale

given: R P

journal_name: Leukemia

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Begna KH, Pardanani A, Mesa R, Litzow MR, Hogan WJ, Hanson CA, Tefferi A. Long-term outcome of pomalidomide therapy in myelofibrosis. Am J Hematol. 2012 Jan;87(1):66-8. doi: 10.1002/ajh.22233. Epub 2011 Nov 12.

location_country:
Italy
Austria
United States
Sweden
Netherlands
Spain
Germany
France
Japan
Poland
Australia
Belgium
Russian Federation
China
Canada
United Kingdom

location_facility: Ospedale di Circolo e Fondazione Macchi Varese

location_facility: IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Ematologia

location_facility: Hospital Universitario Puerta De Hierro Majadahonda

location_facility: Mount Sinai School of Medicine Brookdale University Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 PAM

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Federico II di Napoli

location_facility: Wojewodzki Szpital Specjalistyczny im. F.Chopina

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Federal State Institution "Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies named after V.A. Almazov"

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

location_facility: University of Florida Shands Cancer Center

location_facility: Federal State Institution Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-Biological Agency of Russia

location_facility: Weill Medical College of Cornell University

location_facility: Hopitaux Universitaires de Strasbourg, CHU Haute-Pierre

location_facility: Blood Disease Hospital Chinese Academy of Medical Sciences

location_facility: IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Centro per lo Studio della Mielofibrosi

location_facility: Universitaire Ziekenhuis Leuven Gathuisberg


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury

acronym: SyNAPSe

summary: The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

ReferenceCitation: Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. Epub 2006 Sep 29.

ReferenceCitation: Xiao G, Wei J, Yan W, Wang W, Lu Z. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Crit Care. 2008;12(2):R61. doi: 10.1186/cc6887. Epub 2008 Apr 30.

ReferenceCitation: Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N; SYNAPSE Trial Investigators. A clinical trial of progesterone for severe traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2467-76. doi: 10.1056/NEJMoa1411090. Epub 2014 Dec 10.

family: Skolnick

full_name: Brett E. Skolnick

given: Brett E.

family: Maas

full_name: Andrew I. Maas

given: Andrew I.

family: Narayan

full_name: Raj K. Narayan

given: Raj K.

family: van der Hoop

full_name: Roland Gerritsen van der Hoop

given: Roland Gerritsen

family: MacAllister

full_name: Thomas MacAllister

given: Thomas

family: Ward

full_name: John D. Ward

given: John D.

family: Nelson

full_name: Neta R. Nelson

given: Neta R.

family: Stocchetti

full_name: Nino Stocchetti

given: Nino

journal_name: New England Journal of Medicine

oa_colors: green other

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Tampere University - Tampere University Institutional Repository

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: A Clinical Trial of Progesterone for Severe Traumatic Brain Injury

lead_sponsor: BHR Pharma, LLC

location_country:
Finland
Malaysia
Romania
Belgium
Russian Federation
Czech Republic
Taiwan
France
Thailand
Argentina
Netherlands
Singapore
Hungary
China
Germany
United Kingdom
United States
Italy
Austria
Israel
Spain

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Universitätsklinikum Gießen und Marburg gGmbH

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario de Girona Dr. Josep Trueta

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ

location_facility: State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: The Second Hospital of Shandong University

location_facility: State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of South Carolina School of Medicine

location_facility: Wake Forest University-Baptist Medical Center

location_facility: General Hospital of Tianjin Medical University

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Azienda Ospedaliero Universitaria Integrata di Verona

location_facility: Azienda Ospedaliero Universitaria Maggiore della Caritá

location_facility: Ziekenhuis Oost-Limburg, Location Sint Jan

location_facility: University of California San Diego Medical Center

location_facility: Hospital Regional De Comodoro Rivadavia (HRCR)

location_facility: Hospital Nacional "Profesor Alejandro Posadas"

location_facility: Faculty of Medicine, Prince of Songkla University

location_facility: Saint Petersburg Healthcare Institution "City Mariinsky Hospital"

location_facility: State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: The 2nd Affiliated Hospital of Zhejiang University

location_facility: Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení

location_facility: Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika

location_facility: State Institution "Burdenko Neurosurgical Institute of RAMS"

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Grenoble- Hópital Michallon

location_facility: Texas Tech University Health Sciences Center

location_facility: Hospital Clínico Universitario De Valencia

location_facility: State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"

location_facility: Hospital de Emergencias Clemente Alvarez (HECA)

location_facility: University of South Alabama Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: University Hospital of the Free University Brussels (UZ Brussel)

location_facility: Leeds Teaching Hospitals NHS, Leeds General Infirmary

location_facility: Hospital Universitari i Politecnic La Fé de Valencia

location_facility: Fakultní nemocnice Brno Neurochirurgická klinika


title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

family: Cai

full_name: Jennifer Cai

given: Jennifer

family: Delahanty

full_name: Linda M. Delahanty

given: Linda M.

family: Akapame

full_name: Sydney Akapame

given: Sydney

family: Slee

full_name: April Slee

given: April

family: Traina

full_name: Shana Traina

given: Shana

journal_name: The Patient - Patient-Centered Outcomes Research

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

name: Janssen Research & Development, LLC, Raritan, NJ, USA;

family: Qiu

full_name: Rong Qiu

given: Rong

family: Balis

full_name: Dainius Balis

given: Dainius

family: Xie

full_name: John Xie

given: John

name: Janssen Scientific Affairs, LLC, Raritan, NJ, USA

family: Davies

full_name: Michael J. Davies

given: Michael J.

family: Desai

full_name: Mehul Desai

given: Mehul

family: Meininger

full_name: Gary Meininger

given: Gary

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Schernthaner G, Lavalle-González FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. Epub 2016 Jul 26.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

family: Watts

full_name: Nelson B. Watts

given: Nelson B.

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Lavalle-González FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

name: aUniversidad Autonoma de Nuevo Leon, Monterrey, Mexico

name: bHospital Israelita Albert Einstein and CPClin Clinical Research Center, São Paulo, Brazil

name: cHospital Cima, Centro de Investigacíon Clínica San Agustín, San José, Costa Rica

name: dEndocrinología, Medicina Interna, Bogota, Colombia

name: eJanssen Research & Development, LLC, Raritan, NJ, USA

ReferenceCitation: Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

ReferenceCitation: Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

ReferenceCitation: Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013 Sep;36(9):2508-15. doi: 10.2337/dc12-2491. Epub 2013 Apr 5. Erratum in: Diabetes Care. 2013 Dec;36(12):4172.

title: Canagliflozin Compared With Sitagliptin for Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With Metformin Plus Sulfonylurea

location_country:
Austria
United States
Brazil
India
Netherlands
Germany
France
Malaysia
Poland
Israel
Singapore
Belgium
New Zealand
Denmark
Canada
Korea, Republic of
Ukraine


ReferenceCitation: Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Böcher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Mantry

full_name: Parvez Mantry

given: Parvez

family: Soriano

full_name: Vicente Soriano

given: Vicente

family: Buynak

full_name: Robert J. Buynak

given: Robert J.

family: Dufour

full_name: Jean-François Dufour

given: Jean-François

family: Pockros

full_name: Paul J. Pockros

given: Paul J.

family: Wright

full_name: David Wright

given: David

family: Angus

full_name: Peter Angus

given: Peter

family: Buti

full_name: Maria Buti

given: Maria

family: Stern

full_name: Jerry O. Stern

given: Jerry O.

family: Kadus

full_name: Werner Kadus

given: Werner

family: Vinisko

full_name: Richard Vinisko

given: Richard

family: Böcher

full_name: Wulf Böcher

given: Wulf

family: Mensa

full_name: Federico J. Mensa

given: Federico J.

journal_name: European Journal of Gastroenterology & Hepatology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Short article

ReferenceCitation: Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Müllhaupt B, Schuchmann M, Bourlière M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Böcher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Lohse

full_name: Ansgar W. Lohse

given: Ansgar W.

family: Müllhaupt

full_name: Beat Müllhaupt

given: Beat

family: Schuchmann

full_name: Marcus Schuchmann

given: Marcus

family: Bourlière

full_name: Marc Bourlière

given: Marc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Müllhaupt B, Roberts S, Schuchmann M, Manns M, Bourlière M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Böcher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.

title: Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

ReferenceCitation: Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Müllhaupt B, Schuchmann M, Bourlière M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Böcher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.

title: Faldaprevir and Deleobuvir for HCV Genotype 1 Infection

ReferenceCitation: Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Müllhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Böcher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.

title: Faldaprevir (BI 201335), BI 207127 and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results

location_country:
Austria
Switzerland
Spain
Germany
France
Romania
Australia
New Zealand
Portugal
United States

location_facility: 1241.21.0019 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0011 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0017 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.61002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0013 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35102 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0012 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.64001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.61001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35105 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0010 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43003 Boehringer Ingelheim Investigational Site

title: Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)

summary:
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)


title: A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder

summary: The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

ReferenceCitation: Newcorn JH, Harpin V, Huss M, Lyne A, Sikirica V, Johnson M, Ramos-Quiroga JA, van Stralen J, Dutray B, Sreckovic S, Bloomfield R, Robertson B. Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study. J Child Psychol Psychiatry. 2016 Jun;57(6):717-28. doi: 10.1111/jcpp.12492. Epub 2016 Feb 12.

name: Icahn School of Medicine at Mount Sinai New York NY USA

family: Newcorn

full_name: Jeffrey H. Newcorn

given: Jeffrey H.

name: Ryegate Children's Centre Sheffield NHS Foundation Trust Sheffield UK

family: Harpin

full_name: Valerie Harpin

given: Valerie

name: Johannes Gutenberg‐University Mainz Mainz Germany

family: Huss

full_name: Michael Huss

given: Michael

family: Lyne

full_name: Andrew Lyne

given: Andrew

family: Sikirica

full_name: Vanja Sikirica

given: Vanja

name: Gillberg Neuropsychiatry Centre University of Gothenburg Gothenburg Sweden

family: Johnson

full_name: Mats Johnson

given: Mats

name: Department of Psychiatry CIBERSAM Hospital Universitari Vall d'Hebron BarcelonaSpain

name: Department of Psychiatry and Forensic Medicine Universitat Autònoma de Barcelona Barcelona Spain

family: Ramos‐Quiroga

full_name: Josep Antoni Ramos‐Quiroga

given: Josep Antoni

name: Center for Pediatric Excellence Ottawa ON Canada

family: Stralen

full_name: Judy Stralen

given: Judy

name: Centre Hospitalier de Rouffach Rouffach France

family: Dutray

full_name: Benoit Dutray

given: Benoit

family: Sreckovic

full_name: Sasha Sreckovic

given: Sasha

family: Bloomfield

full_name: Ralph Bloomfield

given: Ralph

family: Robertson

full_name: Brigitte Robertson

given: Brigitte

journal_name: Journal of Child Psychology and Psychiatry

oa_host_type: publisher

title: Extended‐release guanfacine hydrochloride in 6–17‐year olds with ADHD: a randomised‐withdrawal maintenance of efficacy study

lead_sponsor: Shire

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Praxis Dr. med. Dipl. Psych. Anton Lindermüller

location_facility: Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA

location_facility: Encompass Clinical Research - North Coast

location_facility: Hopital Gatien de Clocheville CHU de Tours

location_facility: Center for Psychiatry and Behavioral Medicine, Inc.

location_facility: Centre Hospitalier Universitaire d'Amiens, Hôpital Nord

location_facility: Norfolk Community Health and Care NHS Trust

location_facility: Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie

location_facility: Children's and Women's Health Centre of British Columbia

location_facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

location_facility: Klinikum der Johannes-Gutenberg-Universität Mainz

location_facility: Centenary House Child and Adolescent Mental Health Services

location_facility: Ziekenhuis Inkendaal Koninklijke Instelling v.z.w.

location_facility: Centre de référence Neuropédiatrique Multidisciplinaire

location_facility: Hopital Robert Debre Centre pediatrique des pathologies du sommeil

location_facility: Instituto Valenciano de Neurología Pediatrica

location_facility: Psychiatric Centers at San Diego, Feighner Research

location_facility: Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS

location_facility: JPM van Stralen Medicine Professional Corporation

location_facility: Hopitaux Pediatriques de Nice - CHI Lenval

location_facility: Centre Hospitalier Universitaire Bocage-Hôpital d'enfants

location_facility: Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers


ReferenceType: result

ReferenceCitation: Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: DeVries

full_name: J Hans DeVries

given: J Hans

family: Bode

full_name: Bruce Bode

given: Bruce

family: Russell-Jones

full_name: David Russell-Jones

given: David

family: Leiter

full_name: Lawrence A Leiter

given: Lawrence A

family: Moses

full_name: Alan Moses

given: Alan

family: Johansen

full_name: Thue Johansen

given: Thue

family: Ratner

full_name: Robert Ratner

given: Robert

journal_name: The Lancet Diabetes & Endocrinology

lead_sponsor: Novo Nordisk A/S

location_country:
Netherlands
France
Bulgaria
Romania
Hungary
United States
Canada

acronym: BEGIN™

title: A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

summary: This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).


ReferenceCitation: McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.

family: McMahon

full_name: Chris G. McMahon

given: Chris G.

family: Giuliano

full_name: Francois Giuliano

given: Francois

family: Dean

full_name: John Dean

given: John

family: Hellstrom

full_name: Wayne J.G. Hellstrom

given: Wayne J.G.

family: Bull

full_name: Scott Bull

given: Scott

family: Tesfaye

full_name: Fisseha Tesfaye

given: Fisseha

family: Sharma

full_name: Om Sharma

given: Om

family: Rivas

full_name: David A. Rivas

given: David A.

family: Aquilina

full_name: Joseph W. Aquilina

given: Joseph W.

journal_name: The Journal of Sexual Medicine

title: Efficacy and Safety of Dapoxetine in Men with Premature Ejaculation and Concomitant Erectile Dysfunction Treated with a Phosphodiesterase Type 5 Inhibitor: Randomized, Placebo-Controlled, Phase III Study

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
United States
Mexico
France
Malaysia
Poland
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: COUPLE

title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor

summary: The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.


title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer

summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

ReferenceCitation: Van Cutsem E, Bang YJ, Feng-Yi F, Xu JM, Lee KW, Jiao SC, Chong JL, López-Sanchez RI, Price T, Gladkov O, Stoss O, Hill J, Ng V, Lehle M, Thomas M, Kiermaier A, Rüschoff J. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015 Jul;18(3):476-84. doi: 10.1007/s10120-014-0402-y. Epub 2014 Jul 20.

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

family: Feng-yi

full_name: Feng Feng-yi

given: Feng

family: Xu

full_name: Jian M. Xu

given: Jian M.

family: Lee

full_name: Keun-Wook Lee

given: Keun-Wook

family: Jiao

full_name: Shun-Chang Jiao

given: Shun-Chang

family: Chong

full_name: Jorge León Chong

given: Jorge León

family: López-Sanchez

full_name: Roberto I. López-Sanchez

given: Roberto I.

family: Price

full_name: Timothy Price

given: Timothy

family: Gladkov

full_name: Oleg Gladkov

given: Oleg

family: Stoss

full_name: Oliver Stoss

given: Oliver

family: Hill

full_name: Julie Hill

given: Julie

family: Ng

full_name: Vivian Ng

given: Vivian

family: Lehle

full_name: Michaela Lehle

given: Michaela

family: Thomas

full_name: Marlene Thomas

given: Marlene

family: Kiermaier

full_name: Astrid Kiermaier

given: Astrid

family: Rüschoff

full_name: Josef Rüschoff

given: Josef

journal_name: Gastric Cancer

license: implied-oa

license_normalized: implied-oa

ReferenceCitation: Satoh T, Bang YJ, Gotovkin EA, Hamamoto Y, Kang YK, Moiseyenko VM, Ohtsu A, Van Cutsem E, Al-Sakaff N, Urspruch A, Hill J, Weber HA, Chung HC; ToGA Trial Investigators. Quality of life in the trastuzumab for gastric cancer trial. Oncologist. 2014 Jul;19(7):712-9. doi: 10.1634/theoncologist.2014-0058. Epub 2014 Jun 20.

name: Osaka University Graduate School of Medicine, Osaka, Japan;

name: Seoul National University College of Medicine, Seoul, Republic of Korea;

name: Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation;

name: Tochigi Cancer Center, Utsunomiya, Japan;

name: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;

name: Institute of Oncology, St. Petersburg, Russian Federation;

name: National Cancer Center Hospital East, Kashiwa, Japan;

name: University Hospital Gasthuisberg, Leuven, Belgium;

name: F. Hoffmann‐La Roche Ltd., Basel, Switzerland;

name: Roche Products, Sydney, New South Wales, Australia;

name: Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

title: Quality of Life in the Trastuzumab for Gastric Cancer Trial

ReferenceCitation: Satoh T, Omuro Y, Sasaki Y, Hamamoto Y, Boku N, Tamura T, Ohtsu A. Pharmacokinetic analysis of capecitabine and cisplatin in combination with trastuzumab in Japanese patients with advanced HER2-positive gastric cancer. Cancer Chemother Pharmacol. 2012 Apr;69(4):949-55. doi: 10.1007/s00280-011-1783-9. Epub 2011 Nov 25.

ReferenceCitation: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum in: Lancet. 2010 Oct 16;376(9749):1302.

location_country:
Peru
Guatemala
Finland
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
Costa Rica
France
Japan
Panama
Korea, Republic of
South Africa
China
Portugal
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey


title: 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

acronym: AGATE

summary:
Primary Objective:

To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
To evaluate plasma concentrations of SSR125543

enrollment_type: Anticipated

lead_sponsor: Sanofi

location_country:
South Africa
Chile
Sweden
Netherlands
Germany
Finland
France
Slovakia
Belgium
Russian Federation
Estonia
Canada

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 152008

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 710004

location_facility: Sanofi-Aventis Investigational Site Number 152003

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 246005

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 233004

location_facility: Sanofi-Aventis Investigational Site Number 152007

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 643011

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 752004

location_facility: Sanofi-Aventis Investigational Site Number 246003

location_facility: Sanofi-Aventis Investigational Site Number 124009

location_facility: Sanofi-Aventis Investigational Site Number 703105

location_facility: Sanofi-Aventis Investigational Site Number 152005

location_facility: Sanofi-Aventis Investigational Site Number 276003

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 246002

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 703101

location_facility: Sanofi-Aventis Investigational Site Number 246004

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 124004

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 124008

location_facility: Sanofi-Aventis Investigational Site Number 152004

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 233003

location_facility: Sanofi-Aventis Investigational Site Number 752005

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 703104

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 703103

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 124011

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 124012

location_facility: Sanofi-Aventis Investigational Site Number 643010

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 276007

location_facility: Sanofi-Aventis Investigational Site Number 246001

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 643009

location_facility: Sanofi-Aventis Investigational Site Number 703102

location_facility: Sanofi-Aventis Investigational Site Number 710002

location_facility: Sanofi-Aventis Investigational Site Number 276008

location_facility: Sanofi-Aventis Investigational Site Number 152006