acronym: BEGIN™

title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.

ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

ReferenceCitation: Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.

ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014. Review.

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. Review.

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

location_country:
United Kingdom
Ireland
Russian Federation
Canada
Ukraine
United States
France
South Africa

summary: This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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.

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Brazil
Romania
Spain
Latvia
Russian Federation
Australia
Mexico
Canada
New Zealand
Korea, Republic of
United States
France
India
Malaysia
Belgium
South Africa
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years

lead_sponsor: Hoffmann-La Roche

source: euctr

location_country:
Denmark
Poland
Spain
Italy
Lithuania
Hungary
United States
France
Romania

summary: This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.


acronym: BOOST™

title: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

type: EudraCT Number

ReferenceCitation: Freemantle N, Mamdani M, Vilsbøll T, Kongsø JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. Epub 2015 Nov 18.

ReferenceCitation: Kumar S, Jang HC, Demirağ NG, Skjøth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.

ReferenceCitation: Yang W, Akhtar S, Franek E, Haluzík M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

location_country:
Croatia
Poland
Korea, Republic of
India
United States
France
Turkey
South Africa
Sweden

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.


title: Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

ReferenceCitation: McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.

ReferenceCitation: Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.

lead_sponsor: Bristol-Myers Squibb

location_country:
Puerto Rico
United States
France

location_facility: University Of Colorado Denver & Hospital


title: A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

summary: This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

study_start_date_type: Actual

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A, Dimonaco S. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016 Jun;75(6):1081-91. doi: 10.1136/annrheumdis-2015-207628. Epub 2015 Oct 28.

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Reumatologia

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Hospital de Sao Joao; Servico de Reumatologia

location_facility: Sunshine Coast Rheumatology Research Unit

location_facility: ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)

location_facility: Arthritis Health Associates; Clinical Research

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Addenbrooke'S Hospital; Rheumatology Research Unit

location_facility: Clnical & Translational Reseach Center for Alabama, PC

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Karolinska Sjukhuset; Reumatologkliniken D2-1

location_facility: Hopital Maisonneuve- Rosemont; Rheumatology

location_facility: Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia

location_facility: Clinic of Rheumatology; Clinical Centre Skopje

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia

location_facility: Phramongkutklao Hospital; Dept. of Medicine, Rheumatology

location_facility: Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Clinica Medica Del Dr Eduardo Alfredo Samayoa

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica

location_facility: FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Inst. de Rehabilitacion Psicofisica; Reumathology

location_facility: Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Hopital Porte Madeleine; Service de Rhumatologie

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Pamela Youde Nethersole Eastern Hospital; Department of Medicine

location_facility: Markhot Ferenc Hospital; Dep. of Rheumatology

location_facility: Haywood Hospital; Staffordshire Rheumatology Centre

location_facility: Royal Hallamshire Hospital; Rheumatology

location_facility: Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

location_facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214

location_facility: SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department

location_facility: Hadassah University Hospital, Ein Karem; Rheumatology

location_facility: Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: St. Joseph'S Health Care Centre; Rheumatology

location_facility: Hadassah Mount Scopus Hospital; Rheumatology

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

location_facility: Hospital Universitario de la Princesa; Servicio de Reumatologia

location_facility: State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: Chulalongkorn Hospital; Division of Rheumatology - Medicine

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Kaiser Franz Josef Spital; Ii. Medizinische Abt.

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: Karolinska University Hospital, Huddinge; Rheumatology

location_facility: Philippine General Hospital; Rheumatology

location_facility: Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Royal Prince Alfred Hospital; Rheumatology

location_facility: Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie

location_facility: FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"

location_facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

location_facility: Adelaide and Meath Hospital; Rheumatology Department

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach

location_facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii

location_facility: Rheumatology Associates of North Alabama

location_facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

location_facility: Istituto Ortopedico Rizzoli; Unità di Reumatologia

location_facility: State institution of healthcare "Regional hospital for war veterans"

location_facility: Hospital Univ. Central de Asturias; Servicio de Reumatologia

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology

location_facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Maidstone Hospital; Dept of Rheumatology

location_facility: Centro Internacional de Pesquisa; Reumatologia

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

location_facility: Helsinki University Central Hospital; Rheumatology Clinic

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: St.Vincent's University Hospital; Rheumatology Department

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

location_facility: Southwest Rheumatology & Research Group, LLC

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas

location_facility: Hospital de Santa Maria; Servico de Reumatologia

location_facility: National University Hospital; Dept of Medicine

location_facility: Centro Paulista de Investigacao Clinica - CEPIC

location_facility: Arthritis & Osteoporosis Associates, LLP

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: The Third Affiliated Hospital of Sun Yat-Sen University

location_facility: Waikato Hospital; Rheumatology Outpatients

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow

location_facility: Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Ohio State University; Dept of Immunology

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

location_facility: Uni of Santo Tomas Hospital; Rheumatology

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Chaim Sheba Medical Center; Interna Dept B

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia

location_facility: Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: Uni of California - San Diego; Division of Rheumatology

location_facility: Campus Bio-Medico; Immunologia e Allergologia

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Centro de Investigación Clínica de Morelia, S.C.; Reumatologia

location_facility: Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"

location_facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia

location_facility: QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology

location_facility: North Shore Hospital, STAR Unit; Rheumatology Department

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: Royal Victoria Infirmary; Clinical Research Facility

location_facility: State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"

location_facility: Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie

location_facility: Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica

location_facility: Arthrocare, Arthritis Care and Research, P.C.

location_facility: North Mississippi Medical Ctr; Internal Medicine Associates


title: A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

acronym: GENERATION

summary: This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

ReferenceCitation: Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on β-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.

ReferenceCitation: Schernthaner G, Durán-Garcia S, Hanefeld M, Langslet G, Niskanen L, Östgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.

lead_sponsor: AstraZeneca

location_country:
Denmark
Spain
Greece
Austria
Italy
United Kingdom
Finland
Sweden
Hungary
France
Mexico
Norway
Germany


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: PROMPT

summary: The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

ReferenceCitation: Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jörgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

location_country:
Spain
Italy
United Kingdom
France
Turkey
Belgium
Germany


title: A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms

summary: This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

ReferenceCitation: Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, García MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.

lead_sponsor: Bayer

location_country:
United States
Spain
France


primary_purpose: Prevention

acronym: ALPHEE

title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

lead_sponsor: Sanofi

ReferenceCitation: Kowey PR, Crijns HJ, Aliot EM, Capucci A, Kulakowski P, Radzik D, Roy D, Connolly SJ, Hohnloser SH; ALPHEE Study Investigators. Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study. Circulation. 2011 Dec 13;124(24):2649-60. doi: 10.1161/CIRCULATIONAHA.111.072561. Epub 2011 Nov 14.

location_country:
Spain
Italy
United States
Belgium
Japan
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
Finland
Czech Republic
France
Chile
Netherlands

location_facility:
Investigational Site Number 616008
Investigational Site Number 056002
Investigational Site Number 392006
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 620005
Investigational Site Number 840022
Investigational Site Number 392003
Investigational Site Number 840012
Investigational Site Number 032003
Investigational Site Number 840030
Investigational Site Number 056005
Investigational Site Number 643007
Investigational Site Number 840013
Investigational Site Number 036013
Investigational Site Number 036010
Investigational Site Number 376002
Investigational Site Number 392004
Investigational Site Number 840024
Investigational Site Number 528004
Investigational Site Number 724003
Investigational Site Number 620004
Investigational Site Number 528001
Investigational Site Number 528005
Investigational Site Number 578003
Investigational Site Number 724009
Investigational Site Number 380007
Investigational Site Number 840045
Investigational Site Number 620003
Investigational Site Number 124001
Investigational Site Number 056007
Investigational Site Number 208001
Investigational Site Number 250007
Investigational Site Number 724004
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 250001
Investigational Site Number 124006
Investigational Site Number 792001
Investigational Site Number 056004
Investigational Site Number 250003
Investigational Site Number 376001
Investigational Site Number 036012
Investigational Site Number 616002
Investigational Site Number 036009
Investigational Site Number 032004
Investigational Site Number 036008
Investigational Site Number 616011
Investigational Site Number 840004
Investigational Site Number 376003
Investigational Site Number 703001
Investigational Site Number 348003
Investigational Site Number 840025
Investigational Site Number 203006
Investigational Site Number 276005
Investigational Site Number 203005
Investigational Site Number 840033
Investigational Site Number 246001
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 616007
Investigational Site Number 752002
Investigational Site Number 840026
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 792002
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 124005
Investigational Site Number 840037
Investigational Site Number 376004
Investigational Site Number 208002
Investigational Site Number 203002
Investigational Site Number 840048
Investigational Site Number 643011
Investigational Site Number 840029
Investigational Site Number 643003
Investigational Site Number 528002
Investigational Site Number 392005
Investigational Site Number 840020
Investigational Site Number 032002
Investigational Site Number 152001
Investigational Site Number 124009
Investigational Site Number 616001
Investigational Site Number 840031
Investigational Site Number 392001
Investigational Site Number 528007
Investigational Site Number 348005
Investigational Site Number 840042
Investigational Site Number 840038
Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 840011
Investigational Site Number 203004
Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 036007
Investigational Site Number 036003
Investigational Site Number 752003
Investigational Site Number 840015
Investigational Site Number 484002
Investigational Site Number 036006
Investigational Site Number 276002
Investigational Site Number 276006
Investigational Site Number 380008
Investigational Site Number 724007
Investigational Site Number 840017
Investigational Site Number 792003
Investigational Site Number 643008
Investigational Site Number 840016
Investigational Site Number 380002
Investigational Site Number 752001
Investigational Site Number 528003
Investigational Site Number 840019
Investigational Site Number 208004
Investigational Site Number 840035
Investigational Site Number 380001
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840054
Investigational Site Number 840039
Investigational Site Number 840034
Investigational Site Number 036014
Investigational Site Number 124008
Investigational Site Number 246004
Investigational Site Number 208005
Investigational Site Number 392002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 840043
Investigational Site Number 643005
Investigational Site Number 840009
Investigational Site Number 616006
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 124007
Investigational Site Number 036005
Investigational Site Number 203001
Investigational Site Number 710002
Investigational Site Number 643004
Investigational Site Number 056001
Investigational Site Number 840049
Investigational Site Number 703002
Investigational Site Number 348001
Investigational Site Number 056003
Investigational Site Number 840005
Investigational Site Number 036004
Investigational Site Number 203003
Investigational Site Number 348004
Investigational Site Number 124010

summary:
The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary objectives were:

To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.
To document Celivarone plasma levels during the study.


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects

acronym: FITNESS

summary: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

ReferenceCitation: Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.

lead_sponsor: Pfizer

location_country:
Spain
Canada
Hungary
Korea, Republic of
United States
France
Puerto Rico
Belgium
Germany


title: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. Review.

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

ReferenceCitation: Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjøth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.

location_country:
Denmark
Serbia
Slovenia
Spain
Austria
Canada
Czech Republic
Finland
Former Serbia and Montenegro
Puerto Rico
United States
France
Belgium
Norway
Germany

summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.


title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

acronym: START rollover

summary: This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

design_allocation: Non-Randomized

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Poland
Russian Federation
Australia
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Ireland
Finland
Thailand
Korea, Republic of
France

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Ut Southwestern Medical Center At Dallas

location_facility: H. Lee Moffitt Cancer Center & Research Institute


title: NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014. Review.

ReferenceCitation: Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.

ReferenceCitation: Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.

location_country:
United Kingdom
Russian Federation
United States
France
South Africa
Germany

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

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.


acronym: ASPIRE

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

lead_sponsor: Tibotec Pharmaceuticals, Ireland

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

ReferenceCitation: Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.

ReferenceCitation: Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hezode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros PJ, Poordad F, Scott J, Lenz O, Peeters M, Sekar V, De Smedt G, Sinha R, Beumont-Mauviel M. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014 Feb;146(2):430-41.e6. doi: 10.1053/j.gastro.2013.10.058. Epub 2013 Nov 1.

location_country:
Poland
Portugal
United Kingdom
Austria
Australia
New Zealand
Canada
Russian Federation
United States
France
Israel
Belgium
Norway
Germany

summary: The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).


title: A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

summary:
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying.

GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.

ReferenceType: background

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Canada
United States
France


title: A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)

ReferenceCitation: Jackisch C, Stroyakovskiy D, Pivot X, Ahn JS, Melichar B, Chen SC, Meyenberg C, Al-Sakaff N, Heinzmann D, Hegg R. Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):e190339. doi: 10.1001/jamaoncol.2019.0339. Epub 2019 May 9.

ReferenceCitation: Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7. Epub 2012 Aug 9.

location_country:
Spain
Italy
Peru
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Argentina
Israel
Panama
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Guatemala
Hungary
Germany
Taiwan
Estonia
Thailand
Korea, Republic of
France
Colombia

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.

location_facility: Saratov Regional Clinical Hospital & Pathology Centre

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica

location_facility: Sankt Elisabeth Krankenhaus; Gynaekology

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

location_facility: Johanniter GmbH; Johanniter-Krankenhaus; Internistische Onkologie

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Wojewodzki Szpital Zespolony; Oddział Onkologii

location_facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Gachon Medical School Gil Medical Center; Medical Oncology

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Dokuz Eylul Uni Medical Faculty; Oncology Dept

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Hospital das Clinicas - UFPR; Quimioterapia

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

summary: In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.


acronym: EU/LA/AUS Pearl Index study – transdermal contraceptive patch

title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

location_country: Spain Italy Australia Argentina France Chile Mexico Germany

summary: The aim of the present study is to prove efficacy and safety of a new contraceptive patch.


title: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

summary: This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Australia
New Zealand
Canada
Thailand
Ukraine
Puerto Rico
United States
Costa Rica
France
Peru
Mexico
South Africa
Germany
Slovakia


title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)

summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.

ReferenceCitation: Mavroudi I, Pyrovolaki K, Pavlaki K, Kozana A, Psyllaki M, Kalpadakis C, Pontikoglou C, Papadaki HA. Effect of the nonpeptide thrombopoietin receptor agonist eltrombopag on megakaryopoiesis of patients with lower risk myelodysplastic syndrome. Leuk Res. 2011 Mar;35(3):323-8. doi: 10.1016/j.leukres.2010.06.029. Epub 2010 Aug 4.

ReferenceCitation: Platzbecker U, Wong RS, Verma A, Abboud C, Araujo S, Chiou TJ, Feigert J, Yeh SP, Götze K, Gorin NC, Greenberg P, Kambhampati S, Kim YJ, Lee JH, Lyons R, Ruggeri M, Santini V, Cheng G, Jang JH, Chen CY, Johnson B, Bennett J, Mannino F, Kamel YM, Stone N, Dougherty S, Chan G, Giagounidis A. Safety and tolerability of eltrombopag versus placebo for treatment of thrombocytopenia in patients with advanced myelodysplastic syndromes or acute myeloid leukaemia: a multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial. Lancet Haematol. 2015 Oct;2(10):e417-26. doi: 10.1016/S2352-3026(15)00149-0. Epub 2015 Oct 1.

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Taiwan
Brazil
Hong Kong
United Kingdom
Italy
Korea, Republic of
United States
France
Puerto Rico
Germany

intervention_type: Other


acronym: PILLAR

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects

ReferenceCitation: Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.

location_country:
Denmark
Poland
Spain
Austria
Australia
New Zealand
Canada
Russian Federation
United States
France
Belgium
Norway
Germany

summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.


ipd_sharing: Undecided

title: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0.

ReferenceCitation: Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing …. Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9. Review.

ReferenceCitation: Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
United Kingdom
Italy
Venezuela
United States
Peru
Belgium
Japan
South Africa
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
Turkey
Mexico
Egypt
Brazil
Lebanon
Canada
Switzerland
China
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France
Colombia

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (2)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Central Indiana Cancer Centers CICC - East (3)

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: Northwest Cancer Specialists Vancouver Cancer Center (3)

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: New York Oncology Hematology NYOH Amsterdam

location_facility: Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: University of California at Los Angeles Dept. of UCLA

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)

summary: The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.


title: An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

lead_sponsor: Onxeo

location_country:
Denmark
United States
Germany
France

location_facility: Tennessee Oncology Sarah Cannon Research

location_facility: CRLCC Francois Baclesse, Oncologie medicale

location_facility: Carl-Gustav-Carus Medicinische Klinik und Poliklinik I

location_facility: Chattanooga Oncology & Hematology Associates, PC

location_facility: Centre Henri Becquerel, Oncologie Médicale


title: Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

ReferenceCitation: Ghofrani HA, Grimminger F, Grünig E, Huang Y, Jansa P, Jing ZC, Kilpatrick D, Langleben D, Rosenkranz S, Menezes F, Fritsch A, Nikkho S, Humbert M. Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):361-71. doi: 10.1016/S2213-2600(16)30019-4. Epub 2016 Apr 8.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

ReferenceCitation: Rubin LJ, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh A, Langleben D, Fritsch A, Menezes F, Davie N, Ghofrani HA. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). Eur Respir J. 2015 May;45(5):1303-13. doi: 10.1183/09031936.00090614. Epub 2015 Jan 22.

ReferenceCitation: Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

location_country:
United Kingdom
Italy
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Thailand
Korea, Republic of
France

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

summary: Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.


title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: aHUS

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

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.

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nürnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

lead_sponsor: Alexion Pharmaceuticals

location_country:
United Kingdom
Austria
United States
France
Germany


title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma

summary: Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

ReferenceCitation: Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Poland
United Kingdom
Netherlands
United States
France
South Africa
Norway
Germany


title: An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

summary: A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.

ReferenceCitation: Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M; INTEREST IN CD group. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. 2012 Jun 14;2(3). pii: e000881. doi: 10.1136/bmjopen-2012-000881. Print 2012. Erratum in: BMJ Open. 2013 May 31;3(5):null.

lead_sponsor: Ipsen

location_country:
Portugal
United Kingdom
Russian Federation
Australia
Netherlands
France
Belgium
Germany
Czechia

location_facility: Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

location_facility: Hospital General San Antonio - Centro Hospitalar do Porto

location_facility: Walton Centre for Neurology & Neurosurgery, Hope Hospital

location_facility: Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen

location_facility: National Hospital for Neurology & Neurosurgery

location_facility: Praxis für Neurologie, International Neuroscience Institute

location_facility: Serviço de Neurologia - Hospital de São João


title: An Open-Label Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer

summary:
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer.

This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

ReferenceCitation: Kaufman PA, Wildiers H, Freyer G, Kemeny M, Gonçalves A, Jerusalem G, Stopeck A, Vrindavanam N, Dalenc F, Nanayakkara N, Wu B, Pickett CA. Phase 1b Study of Trebananib Plus Paclitaxel and Trastuzumab in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):47-57. doi: 10.1016/j.clbc.2018.09.012. Epub 2018 Oct 9.

lead_sponsor: Amgen

location_country:
United States
France
Belgium


title: An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia

summary: The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.

ReferenceCitation: Döhner H, Lübbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM, Lepretre S, Reman O, Turlure P, Ottmann OG, Müller-Tidow C, Krämer A, Raffoux E, Döhner K, Schlenk RF, Voss F, Taube T, Fritsch H, Maertens J. Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. Blood. 2014 Aug 28;124(9):1426-33. doi: 10.1182/blood-2014-03-560557. Epub 2014 Jul 8.

lead_sponsor: Boehringer Ingelheim

location_country: Italy Austria Canada France Belgium Norway Germany

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: HOP, Centre Hospitalier René Dubos, Hémato, Paris


title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

summary: This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

status: Terminated

lead_sponsor: Biogen

location_country:
Poland
United Kingdom
Austria
Australia
Canada
United States
France
Belgium

location_facility: Vanderbilt University Medical Center-IPF Program

location_facility: University of Miami Miller School of Medicine

location_facility: University of Florida/Pulmonary, Critical Care & Sleep Medicine

status_simplified: Unknown


title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Hollander P, Raslova K, Skjøth TV, Råstam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.

location_country:
Finland
Canada
Hungary
Korea, Republic of
United States
France
Turkey
Slovakia

summary: This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.


title: A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency

lead_sponsor: Novartis

location_country:
Spain
Russian Federation
Australia
Finland
Argentina
Canada
Sweden
Costa Rica
France
India
Norway
Germany

location_facility: MSU of Medicine and Dentistry on the base of CityHospital 23

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Saint-Petersburg State Pavlov's Medical University

location_facility: Forschungszentrum Ruhr, KliFoCenter GmbH

location_facility: M V Hospital for Diabetes and Diabetic Research Center

location_facility: Instituto de Investigaciones Clinicas de Mar del Plata

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Univ.-Klinikum München, Campus Innenstadt

location_facility: Tampereen lääkärikeskus Oy, Koskiklinikka

location_facility: MSUMD on the base of City Clinical Hospital #67

location_facility: Ciutat Sanitaria I Universitaria de Bellvitge

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: St. Olavs Hospital, Endokrinologisk seksjon

location_facility: Saint- Petersburg State Mtchnikov's Medical Academy

location_facility: Site Management Organisation of Clinical Trials Centers

location_facility: Health Sciences Centre - Diabetes Research Group

location_facility: City polyclinic # 17, City Diabetic Centre #3

location_facility: Hospital General de Jerez de La Frontera

location_facility: Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann


acronym: TOWER

title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

ReferenceCitation: Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

ReferenceCitation: Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.

ReferenceCitation: Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.

ReferenceCitation: Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

location_country:
Spain
United Kingdom
Ukraine
United States
Romania
Belgium
Philippines
Poland
Austria
Australia
Tunisia
Turkey
Mexico
Sweden
Slovakia
Canada
China
Germany
Belarus
Greece
Estonia
Czech Republic
Thailand
France
Chile
Netherlands

location_facility: Sanofi-Aventis Investigational Site Number 152006

location_facility: Sanofi-Aventis Investigational Site Number 040001

location_facility: Sanofi-Aventis Investigational Site Number 840076

location_facility: Sanofi-Aventis Investigational Site Number 788004

location_facility: Sanofi-Aventis Investigational Site Number 203001

location_facility: Sanofi-Aventis Investigational Site Number 826001

location_facility: Sanofi-Aventis Investigational Site Number 642005

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 804118

location_facility: Sanofi-Aventis Investigational Site Number 840064

location_facility: Sanofi-Aventis Investigational Site Number 203004

location_facility: Sanofi-Aventis Investigational Site Number 804124

location_facility: Sanofi-Aventis Investigational Site Number 156017

location_facility: Sanofi-Aventis Investigational Site Number 792012

location_facility: Sanofi-Aventis Investigational Site Number 840071

location_facility: Sanofi-Aventis Investigational Site Number 156031

location_facility: Sanofi-Aventis Investigational Site Number 156014

location_facility: Sanofi-Aventis Investigational Site Number 804117

location_facility: Sanofi-Aventis Investigational Site Number 788002

location_facility: Sanofi-Aventis Investigational Site Number 840075

location_facility: Sanofi-Aventis Investigational Site Number 764001

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 804102

location_facility: Sanofi-Aventis Investigational Site Number 804103

location_facility: Sanofi-Aventis Investigational Site Number 840066

location_facility: Sanofi-Aventis Investigational Site Number 156003

location_facility: Sanofi-Aventis Investigational Site Number 840069

location_facility: Sanofi-Aventis Investigational Site Number 124004

location_facility: Sanofi-Aventis Investigational Site Number 156018

location_facility: Sanofi-Aventis Investigational Site Number 036005

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 792010

location_facility: Sanofi-Aventis Investigational Site Number 804119

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 156034

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 764002

location_facility: Sanofi-Aventis Investigational Site Number 156022

location_facility: Sanofi-Aventis Investigational Site Number 840073

location_facility: Sanofi-Aventis Investigational Site Number 804116

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 804121

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 156032

location_facility: Sanofi-Aventis Investigational Site Number 804101

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 300001

location_facility: Sanofi-Aventis Investigational Site Number 840079

location_facility: Sanofi-Aventis Investigational Site Number 156012

location_facility: Sanofi-Aventis Investigational Site Number 156016

location_facility: Sanofi-Aventis Investigational Site Number 804122

location_facility: Sanofi-Aventis Investigational Site Number 840060

location_facility: Sanofi-Aventis Investigational Site Number 840083

location_facility: Sanofi-Aventis Investigational Site Number 156033

location_facility: Sanofi-Aventis Investigational Site Number 156001

location_facility: Sanofi-Aventis Investigational Site Number 036008

location_facility: Sanofi-Aventis Investigational Site Number 804109

location_facility: Sanofi-Aventis Investigational Site Number 276010

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 788001

location_facility: Sanofi-Aventis Investigational Site Number 840022

location_facility: Sanofi-Aventis Investigational Site Number 152007

location_facility: Sanofi-Aventis Investigational Site Number 124002

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 112105

location_facility: Sanofi-Aventis Investigational Site Number 804111

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 840016

location_facility: Sanofi-Aventis Investigational Site Number 608003

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 156008

location_facility: Sanofi-Aventis Investigational Site Number 156023

location_facility: Sanofi-Aventis Investigational Site Number 792005

location_facility: Sanofi-Aventis Investigational Site Number 826003

location_facility: Sanofi-Aventis Investigational Site Number 804107

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 156030

location_facility: Sanofi-Aventis Investigational Site Number 840090

location_facility: Sanofi-Aventis Investigational Site Number 840068

location_facility: Sanofi-Aventis Investigational Site Number 156035

location_facility: Sanofi-Aventis Investigational Site Number 840063

location_facility: Sanofi-Aventis Investigational Site Number 112103

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 804108

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 840078

location_facility: Sanofi-Aventis Investigational Site Number 804115

location_facility: Sanofi-Aventis Investigational Site Number 840074

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 276003

location_facility: Sanofi-Aventis Investigational Site Number 608001

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 703005

location_facility: Sanofi-Aventis Investigational Site Number 840025

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 840084

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 156005

location_facility: Sanofi-Aventis Investigational Site Number 804114

location_facility: Sanofi-Aventis Investigational Site Number 156021

location_facility: Sanofi-Aventis Investigational Site Number 112102

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 792007

location_facility: Sanofi-Aventis Investigational Site Number 156010

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 642006

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 156019

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 036006

location_facility: Sanofi-Aventis Investigational Site Number 703001

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 804105

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 484005

location_facility: Sanofi-Aventis Investigational Site Number 840088

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 642001

location_facility: Sanofi-Aventis Investigational Site Number 703003

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 156025

location_facility: Sanofi-Aventis Investigational Site Number 840007

location_facility: Sanofi-Aventis Investigational Site Number 156004

location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 528006

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 112104

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 156002

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 276007

location_facility: Sanofi-Aventis Investigational Site Number 300006

location_facility: Sanofi-Aventis Investigational Site Number 156024

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 792009

location_facility: Sanofi-Aventis Investigational Site Number 608002

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 788003

location_facility: Sanofi-Aventis Investigational Site Number 840086

location_facility: Sanofi-Aventis Investigational Site Number 642007

location_facility: Sanofi-Aventis Investigational Site Number 840034

location_facility: Sanofi-Aventis Investigational Site Number 112101

location_facility: Sanofi-Aventis Investigational Site Number 276009

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 156015

location_facility: Sanofi-Aventis Investigational Site Number 156029

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 840089

location_facility: Sanofi-Aventis Investigational Site Number 703006

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 804120

location_facility: Sanofi-Aventis Investigational Site Number 156009

location_facility: Sanofi-Aventis Investigational Site Number 826004

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 156011

location_facility: Sanofi-Aventis Investigational Site Number 616003

location_facility: Sanofi-Aventis Investigational Site Number 156028

location_facility: Sanofi-Aventis Investigational Site Number 792011

location_facility: Sanofi-Aventis Investigational Site Number 156006

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 124008

location_facility: Sanofi-Aventis Investigational Site Number 608004

location_facility: Sanofi-Aventis Investigational Site Number 156027

location_facility: Sanofi-Aventis Investigational Site Number 156007

location_facility: Sanofi-Aventis Investigational Site Number 804104

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 792002

summary:
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

To assess the effect of the two doses of teriflunomide in comparison to placebo on:

Fatigue;
Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
To evaluate the safety and tolerability of teriflunomide.


acronym: READY

title: A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

ReferenceCitation: Araujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, Wilding G, McCaffrey J, Serrano SV, Matveev VB, Efstathiou E, Oudard S, Morris MJ, Sizer B, Goebell PJ, Heidenreich A, de Bono JS, Begbie S, Hong JH, Richardet E, Gallardo E, Paliwal P, Durham S, Cheng S, Logothetis CJ. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1307-16. doi: 10.1016/S1470-2045(13)70479-0. Epub 2013 Nov 8.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
South Africa
Poland
Russian Federation
Australia
Argentina
India
Mexico
Norway
Sweden
Brazil
Canada
Hungary
Germany
Greece
Ireland
Finland
Czech Republic
Korea, Republic of
France

location_facility: Compassionate Cancer Care Medical Group Inc

location_facility: University Of South Alabama / Mitchell Cancer Institute

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: Fort Wayne Medical Oncology And Hematology Inc

location_facility: Piedmont Hematology Oncology Associates, Pllc

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Desert Hematology Oncology Medical Group

location_facility: North Mississippi Hematology And Oncology Associates, Ltd

summary: The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.


acronym: ADVANTAGE

title: Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

lead_sponsor: Merck KGaA, Darmstadt, Germany

ReferenceCitation: Vermorken JB, Peyrade F, Krauss J, Mesía R, Remenar E, Gauler TC, Keilholz U, Delord JP, Schafhausen P, Erfán J, Brümmendorf TH, Iglesias L, Bethe U, Hicking C, Clement PM. Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). Ann Oncol. 2014 Mar;25(3):682-688. doi: 10.1093/annonc/mdu003.

location_country: Poland Spain Italy Austria Switzerland Hungary France Belgium Germany

summary:
The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).

The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial, cilengitide is administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.

Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially inhibits the ingrowth of additional blood vessels towards the tumor.

Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.