title: Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Nauck MA, Petrie JR, Sesti G, Mannucci E, Courrèges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

location_country:
Spain
Italy
Austria
United Kingdom
Finland
Switzerland
Former Serbia and Montenegro
Hungary
France
India
Turkey
South Africa
Germany
Bulgaria

summary: This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.


title: An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

summary: An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Spain
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

summary:
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

design_allocation: Randomized

lead_sponsor: AEterna Zentaris

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Leicester General Hospital, Urology Section

location_facility: Policlinic Pod Marjánkou 12, Urological Department

location_facility: National Central Hospital for Active Treatment of Oncology JSC

location_facility: Urologische Praxisgemeinschaft Frankfurt Höchst

location_facility: Urologische Klinik, Ev. Krankenhaus Oberhausen

location_facility: Bristol Royal Infirmary, Urology Research Unit

location_facility: University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department

location_facility: Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

location_facility: Klinikum Offenbach GmbH, Klinik für Urologie

location_facility: University of Bari, Department of Urology

location_facility: 19th Central Regional Policlinic, Urology department

location_facility: Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"

location_facility: 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology

location_facility: Minsk Regional Clinical Hospital, Clinic of Urology

location_facility: Multiprofil Hospital "Sveta Anna", Urology Department

location_facility: Urocentrum Prague, Out-Patient Clinic of Urology

location_facility: Aleksandrovska Hospital, Kidney Transplantation Department

location_facility: Clinica Chirurgie Urologica si Transplant Renal

location_facility: Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie

location_facility: Aleksandrovska Hospital, Oncourology Department

location_facility: Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele

location_facility: University of Padova, Department of Urology

intervention_type: Other


title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

summary: The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

ReferenceType: derived

ReferenceCitation: Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjöström CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15.

ReferenceCitation: Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.

lead_sponsor: AstraZeneca

location_country:
Denmark
Spain
Italy
Australia
Argentina
Canada
Puerto Rico
United States
France
India
Peru
Mexico
Singapore

location_facility: Zablocki Veterans Affairs Medical Center

location_facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)

location_facility: University Of Medicine And Dentistry Of New Jersey

location_facility: Center For Thyroid Diseases And Endocrinology


acronym: Not applicable

title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

lead_sponsor: Eisai Inc.

type: EudraCT Number

source: euctr

ReferenceCitation: Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.

location_country:
Croatia
Latvia
Australia
Estonia
Argentina
Canada
Hungary
United States
Chile
France
India
Germany
Bulgaria

summary: The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).


title: A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.

summary: This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Romania
Belgium
Poland
Hong Kong
Austria
Australia
Argentina
Israel
Mexico
Singapore
Brazil
Canada
Germany
Denmark
Taiwan
Greece
France


title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

summary: The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

lead_sponsor: Janssen-Cilag International NV

location_country:
Jordan
Spain
Greece
Latvia
Estonia
Lebanon
Argentina
Lithuania
France
South Africa
Turkey
Romania
Slovakia
Egypt


ipd_sharing: Yes

status: Terminated

title: A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

study_start_date_type: Actual

ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

ReferenceCitation: Pappo AS, Patel SR, Crowley J, Reinke DK, Kuenkele KP, Chawla SP, Toner GC, Maki RG, Meyers PA, Chugh R, Ganjoo KN, Schuetze SM, Juergens H, Leahy MG, Geoerger B, Benjamin RS, Helman LJ, Baker LH. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011 Dec 1;29(34):4541-7. doi: 10.1200/JCO.2010.34.0000. Epub 2011 Oct 24.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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

location_facility: Massachusetts General Hospital; Dana Farber Partnes Cancer Center

location_facility: Nebraska Methodist Hospital; Onc Hem West

location_facility: Oregon Health and Science University Cancer Institute

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III

location_facility: Huntsman Cancer Institute; Orthopedic Center

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Texas Children's Cancer Center; Baylor College of Medicine

location_facility: Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie

location_facility: Albert Einstein College of Medical Pediatrics; Department of Pediatrics

location_facility: Washington Cancer Institute; Washington Hospital Center

summary: The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.

status_simplified: Unknown


title: Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

summary: The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

ReferenceType: result

ReferenceCitation: Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.

ReferenceCitation: Guja C, Frías JP, Suchower L, Hardy E, Marr G, Sjöström CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum in: Diabetes Ther. 2020 Dec;11(12):3011-3013.

ReferenceCitation: Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4. Erratum in: Lancet Diabetes Endocrinol. 2014 Jun;2(6):e13.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

ReferenceCitation: Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.

ReferenceCitation: Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

ReferenceCitation: Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.

location_country:
Denmark
Taiwan
Spain
Greece
Russian Federation
Australia
Mexico
Netherlands
Czech Republic
Hungary
Korea, Republic of
United States
France
Puerto Rico
Belgium
Germany


title: A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine

acronym: SETTLE

summary:
Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man.

Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.

The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.

ReferenceCitation: Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467.

lead_sponsor: Newron Pharmaceuticals SPA

location_country:
Spain
United Kingdom
United States
Belgium
Austria
Australia
India
Israel
Malaysia
Slovakia
Canada
Switzerland
Hungary
Germany
Taiwan
Estonia
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: Nestatne zdravotnicke zariadenie Neurologicka ambulancia

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Parkinson's Disease and Movement Disorder Center

location_facility: Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály

location_facility: MU Dr.Beata Dupejová neurologicka ambulancia s.r.o

location_facility: Northwestern University PD and Movement Disorders Center

location_facility: University Health Network -Toronto Western Hosp.

location_facility: Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.

location_facility: Vseobecna nemocnica s poliklinikou Levoca

location_facility: Institute for Neurodegenerative Disorders

location_facility: Fakultna nemocnica Trnava Interna klinika

location_facility: Parkinson's Disease Treatment Center of SW Florida

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Van der Veer Institute for Parkinson's & Brain Research

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Clinexpert Kereskedelmi es Szolgaltato Kft.

location_facility: Charité Campus Virchow Universitaetsmedizin Berlin

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: University Of South Florida Medical Center

location_facility: CHU Nantes Hôpital Laennec - CIC Neurologie

location_facility: Sopron Medical Egeszsegugyi Szolgaltato Kft.

location_facility: BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke


title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

acronym: CAP

summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

ReferenceCitation: Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.

ReferenceCitation: Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

ReferenceCitation: Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24. Review. Erratum in: J Antimicrob Chemother. 2016 Jun;71(6):1748-9.

ReferenceCitation: Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.

ReferenceCitation: Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.

ReferenceCitation: File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii19-32. doi: 10.1093/jac/dkr096.

ReferenceCitation: Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.

lead_sponsor: Forest Laboratories

location_country:
Serbia
Spain
Lithuania
Ukraine
United States
Romania
South Africa
Poland
Austria
Russian Federation
Argentina
India
Malaysia
Slovakia
Brazil
Switzerland
Hungary
Germany
Bulgaria
Georgia
Estonia
Thailand
France

location_facility:
Investigational Site 1
Inestigational Site
Investigational Site
Investigational site
Investigational Site 2
InvestigationalSite
Slovakia


title: A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma

summary: The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Italy
Canada
United States
France
Germany

location_facility: Indiana University Melvin And Bren Simon Cancer Center

location_facility: Blumenthal Cancer Center, Carolinas Medical Center

location_facility: Harry & Jeanette Weinberg Cancer Inst At Franklin Square


type: Other Identifier

type: Registry Identifier

title: Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo

summary:
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. The build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some participants. In this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.

Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study (H6L-MC-LFBC [LFBC; NCT00762411]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol.

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

ReferenceCitation: Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of γ-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015.

ReferenceCitation: Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee, Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Finland
Sweden
United States
Chile
France
India
Belgium
Israel
Germany
South Africa
Japan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects With Ventilator-Associated Pneumonia

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

ReferenceCitation: Kollef MH, Chastre J, Clavel M, Restrepo MI, Michiels B, Kaniga K, Cirillo I, Kimko H, Redman R. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012 Nov 13;16(6):R218. doi: 10.1186/cc11862.

location_country:
Spain
Ukraine
United States
Romania
Belgium
Philippines
Portugal
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Brazil
Canada
Guatemala
Hungary
Germany
Thailand
France

summary: The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia.


title: Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

summary: The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

ReferenceCitation: Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Gonçalves A, Campone M, Lardelli P, Kahatt C, Nieto A, Cullell-Young M, Lubinski J. Activity of trabectedin in germline BRCA1/2-mutated metastatic breast cancer: results of an international first-in-class phase II study. Ann Oncol. 2014 Jun;25(6):1152-8. doi: 10.1093/annonc/mdu134. Epub 2014 Apr 1.

location_country:
Poland
United States
Israel
France


intervention_type: Biological

title: A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

lead_sponsor: Ipsen

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany
Czechia

location_facility: CH Régional Huy - Polyclinique A Rue Trois Ponts

location_facility: Erasmus MC, Universitair Medisch Centrum Rotterdam

location_facility: Unità Spinale, Azienda Ospedaliera Careggi

location_facility: Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon

location_facility: General Urology Academisch Ziekenhuis Maastricht

summary: The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

acronym: VELOUR

summary:
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

ReferenceCitation: Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6.

ReferenceCitation: Chau I, Fakih M, García-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3). pii: E657. doi: 10.3390/cancers12030657.

ReferenceCitation: Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12.

ReferenceCitation: Stanel SC, Sjöberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017. Review.

ReferenceCitation: Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomý R, Prausová J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kröning H, Humblet Y, Grávalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9.

ReferenceCitation: Tabernero J, Van Cutsem E, Lakomý R, Prausová J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

ReferenceCitation: Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausová J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. Epub 2012 Sep 4.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Turkey
Norway
Sweden
Brazil
Germany
Denmark
Greece
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility: Sanofi-Aventis Investigational Site Number 040001

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 840206

location_facility: Sanofi-Aventis Investigational Site Number 840094

location_facility: Sanofi-Aventis Investigational Site Number 840076

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 203001

location_facility: Sanofi-Aventis Investigational Site Number 826001

location_facility: Sanofi-Aventis Investigational Site Number 826008

location_facility: Sanofi-Aventis Investigational Site Number 642005

location_facility: Sanofi-Aventis Investigational Site Number 840085

location_facility: Sanofi-Aventis Investigational Site Number 056007

location_facility: Sanofi-Aventis Investigational Site Number 300005

location_facility: Sanofi-Aventis Investigational Site Number 804004

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 578003

location_facility: Sanofi-Aventis Investigational Site Number 840606

location_facility: Sanofi-Aventis Investigational Site Number 840087

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 203004

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 840701

location_facility: Sanofi-Aventis Investigational Site Number 840071

location_facility: Sanofi-Aventis Investigational Site Number 840406

location_facility: Sanofi-Aventis Investigational Site Number 840053

location_facility: Sanofi-Aventis Investigational Site Number 076007

location_facility: Sanofi-Aventis Investigational Site Number 840075

location_facility: Sanofi-Aventis Investigational Site Number 840049

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 380006

location_facility: Sanofi-Aventis Investigational Site Number 840082

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 840097

location_facility: Sanofi-Aventis Investigational Site Number 578002

location_facility: Sanofi-Aventis Investigational Site Number 642003

location_facility: Sanofi-Aventis Investigational Site Number 840095

location_facility: Sanofi-Aventis Investigational Site Number 840098

location_facility: Sanofi-Aventis Investigational Site Number 036005

location_facility: Sanofi-Aventis Investigational Site Number 840044

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 840031

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 840706

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 300004

location_facility: Sanofi-Aventis Investigational Site Number 840106

location_facility: Sanofi-Aventis Investigational Site Number 840073

location_facility: Sanofi-Aventis Investigational Site Number 840043

location_facility: Sanofi-Aventis Investigational Site Number 840099

location_facility: Sanofi-Aventis Investigational Site Number 032003

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 554009

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840042

location_facility: Sanofi-Aventis Investigational Site Number 804002

location_facility: Sanofi-Aventis Investigational Site Number 826009

location_facility: Sanofi-Aventis Investigational Site Number 840047

location_facility: Sanofi-Aventis Investigational Site Number 840118

location_facility: Sanofi-Aventis Investigational Site Number 300001

location_facility: Sanofi-Aventis Investigational Site Number 710008

location_facility: Sanofi-Aventis Investigational Site Number 840079

location_facility: Sanofi-Aventis Investigational Site Number 076004

location_facility: Sanofi-Aventis Investigational Site Number 076005

location_facility: Sanofi-Aventis Investigational Site Number 804006

location_facility: Sanofi-Aventis Investigational Site Number 380007

location_facility: Sanofi-Aventis Investigational Site Number 826011

location_facility: Sanofi-Aventis Investigational Site Number 840306

location_facility: Sanofi-Aventis Investigational Site Number 840501

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 840122

location_facility: Sanofi-Aventis Investigational Site Number 840117

location_facility: Sanofi-Aventis Investigational Site Number 642002

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 554010

location_facility: Sanofi-Aventis Investigational Site Number 410005

location_facility: Sanofi-Aventis Investigational Site Number 840801

location_facility: Sanofi-Aventis Investigational Site Number 840070

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 152005

location_facility: Sanofi-Aventis Investigational Site Number 840506

location_facility: Sanofi-Aventis Investigational Site Number 840901

location_facility: Sanofi-Aventis Investigational Site Number 300002

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 152004

location_facility: Sanofi-Aventis Investigational Site Number 032005

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 630001

location_facility: Sanofi-Aventis Investigational Site Number 792005

location_facility: Sanofi-Aventis Investigational Site Number 826003

location_facility: Sanofi-Aventis Investigational Site Number 056005

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 840078

location_facility: Sanofi-Aventis Investigational Site Number 840115

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 528004

location_facility: Sanofi-Aventis Investigational Site Number 208001

location_facility: Sanofi-Aventis Investigational Site Number 840906

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 840806

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 840084

location_facility: Sanofi-Aventis Investigational Site Number 804005

location_facility: Sanofi-Aventis Investigational Site Number 076001

location_facility: Sanofi-Aventis Investigational Site Number 616006

location_facility: Sanofi-Aventis Investigational Site Number 840112

location_facility: Sanofi-Aventis Investigational Site Number 840014

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 840096

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 840004

location_facility: Sanofi-Aventis Investigational Site Number 642006

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 840101

location_facility: Sanofi-Aventis Investigational Site Number 840019

location_facility: Sanofi-Aventis Investigational Site Number 642004

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 840116

location_facility: Sanofi-Aventis Investigational Site Number 410002

location_facility: Sanofi-Aventis Investigational Site Number 840201

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 076006

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 036006

location_facility: Sanofi-Aventis Investigational Site Number 840046

location_facility: Sanofi-Aventis Investigational Site Number 724005

location_facility: Sanofi-Aventis Investigational Site Number 840021

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 724006

location_facility: Sanofi-Aventis Investigational Site Number 710007

location_facility: Sanofi-Aventis Investigational Site Number 380008

location_facility: Sanofi-Aventis Investigational Site Number 410003

location_facility: Sanofi-Aventis Investigational Site Number 840088

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 616007

location_facility: Sanofi-Aventis Investigational Site Number 840052

location_facility: Sanofi-Aventis Investigational Site Number 642001

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 840113

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 300003

location_facility: Sanofi-Aventis Investigational Site Number 840080

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 578001

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 840120

location_facility: Sanofi-Aventis Investigational Site Number 840072

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 710004

location_facility: Sanofi-Aventis Investigational Site Number 208003

location_facility: Sanofi-Aventis Investigational Site Number 826007

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 032007

location_facility: Sanofi-Aventis Investigational Site Number 840119

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 152003

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 410001

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 036007

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 840035

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 840401

location_facility: Sanofi-Aventis Investigational Site Number 840081

location_facility: Sanofi-Aventis Investigational Site Number 840114

location_facility: Sanofi-Aventis Investigational Site Number 076002

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 410004

location_facility: Sanofi-Aventis Investigational Site Number 840093

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 840089

location_facility: Sanofi-Aventis Investigational Site Number 840037

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 076003

location_facility: Sanofi-Aventis Investigational Site Number 840601

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 826010

location_facility: Sanofi-Aventis Investigational Site Number 826004

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 840048

location_facility: Sanofi-Aventis Investigational Site Number 076008

location_facility: Sanofi-Aventis Investigational Site Number 616003

location_facility: Sanofi-Aventis Investigational Site Number 032006

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 840301

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 792002


title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping.

summary:
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:

Death (all causes).
New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy.

An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

ReferenceCitation: Mayer SA, Aldrich EF, Bruder N, Hmissi A, Macdonald RL, Viarasilpa T, Marr A, Roux S, Higashida RT. Thick and Diffuse Subarachnoid Blood as a Treatment Effect Modifier of Clazosentan After Subarachnoid Hemorrhage. Stroke. 2019 Oct;50(10):2738-2744. doi: 10.1161/STROKEAHA.119.025682. Epub 2019 Aug 9.

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Marr A, Roux S, Kassell N. Randomised trial of clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid hemorrhage undergoing surgical clipping (CONSCIOUS-2). Acta Neurochir Suppl. 2013;115:27-31. doi: 10.1007/978-3-7091-1192-5_7.

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Marr A, Roux S, Kassell N. Clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping: a randomised, double-blind, placebo-controlled phase 3 trial (CONSCIOUS-2). Lancet Neurol. 2011 Jul;10(7):618-25. doi: 10.1016/S1474-4422(11)70108-9. Epub 2011 Jun 2.

ipd_sharing: No

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Croatia
Serbia
Spain
Italy
Ukraine
United States
Belgium
Czechia
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
India
Turkey
Norway
Singapore
Sweden
Canada
Switzerland
China
Germany
Denmark
Latvia
New Zealand
Finland
Korea, Republic of
France

location_facility: AKH University of Vienna, Medical University

location_facility: Oregon Health & Science University-Oregon Stroke Center

location_facility: Landeskrankenhaus und Medizinische Universitat Graz

location_facility: Katedra I Klinika Neurochirurgii i Dzieciecej

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Neurochirurggische Universitatsklinik des Heidelberg

location_facility: Katedra IKlinika Neurochirurgii Akademii Medycznej w Warszawie Clinic

location_facility: Toronto Western Hospital, University of Toronto

location_facility: Katedra Klinika Neurochirurgii Akademii Medycznej w Gdansku

location_facility: Samodzielny Publiczny Szpital Kliniczny Slaskiej Akademii Medycznej w Katowicach

location_facility: Azienda Ospedaliero-Universitaria di Careggi

location_facility: All India Insititute of Medicla Sciences (AIIMS)

location_facility: Thechnical University-Klinikum rechts der Isar

location_facility: University of Calgary Foothills Medical Center

location_facility: A. P. Romodanov Institute of Neurosurgery

location_facility: University of Cincinnati-Department of Neurosurgery

location_facility: Universitätsklinik Bern Klinik für Neurochirurgie

location_facility: Pole d'Anesthesie Reanimation, CHU D'Angers

location_facility: University of Virginia Health System-Department of Neurosurgery

location_facility: Sozialmedizinisches Zentrum Ost (ZMZ-Ost) Donauspital Vienna

location_facility: Virginia Commonwealth University-Department of Neurosurgery

location_facility: XuanWu Hospital Institute of Brain Vascular Disease

location_facility: University Hospitals Case Medical Center-Department of Neurosurgery

location_facility: Kathedra I Klinika Neurochirurghii I Neurotraumatologii Collegium Medicum im. L. Rydygiera w Bydgoszc

location_facility: Scientific Research Institute of Neurosurgery by Burdenko

location_facility: University Fur Neurochirurgie, SALK, Christian Doppler Hospital

location_facility: State University of New York at Stony Brook-Health Sciences Center

location_facility: Riga Eastern Clinical University Hospital

location_facility: Thomas Jefferson University School of Medicine-Jefferson Hospital for Neuroscience

location_facility: Oddzial Kliniczny Kliniki Neurochirurgii i Neurotrumatologii Szpitala, Uniwersyteckiego w Krakowie

location_facility: Uppsala University Hospital-Uppsala Akademiska Sjukhus

location_facility: Ibn-i Sina Hastanesi Ankara & Ankara Universitesi Tip Fakultesi

location_facility: Haukeland University Hospital Helse Bergen HF

location_facility: Hopital Neurologique et Neuro-Chirurgical Pierre Wertheimer

location_facility: Charite Universitatsmedizin Berlin-Neurochirurgische Klinik-CVK

location_facility: Universitatsklinik Frankfurt, Klinik und Poliklinik fur Neurochirurgie

location_facility: Klinika Neurochirurgii AMB-Neurosurgery Clinic of Medical Academy

location_facility: Cliniques Universitaires Saint-Luc, Universite Catholique de

location_facility: Guangdong Province Chinese Medicine Hospital


title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

lead_sponsor: ACADIA Pharmaceuticals Inc.

ReferenceCitation: Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119. Review.

ReferenceCitation: Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.

location_country:
Poland
Portugal
Serbia
United Kingdom
Italy
Austria
Russian Federation
Canada
Ukraine
United States
France
India
Belgium
Sweden

summary: To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.


title: Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

ReferenceCitation: Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.

location_country:
Denmark
Spain
United Kingdom
Russian Federation
Finland
Former Serbia and Montenegro
Sweden
United States
France
South Africa
Norway
Netherlands

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

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.


title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).

location_country:
Portugal
Italy
Korea, Republic of
United States
France
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies)

summary: PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.

study_type: Observational

time_perspective: Prospective

lead_sponsor: St. Justine's Hospital

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

location_facility: General University Hospital Gregorio Marañón

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Hospital Sant Joan de Déu-Hospital Clinic

location_facility: Hospital Universitario Central de Asturias

lead_sponsor_type: academique


title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

ReferenceCitation: Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.

ReferenceCitation: Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.

ReferenceCitation: Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

ReferenceCitation: Valentine WJ, Palmer AJ, Lammert M, Langer J, Brändle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

ReferenceCitation: Davidson JA, Ørsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

location_country: Macedonia, The Former Yugoslav Republic of

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


title: An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

summary: The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

ReferenceCitation: Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.

ReferenceCitation: Rosenow F, Kelemen A, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP774 study investigators. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.

lead_sponsor: UCB Pharma

location_country:
Croatia
Poland
Spain
United Kingdom
Russian Federation
Australia
Finland
Lithuania
Sweden
Hungary
France
Germany
Czechia


title: A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Italy
Canada
Puerto Rico
United States
France
Mexico
Germany

location_facility:
Site Reference ID/Investigator# 8481
Site Reference ID/Investigator# 5836
Site Reference ID/Investigator# 7064
Site Reference ID/Investigator# 7115
Site Reference ID/Investigator# 5018
Site Reference ID/Investigator# 5216
Site Reference ID/Investigator# 5947
Site Reference ID/Investigator# 6045
Site Reference ID/Investigator# 6044
Site Reference ID/Investigator# 6732
Site Reference ID/Investigator# 8120
Site Reference ID/Investigator# 6763
Site Reference ID/Investigator# 6869
Site Reference ID/Investigator# 6054
Site Reference ID/Investigator# 5217
Site Reference ID/Investigator# 5171
Site Reference ID/Investigator# 8113
Site Reference ID/Investigator# 7699
Site Reference ID/Investigator# 8427
Site Reference ID/Investigator# 5034
Site Reference ID/Investigator# 6781
Site Reference ID/Investigator# 6053
Site Reference ID/Investigator# 8436
Site Reference ID/Investigator# 5206
Site Reference ID/Investigator# 7483
Site Reference ID/Investigator# 5260
Site Reference ID/Investigator# 5006
Site Reference ID/Investigator# 5950
Site Reference ID/Investigator# 6760
Site Reference ID/Investigator# 5207
Site Reference ID/Investigator# 5258
Site Reference ID/Investigator# 6043
Site Reference ID/Investigator# 6052
Site Reference ID/Investigator# 7696
Site Reference ID/Investigator# 5277
Site Reference ID/Investigator# 8125
Site Reference ID/Investigator# 5899
Site Reference ID/Investigator# 8121
Site Reference ID/Investigator# 8286
Site Reference ID/Investigator# 7187
Site Reference ID/Investigator# 7906
Site Reference ID/Investigator# 7117
Site Reference ID/Investigator# 5276
Site Reference ID/Investigator# 6047
Site Reference ID/Investigator# 7514
Site Reference ID/Investigator# 8497
Site Reference ID/Investigator# 7387
Site Reference ID/Investigator# 8508
Site Reference ID/Investigator# 5946

summary: This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.


title: A Randomized, Double-blind, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile Function

summary: A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

lead_sponsor: Bayer

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Canada
Switzerland
Sweden
United States
France
South Africa
Belgium
Norway
Germany


title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.

ReferenceCitation: Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.

ReferenceCitation: Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Järnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.

location_country:
Serbia
Lithuania
Ukraine
United States
Romania
Belgium
Japan
South Africa
Poland
Austria
Australia
Russian Federation
India
Israel
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Denmark
New Zealand
Czech Republic
France
Netherlands

summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).


title: Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.

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

summary: The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis


title: A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).

summary: This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

enrollment_type: Anticipated

lead_sponsor: Pfizer

location_country:
Poland
Spain
Greece
Italy
Australia
Latvia
Finland
Canada
Switzerland
United Kingdom
France
Chile
Colombia
Norway
Germany
Slovakia


title: A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

summary: This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x. Erratum in: Diabet Med. 2010 Jun;27(6):732.

lead_sponsor: Hoffmann-La Roche

location_country:
Australia
Puerto Rico
United States
France
Peru
Mexico
Germany


title: A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane

summary: The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

ReferenceCitation: Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3.

location_country:
Australia
Argentina
France
South Africa
Mexico


title: Study EGF107671 - a Phase II Study of Lapatinib Plus Topotecan or Lapatinib Plus Capecitabine in the Treatment of Recurrent Brain Metastases From ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

summary: This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

ReferenceCitation: Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. J Neurooncol. 2011 Dec;105(3):613-20. doi: 10.1007/s11060-011-0629-y. Epub 2011 Jun 26.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Greece
Austria
Italy
Canada
Sweden
United States
France
Israel
Belgium
Germany


title: A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC

acronym: ZEAL

summary: Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: de Boer RH, Arrieta Ó, Yang CH, Gottfried M, Chan V, Raats J, de Marinis F, Abratt RP, Wolf J, Blackhall FH, Langmuir P, Milenkova T, Read J, Vansteenkiste JF. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2011 Mar 10;29(8):1067-74. doi: 10.1200/JCO.2010.29.5717. Epub 2011 Jan 31.

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
United Kingdom
Venezuela
United States
Belgium
Philippines
South Africa
Hong Kong
Portugal
Australia
Argentina
India
Israel
Mexico
Sweden
Germany
Taiwan
Greece
France
Colombia

status_simplified: Ongoing


title: A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

summary: The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

ReferenceCitation: Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.

ReferenceCitation: Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Spain
Italy
United States
Belgium
Poland
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Malaysia
Egypt
Brazil
Canada
Switzerland
Hungary
China
Germany
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi

location_facility: University of California at San Francisco

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Upstate Infectious Diseases Association LLP

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: The First Affiliated Hospital, Med. School, Zhejiang Uni.

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: The Catholic University of Korea, St. Mary's Hospital

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: The Affiliated Union Hospital of Fujian Medical University

location_facility: Charité Universitaetsmedizin Berlin- Campus Charité Mitte

location_facility: Huashan Hospital, Insitute of Antibiotics

location_facility: Tata Memorial Hopital, Department of Anesthesia

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: Republican Hospital named after V.A. Baranov

location_facility: West China Hospital of Sichuan University

location_facility: The 1st Affiliated Hospital of Guangxi Medical University


primary_purpose: Prevention

title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

ReferenceCitation: Ison MG, Szakaly P, Shapira MY, Kriván G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.

location_country:
Poland
Spain
Italy
United Kingdom
Estonia
Canada
Czech Republic
Lithuania
Hungary
United States
France
Israel
Belgium
Germany

summary: This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

ReferenceCitation: Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

ReferenceCitation: Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

ReferenceCitation: Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.

ReferenceCitation: Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1). pii: e000459. doi: 10.1136/lupus-2020-000459.

ReferenceCitation: Gomez A, Hani Butrus F, Johansson P, Åkerström E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.

ReferenceCitation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

ReferenceCitation: Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

ReferenceCitation: Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.

ReferenceCitation: Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.

ReferenceCitation: Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.

ReferenceCitation: Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.

ReferenceCitation: Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzová D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; BLISS-76 Study Group. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 Aug;39(8):1632-40. Epub 2012 Jun 15.

ReferenceCitation: van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.

ReferenceCitation: Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.

ReferenceCitation: Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. doi: 10.1002/art.30613.

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.

lead_sponsor: Human Genome Sciences Inc.

location_country:
Poland
Romania
Spain
Italy
Austria
Mexico
Netherlands
Canada
Czech Republic
United Kingdom
Sweden
Puerto Rico
United States
Costa Rica
France
Israel
Belgium
Germany
Slovakia

location_facility: University of North Carolina at Chapel Hill

location_facility: U.O. di reumatologia Presidio Ospedaliero di Scafati

location_facility: Washington University School of Medicine

location_facility: Arthritis Clinic of Northern Virginia, P.C.

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Arthritis Associates of Colorado Springs

location_facility: Arizona Arthritis and Rheumatology Research, PPLC

location_facility: Kentuckiana Center for Better Bone and Joint Health

location_facility: Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych

location_facility: Instituto Jalisciense de Investigacion Clinica

location_facility: McGill University Health Centre, Montreal General Hospital

location_facility: University of Puerto Rico Medical Center

location_facility: Centre Hospitalier Universitarie (CHU) - PURPAA

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

location_facility: Azienda Ospedaliero University-Santa Maria della Misericordia

location_facility: Klinika Reumatologii im Prof. Eleonory Reicher

location_facility: Universitatsklinik Schleswig-Holstein, Campus Kiel

location_facility: Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin

location_facility: Palmetto Clinical Trial at Piedmont Arthritis Clinic

location_facility: Beilinson Hospital, Rabin Medical Center

location_facility: Centre for Prognosis Studies in Rheaumatic Diseases

location_facility: Gabinety Profesorow Osrodek Baden Klinicznych

location_facility: University of Miami-Division of Rheumatology and Immunology

location_facility: Low Country Rheumatology, PA/Low Country Research Center

location_facility: Instituto de Seguridad Social del Estado de Mexico y Municipios

location_facility: The University of Arizona Arthritis Center

location_facility: A. O. Ospedaliera-Universitaria Arcispedale

location_facility: University of Michigan Medical Center - Regents of University of Michigan

location_facility: Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique

location_facility: Southwest Florida Clinical Research Center

location_facility: Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik

location_facility: The Rheumatic Disease Clinical Research Center

location_facility: Rheumatology Associates of Central Florida

location_facility: North Shore-LIJ Health System/Rheumatology and Allergy Clinic

location_facility: University of Texas - Southwestern Medical Center

location_facility: Oklahoma Center For Arthritis Therapy & Research

location_facility: Hospital Regional 1o de Octubre - ISSSTE

location_facility: Hospital Regional Universitario de SAS - Carlos Haya

location_facility: Hospital Central de S.L.P. "Iganico Morones Prieto"

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Texas Tech University Health Sciences Center

location_facility: Szpital Uniwerytecki nr Zim. dr. Jana Biziela


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease

summary: This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

lead_sponsor: Novartis

location_country:
Brazil
Portugal
United Kingdom
Italy
Netherlands
Canada
United States
France
Germany