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.

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, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom 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.

publisher_dissemination: Springer

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.

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

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


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Medical Association

lead_sponsor: Newron Pharmaceuticals SPA

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

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály

location_facility: University Health Network -Toronto Western Hosp.

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

location_facility: Charité Campus Virchow Universitaetsmedizin Berlin

location_facility: Fakultna nemocnica Trnava Interna klinika

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Vseobecna nemocnica s poliklinikou Levoca

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

location_facility: Parkinson's Disease Treatment Center of SW Florida

location_facility: Northwestern University PD and Movement Disorders Center

location_facility: Institute for Neurodegenerative Disorders

location_facility: Clinexpert Kereskedelmi es Szolgaltato Kft.

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

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

location_facility: University Of South Florida Medical Center

location_facility: Nestatne zdravotnicke zariadenie Neurologicka ambulancia

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Parkinson's Disease and Movement Disorder Center

location_facility: CHU Nantes Hôpital Laennec - CIC Neurologie

location_facility: Sopron Medical Egeszsegugyi Szolgaltato Kft.

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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.

oa_host_type: publisher

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

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.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

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. Erratum In: J Antimicrob Chemother. 2016 Jun;71(6):1748-9.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

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.

oa_colors: green other

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_concat: 37720k445;PubMed Central

publisher_dissemination: American Society for Microbiology

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

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


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:
Germany
Italy
Denmark
United States
Canada
France

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.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Indiana University - IUScholarWorks

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: IOS Press

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.

oa_colors: green gold

license: cc-by

license_normalized: cc-by

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Springer-Nature

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 gamma-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.

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

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.

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

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.


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

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.

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.

status: Terminated

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

type: EudraCT Number

source: euctr

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

status_simplified: Unknown


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.

design_allocation: Non-Randomized

ReferenceCitation: Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Goncalves 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.

license: publisher-specific-oa

license_normalized: publisher-specific

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

location_country:
United States
Israel
Poland
France


lead_sponsor: Ipsen

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.

location_facility: Unità Spinale, Azienda Ospedaliera Careggi

location_facility: CH Régional Huy - Polyclinique A Rue Trois Ponts

location_facility: Erasmus MC, Universitair Medisch Centrum Rotterdam

location_facility: Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon

location_facility: General Urology Academisch Ziekenhuis Maastricht

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.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
Czechia
France


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, Garcia-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):657. doi: 10.3390/cancers12030657.

repository_institution: MDPI AG - MDPI

repositories_concat: PubMed Central;mdpi.com

repositories_institution:
MDPI AG - MDPI
PubMed Central - Europe PMC

publisher_dissemination: MDPI

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, Sjoberg 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.

repositories_concat: PubMed Central;iris.uniroma1.it

ReferenceCitation: Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomy R, Prausova J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kroning H, Humblet Y, Gravalos 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, Lakomy R, Prausova 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, Prausova 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. doi: 10.1200/JCO.2012.42.8201. Epub 2012 Sep 4.

lead_sponsor: Sanofi

collaborators:
Regeneron Pharmaceuticals
NSABP Foundation Inc

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals
NSABP Foundation Inc

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

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 840085

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 152005

location_facility: Sanofi-Aventis Investigational Site Number 840501

location_facility: Sanofi-Aventis Investigational Site Number 203001

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 840078

location_facility: Sanofi-Aventis Investigational Site Number 840701

location_facility: Sanofi-Aventis Investigational Site Number 840096

location_facility: Sanofi-Aventis Investigational Site Number 300002

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 792002

location_facility: Sanofi-Aventis Investigational Site Number 840114

location_facility: Sanofi-Aventis Investigational Site Number 410003

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 840086

location_facility: Sanofi-Aventis Investigational Site Number 804006

location_facility: Sanofi-Aventis Investigational Site Number 826009

location_facility: Sanofi-Aventis Investigational Site Number 826008

location_facility: Sanofi-Aventis Investigational Site Number 840106

location_facility: Sanofi-Aventis Investigational Site Number 642001

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 152004

location_facility: Sanofi-Aventis Investigational Site Number 840019

location_facility: Sanofi-Aventis Investigational Site Number 840606

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 792005

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 076005

location_facility: Sanofi-Aventis Investigational Site Number 032006

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 642004

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 840119

location_facility: Sanofi-Aventis Investigational Site Number 840079

location_facility: Sanofi-Aventis Investigational Site Number 840052

location_facility: Sanofi-Aventis Investigational Site Number 840801

location_facility: Sanofi-Aventis Investigational Site Number 076002

location_facility: Sanofi-Aventis Investigational Site Number 840084

location_facility: Sanofi-Aventis Investigational Site Number 840506

location_facility: Sanofi-Aventis Investigational Site Number 032003

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 724006

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 380007

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 840021

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 826011

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 840601

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 642002

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 036007

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location_facility: Sanofi-Aventis Investigational Site Number 528002

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location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 840113

location_facility: Sanofi-Aventis Investigational Site Number 076006

location_facility: Sanofi-Aventis Investigational Site Number 410004

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 840095

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 642007

location_facility: Sanofi-Aventis Investigational Site Number 840112

location_facility: Sanofi-Aventis Investigational Site Number 032007

location_facility: Sanofi-Aventis Investigational Site Number 040001

location_facility: Sanofi-Aventis Investigational Site Number 840093

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 840080

location_facility: Sanofi-Aventis Investigational Site Number 554010

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 840037

location_facility: Sanofi-Aventis Investigational Site Number 840049

location_facility: Sanofi-Aventis Investigational Site Number 840101

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 840087

location_facility: Sanofi-Aventis Investigational Site Number 642003

location_facility: Sanofi-Aventis Investigational Site Number 840089

location_facility: Sanofi-Aventis Investigational Site Number 840071

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 616006

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 578003

location_facility: Sanofi-Aventis Investigational Site Number 300005

location_facility: Sanofi-Aventis Investigational Site Number 642006

location_facility: Sanofi-Aventis Investigational Site Number 152003

location_facility: Sanofi-Aventis Investigational Site Number 276003

location_facility: Sanofi-Aventis Investigational Site Number 056005

location_facility: Sanofi-Aventis Investigational Site Number 826001

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 840043

location_facility: Sanofi-Aventis Investigational Site Number 840118

location_facility: Sanofi-Aventis Investigational Site Number 036005

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 840070

location_facility: Sanofi-Aventis Investigational Site Number 840081

location_facility: Sanofi-Aventis Investigational Site Number 840074

location_facility: Sanofi-Aventis Investigational Site Number 840115

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 826003

location_facility: Sanofi-Aventis Investigational Site Number 804002

location_facility: Sanofi-Aventis Investigational Site Number 840094

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 076001

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 724005

location_facility: Sanofi-Aventis Investigational Site Number 036006

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 616003

location_facility: Sanofi-Aventis Investigational Site Number 032005

location_facility: Sanofi-Aventis Investigational Site Number 840076

location_facility: Sanofi-Aventis Investigational Site Number 840088

location_facility: Sanofi-Aventis Investigational Site Number 840031

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 380006

location_facility: Sanofi-Aventis Investigational Site Number 804004

location_facility: Sanofi-Aventis Investigational Site Number 840073

location_facility: Sanofi-Aventis Investigational Site Number 840048

location_facility: Sanofi-Aventis Investigational Site Number 300004

location_facility: Sanofi-Aventis Investigational Site Number 710004

location_facility: Sanofi-Aventis Investigational Site Number 840406

location_facility: Sanofi-Aventis Investigational Site Number 076007

location_facility: Sanofi-Aventis Investigational Site Number 826007

location_facility: Sanofi-Aventis Investigational Site Number 076004

location_facility: Sanofi-Aventis Investigational Site Number 840206

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 554009

location_facility: Sanofi-Aventis Investigational Site Number 578001

location_facility: Sanofi-Aventis Investigational Site Number 840301

location_facility: Sanofi-Aventis Investigational Site Number 840116

location_facility: Sanofi-Aventis Investigational Site Number 840098

location_facility: Sanofi-Aventis Investigational Site Number 710007

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 076008

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 840035

location_facility: Sanofi-Aventis Investigational Site Number 616007

location_facility: Sanofi-Aventis Investigational Site Number 630001

location_facility: Sanofi-Aventis Investigational Site Number 840047

location_facility: Sanofi-Aventis Investigational Site Number 642005

location_facility: Sanofi-Aventis Investigational Site Number 840201

location_facility: Sanofi-Aventis Investigational Site Number 208001

location_facility: Sanofi-Aventis Investigational Site Number 410002

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 840906

location_facility: Sanofi-Aventis Investigational Site Number 076003

location_facility: Sanofi-Aventis Investigational Site Number 804005

location_facility: Sanofi-Aventis Investigational Site Number 203004

location_facility: Sanofi-Aventis Investigational Site Number 840097

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 840117

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 826010

location_facility: Sanofi-Aventis Investigational Site Number 710008

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 840120

location_facility: Sanofi-Aventis Investigational Site Number 840122

location_facility: Sanofi-Aventis Investigational Site Number 840014

location_facility: Sanofi-Aventis Investigational Site Number 840401

location_facility: Sanofi-Aventis Investigational Site Number 840004

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location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 056007

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 826004

location_facility: Sanofi-Aventis Investigational Site Number 840806

location_facility: Sanofi-Aventis Investigational Site Number 840044

location_facility: Sanofi-Aventis Investigational Site Number 840072

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 300001

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 208003

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 840706

location_facility: Sanofi-Aventis Investigational Site Number 380008

location_facility: Sanofi-Aventis Investigational Site Number 578002

location_facility: Sanofi-Aventis Investigational Site Number 410005

location_facility: Sanofi-Aventis Investigational Site Number 840901

location_facility: Sanofi-Aventis Investigational Site Number 840099

location_facility: Sanofi-Aventis Investigational Site Number 840075

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 840046

location_facility: Sanofi-Aventis Investigational Site Number 840053

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 840306

location_facility: Sanofi-Aventis Investigational Site Number 410001

location_facility: Sanofi-Aventis Investigational Site Number 840042

location_facility: Sanofi-Aventis Investigational Site Number 300003

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 840034


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.

publisher_dissemination: Wolters Kluwer Health

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

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

location_facility: Cliniques Universitaires Saint-Luc, Universite Catholique de

location_facility: AKH University of Vienna, Medical University

location_facility: Katedra IKlinika Neurochirurgii Akademii Medycznej w Warszawie Clinic

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Scientific Research Institute of Neurosurgery by Burdenko

location_facility: Landeskrankenhaus und Medizinische Universitat Graz

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

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

location_facility: University Fur Neurochirurgie, SALK, Christian Doppler Hospital

location_facility: Katedra Klinika Neurochirurgii Akademii Medycznej w Gdansku

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

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

location_facility: Toronto Western Hospital, University of Toronto

location_facility: Klinika Neurochirurgii AMB-Neurosurgery Clinic of Medical Academy

location_facility: University of Calgary Foothills Medical Center

location_facility: Hopital Neurologique et Neuro-Chirurgical Pierre Wertheimer

location_facility: All India Insititute of Medicla Sciences (AIIMS)

location_facility: Katedra I Klinika Neurochirurgii i Dzieciecej

location_facility: University of Cincinnati-Department of Neurosurgery

location_facility: University Hospitals Case Medical Center-Department of Neurosurgery

location_facility: Oregon Health & Science University-Oregon Stroke Center

location_facility: Uppsala University Hospital-Uppsala Akademiska Sjukhus

location_facility: Haukeland University Hospital Helse Bergen HF

location_facility: Charite Universitatsmedizin Berlin-Neurochirurgische Klinik-CVK

location_facility: Guangdong Province Chinese Medicine Hospital

location_facility: Universitätsklinik Bern Klinik für Neurochirurgie

location_facility: A. P. Romodanov Institute of Neurosurgery

location_facility: XuanWu Hospital Institute of Brain Vascular Disease

location_facility: Riga Eastern Clinical University Hospital

location_facility: Thechnical University-Klinikum rechts der Isar

location_facility: University of Virginia Health System-Department of Neurosurgery

location_facility: Neurochirurggische Universitatsklinik des Heidelberg

location_facility: Azienda Ospedaliero-Universitaria di Careggi

location_facility: Universitatsklinik Frankfurt, Klinik und Poliklinik fur Neurochirurgie

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

location_facility: Virginia Commonwealth University-Department of Neurosurgery

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Slaskiej Akademii Medycznej w Katowicach


lead_sponsor: ACADIA Pharmaceuticals Inc.

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

ReferenceType: background

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.

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.

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

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


lead_sponsor: Novo Nordisk A/S

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.

ReferenceType: result

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.

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

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


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).

lead_sponsor: Eli Lilly and Company

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

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Sant Joan de Déu-Hospital Clinic

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: General University Hospital Gregorio Marañón

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clínico Universitario de Santiago de Compostela

lead_sponsor_type: academique


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.

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.

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, Videbaek 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, Brandle 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. doi: 10.4158/ep.17.6.906.

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. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Davidson JA, Orsted 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.

publisher_dissemination: Wiley

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.

version: acceptedVersion

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

location_country: Macedonia, The Former Yugoslav Republic of


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.

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

lead_sponsor: UCB Pharma

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


lead_sponsor: AbbVie (prior sponsor, Abbott)

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.

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

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

location_country:
Germany
Italy
Mexico
United States
Canada
Puerto Rico
France


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


intervention_type: Biological

lead_sponsor: Janssen Research & Development, LLC

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).

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, Jarnerot 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.

sponsor_collaborators:
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC

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

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


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

sponsor_collaborators:
UCB Pharma
Biogen

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


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


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:
Germany
Australia
Mexico
United States
Peru
Puerto Rico
France


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:
Argentina
Australia
Mexico
South Africa
France


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


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.

study_start_date_type: Actual

ReferenceCitation: de Boer RH, Arrieta O, 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:
Germany
Argentina
Australia
France
Colombia
Portugal
Hong Kong
United States
India
Belgium
Philippines
Italy
United Kingdom
Venezuela
Sweden
Mexico
Spain
Greece
South Africa
Taiwan
Israel


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.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

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: Yes

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

sponsor_collaborators:
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd

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

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

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

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Huashan Hospital, Insitute of Antibiotics

location_facility: Upstate Infectious Diseases Association LLP

location_facility: The Third Xiangya Hospital of Central South University

location_facility: The Affiliated Union Hospital of Fujian Medical University

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Charité Universitaetsmedizin Berlin- Campus Charité Mitte

location_facility: The 1st Affiliated Hospital of Guangxi Medical University

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

location_facility: Hospital Universitario Clementino Fraga Filho

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: University of California at San Francisco

location_facility: West China Hospital of Sichuan University

location_facility: Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi

location_facility: Tata Memorial Hopital, Department of Anesthesia

location_facility: Republican Hospital named after V.A. Baranov


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.

ReferenceCitation: Ison MG, Szakaly P, Shapira MY, Krivan 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.

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

primary_purpose: Prevention

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


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):e001747. doi: 10.1136/rmdopen-2021-001747.

repositories_concat: PubMed Central;digitalcommons.wustl.edu

publisher_dissemination: British Medical Journal

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):e000459. doi: 10.1136/lupus-2020-000459.

ReferenceCitation: Gomez A, Hani Butrus F, Johansson P, Akerstrom 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.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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, Tegzova 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. doi: 10.3899/jrheum.111587. 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, Tegzova 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.

sponsor_collaborators:
Human Genome Sciences Inc.
GlaxoSmithKline

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

location_facility: Arthritis Associates of Colorado Springs

location_facility: Rheumatology Associates of Central Florida

location_facility: The University of Arizona Arthritis Center

location_facility: Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin

location_facility: Hospital Regional Universitario de SAS - Carlos Haya

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

location_facility: University of Miami-Division of Rheumatology and Immunology

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

location_facility: Centre for Prognosis Studies in Rheaumatic Diseases

location_facility: Palmetto Clinical Trial at Piedmont Arthritis Clinic

location_facility: Azienda Ospedaliero University-Santa Maria della Misericordia

location_facility: Oklahoma Center For Arthritis Therapy & Research

location_facility: Instituto Jalisciense de Investigacion Clinica

location_facility: A. O. Ospedaliera-Universitaria Arcispedale

location_facility: Arizona Arthritis and Rheumatology Research, PPLC

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

location_facility: University of Texas - Southwestern Medical Center

location_facility: University of North Carolina at Chapel Hill

location_facility: McGill University Health Centre, Montreal General Hospital

location_facility: Texas Tech University Health Sciences Center

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

location_facility: Arthritis and Rheumatic Disease Specialties

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

location_facility: Southwest Florida Clinical Research Center

location_facility: Centre Hospitalier Universitarie (CHU) - PURPAA

location_facility: Universitatsklinik Schleswig-Holstein, Campus Kiel

location_facility: Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique

location_facility: Hospital Regional 1o de Octubre - ISSSTE

location_facility: Washington University School of Medicine

location_facility: Beilinson Hospital, Rabin Medical Center

location_facility: Klinika Reumatologii im Prof. Eleonory Reicher

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

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: The Rheumatic Disease Clinical Research Center

location_facility: Kentuckiana Center for Better Bone and Joint Health

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

location_facility: Szpital Uniwerytecki nr Zim. dr. Jana Biziela

location_facility: Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych

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

location_facility: University of Puerto Rico Medical Center

location_facility: Gabinety Profesorow Osrodek Baden Klinicznych

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


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


lead_sponsor: Celgene Corporation

summary: The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

ReferenceCitation: Dimopoulos MA, Delforge M, Hajek R, Kropff M, Petrucci MT, Lewis P, Nixon A, Zhang J, Mei J, Palumbo A. Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial. Haematologica. 2013 May;98(5):784-8. doi: 10.3324/haematol.2012.074534. Epub 2012 Dec 14.

ReferenceCitation: Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, Gisslinger H, Wiktor-Jedrzejczak W, Zodelava M, Weisel K, Cascavilla N, Iosava G, Cavo M, Kloczko J, Blade J, Beksac M, Spicka I, Plesner T, Radke J, Langer C, Ben Yehuda D, Corso A, Herbein L, Yu Z, Mei J, Jacques C, Dimopoulos MA; MM-015 Investigators. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012 May 10;366(19):1759-69. doi: 10.1056/NEJMoa1112704. Erratum In: N Engl J Med. 2012 Jul 19;367(3):285.

ReferenceCitation: Dimopoulos MA, Petrucci MT, Foa R, Catalano J, Kropff M, Terpos E, Zhang J, Grote L, Jacques C, Palumbo A; MM-015 Investigators. Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point. Haematologica. 2015 Aug;100(8):e328-30. doi: 10.3324/haematol.2014.120790. Epub 2015 Apr 3. No abstract available.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories_concat: PubMed Central;iris.unito.it

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg

location_facility: Medical Radiological Research Center RAMS

location_facility: Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: University Hospital of Salzburg St Johanns Spital

location_facility: Divisione Di Ematologia Ospedale Cattedra di Ematologia

location_facility: Institute of Urgent and Recovery Surgery

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Hospital Universitaro Puerta del MarServicio de Hematologia

location_facility: Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital Virgen del Rocio Servicio de Hematologia

location_facility: University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital

location_facility: Assistance Publique - Hôpitaux de Paris AP-HP

location_facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

location_facility: G. GENNIMATAS General Hospital of Athens Department of Hematolgosy

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Medizinische Klinik und Poliklinik II der Charite Campus Mitte

location_facility: Hope Directorate Haematology Oncology Service St. James Hospital

location_facility: Moscow Regional Research Institute n.a. Vladimirsky

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: UniversitatsSpital ZurichKlinik fur Onkologie

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

location_facility: Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda

location_facility: Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology

location_facility: Institute of Internal Diseases University of Medicine

title: A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years Of Age Or Older

location_country:
Germany
Ireland
Poland
Australia
Turkey
France
Czech Republic
Belarus
Denmark
Switzerland
Ukraine
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Georgia
Russian Federation
Israel


title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation

summary: Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.

ReferenceCitation: Jerry Snidow, Hugh Miller, Guillermo Valenzuela, Steve Thornton, Brendt Stier, Linda Clayton, Michael Fossler, Timothy Montague, Kathleen Beach, Pauline Williams. A Multicenter, Randomized, Double-blind Placebo-controlled Phase II Trial of Retosiban, a Selective Oxytocin Receptor Antagonist, for the Management of Preterm Labor. Am J Obstet Gynecol. 2013;2:S155.

ReferenceCitation: Thornton S, Valenzuela G, Baidoo C, Fossler MJ, Montague TH, Clayton L, Powell M, Snidow J, Stier B, Soergel D. Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose-ranging study. Br J Clin Pharmacol. 2017 Oct;83(10):2283-2291. doi: 10.1111/bcp.13336. Epub 2017 Jul 11.

ReferenceCitation: Thornton S, Miller H, Valenzuela G, Snidow J, Stier B, Fossler MJ, Montague TH, Powell M, Beach KJ. Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study. Br J Clin Pharmacol. 2015 Oct;80(4):740-9. doi: 10.1111/bcp.12646. Epub 2015 Jun 1. Erratum In: Br J Clin Pharmacol. 2015 Sep;80(3):609.

location_country:
Lithuania
Colombia
United Kingdom
Argentina
Singapore
United States
Korea, Republic of
Spain
Bulgaria
Puerto Rico
France


summary: The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.

ReferenceCitation: Orlowski RZ, Gercheva L, Williams C, Sutherland H, Robak T, Masszi T, Goranova-Marinova V, Dimopoulos MA, Cavenagh JD, Spicka I, Maiolino A, Suvorov A, Blade J, Samoylova O, Puchalski TA, Reddy M, Bandekar R, van de Velde H, Xie H, Rossi JF. A phase 2, randomized, double-blind, placebo-controlled study of siltuximab (anti-IL-6 mAb) and bortezomib versus bortezomib alone in patients with relapsed or refractory multiple myeloma. Am J Hematol. 2015 Jan;90(1):42-9. doi: 10.1002/ajh.23868.

title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade Versus Velcade Alone in Subjects With Relapsed or Refractory Multiple Myeloma

location_country:
Germany
Poland
Bulgaria
Portugal
Slovakia
Hungary
United Kingdom
Romania
Brazil
Netherlands
Belgium
United States
Spain
Greece
Czechia
Canada
Russian Federation
France


title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome

summary: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.

primary_purpose: Diagnostic

location_country: Germany Australia France


title: A Randomized, Double-blind, Placebo Controlled, Multicentre, Phase II Study of Oral Lapatinib in Combination With Concurrent Radiotherapy and Cisplatin Versus Radiotherapy and Cisplatin Alone, in Subjects With Stage III, IVA, B Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.

ReferenceCitation: Harrington K, Berrier A, Robinson M, Remenar E, Housset M, de Mendoza FH, Fayette J, Mehanna H, El-Hariry I, Compton N, Franklin N, Biswas-Baldwin N, Lau M, Legenne P, Kumar R. Randomised Phase II study of oral lapatinib combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck: rationale for future randomised trials in human papilloma virus-negative disease. Eur J Cancer. 2013 May;49(7):1609-18. doi: 10.1016/j.ejca.2012.11.023. Epub 2012 Dec 19.

ReferenceCitation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

location_country:
India
Hungary
United Kingdom
Netherlands
United States
Spain
Peru
Canada
France