title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

summary: This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

location_country:
United Kingdom
Greece
Canada
United States
France
South Africa
Germany

location_facility:
Site Reference ID/Investigator# 68764
Site Reference ID/Investigator# 68706
Site Reference ID/Investigator# 67787
Site Reference ID/Investigator# 67783
Site Reference ID/Investigator# 66525
Site Reference ID/Investigator# 68705
Site Reference ID/Investigator# 67786
Site Reference ID/Investigator# 66528
Site Reference ID/Investigator# 68733
Site Reference ID/Investigator# 68732
Site Reference ID/Investigator# 66526
Site Reference ID/Investigator# 69959
Site Reference ID/Investigator# 68731
Site Reference ID/Investigator# 71798
Site Reference ID/Investigator# 71795
Site Reference ID/Investigator# 68765
Site Reference ID/Investigator# 69960
Site Reference ID/Investigator# 66523
Site Reference ID/Investigator# 77833
Site Reference ID/Investigator# 68767
Site Reference ID/Investigator# 66522
Site Reference ID/Investigator# 67785
Site Reference ID/Investigator# 68730
Site Reference ID/Investigator# 71796
Site Reference ID/Investigator# 67585
Site Reference ID/Investigator# 67583
Site Reference ID/Investigator# 66527
Site Reference ID/Investigator# 66531
Site Reference ID/Investigator# 68704
Site Reference ID/Investigator# 67582
Site Reference ID/Investigator# 66524
Site Reference ID/Investigator# 67584
Site Reference ID/Investigator# 69602
Site Reference ID/Investigator# 68768
Site Reference ID/Investigator# 71793
Site Reference ID/Investigator# 68729
Site Reference ID/Investigator# 66530
Site Reference ID/Investigator# 71794
Site Reference ID/Investigator# 67784
Site Reference ID/Investigator# 68735
Site Reference ID/Investigator# 66529
Site Reference ID/Investigator# 71573
Site Reference ID/Investigator# 67586


type: EudraCT Number

title: A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: CSL Behring

location_country:
Poland
Taiwan
Hong Kong
United Kingdom
Italy
Austria
Netherlands
Canada
Switzerland
Hungary
Korea, Republic of
United States
France
India
Israel
Mexico
Germany
Czechia

location_facility: Premier Medical Group Of The Hudson Valley, Pc

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary:
Primary Objective:

- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;

Secondary Objectives:

To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
To evaluate the durability of splenic response
To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
To evaluate the splenic response to SAR302503 at the end of Cycle 3
To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
To evaluate the safety and tolerability of SAR302503 in this population
To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

status: Completed

ReferenceType: derived

ReferenceCitation: Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Tiu RV, Zachee P, Jourdan E, Winton E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Lager J, Shun Z, Mesa RA. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324. doi: 10.1016/S2352-3026(17)30088-1. Epub 2017 Jun 8.

lead_sponsor: Sanofi

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

location_facility:
Investigational Site Number 250003
Investigational Site Number 056002
Investigational Site Number 380002
Investigational Site Number 040001
Investigational Site Number 840001
Investigational Site Number 528003
Investigational Site Number 840019
Investigational Site Number 840022
Investigational Site Number 528002
Investigational Site Number 380001
Investigational Site Number 380003
Investigational Site Number 840004
Investigational Site Number 250002
Investigational Site Number 276007
Investigational Site Number 840013
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 250001
Investigational Site Number 276005
Investigational Site Number 840007
Investigational Site Number 840009
Investigational Site Number 724001
Investigational Site Number 840024
Investigational Site Number 380004
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 826001
Investigational Site Number 276003
Investigational Site Number 840018
Investigational Site Number 528001
Investigational Site Number 840015
Investigational Site Number 040002
Investigational Site Number 124001
Investigational Site Number 840002
Investigational Site Number 276006
Investigational Site Number 056003
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 840017

intervention_type: Drug

status_simplified: Completed


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

acronym: C-early

summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

ReferenceType: result

ReferenceCitation: Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.

ReferenceCitation: Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.

lead_sponsor: UCB Pharma

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Argentina
Monaco
Mexico
Sweden
Canada
Switzerland
Hungary
Germany
Ireland
France
Colombia
Netherlands


summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

lead_sponsor: UCB Pharma SA


title: A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

lead_sponsor: Novartis Pharmaceuticals

source: euctr

design_allocation: Non-Randomized

ReferenceCitation: Sommerwerck U, Virella-Lowell I, Angyalosi G, Viegas A, Cao W, Debonnett L. Long-term safety of tobramycin inhalation powder in patients with cystic fibrosis: phase IV (ETOILES) study. Curr Med Res Opin. 2016 Nov;32(11):1789-1795. Epub 2016 Sep 9.

location_country:
Spain
Italy
Australia
Argentina
Canada
Hungary
United States
France
Mexico
Germany

summary: This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.


title: A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

summary: This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

ReferenceCitation: Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

lead_sponsor: Gilead Sciences

location_country:
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Infectious Diseases Associates of Northwest Florida

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: La Playa Medical Group and Clinical Research

location_facility: Tarrant County Infectious Disease Associates

location_facility: Azienda Ospedaliera Ospedale di Circolo Busto Arsizio

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Southwest Infectious Disease Clinical Researach Inc

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: HIV Program Hennepin County Medical Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Clinical Alliance for Research & Education - Infectious Disease

location_facility: SEAMEO Regional Centre for Tropical Medicine


title: Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.

acronym: ATTRACT

summary:
Study objectives:

To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

lead_sponsor: Galderma R&D

location_country:
Poland
United Kingdom
Russian Federation
Czech Republic
Ukraine
Hungary
France
Romania
Germany
Bulgaria

location_facility:
Galderma Invetigational site
Galderma Investigational Site


title: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

acronym: TRACE

summary: The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Austria
United States
France
Germany
Czechia

location_facility: Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere


title: Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator

summary: This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

study_completion_date_type: Anticipated

lead_sponsor: Forest Laboratories

location_country:
Denmark
Poland
Spain
Italy
Netherlands
Canada
Czech Republic
Sweden
United States
France
Israel
Belgium
Germany

location_facility:
Forest Investigative Site 706
Forest Investigative Site 705
Forest Investigative Site 353
Forest Investigative Site 044
Forest Investigative Site 851
Forest Investigative Site 124
Forest Investigative Site 075
Forest Investigative Site 804
Forest Investigative Site 604
Forest Investigative Site 070
Forest Investigative Site 050
Forest Investigative Site 550
Forest Investigative Site 552
Forest Investigative Site 358
Forest Investigative Site 405
Forest Investigative Site 076
Forest Investigative Site 042
Forest Investigative Site 504
Forest Investigative Site 754
Forest Investigative Site 094
Forest Investigative Site 116
Forest Investigative Site 087
Forest Investigative Site 267
Forest Investigative Site 069
Forest Investigative Site 106
Forest Investigative Site 056
Forest Investigative Site 083
Forest Investigative Site 350
Forest Investigative Site 107
Forest Investigative Site 854
Forest Investigative Site 850
Forest Investigative Site 112
Forest Investigative Site 089
Forest Investigative Site 012
Forest Investigative Site 023
Forest Investigative Site 601
Forest Investigative Site 751
Forest Investigative Site 123
Forest Investigative Site 007
Forest Investigative Site 303
Forest Investigative Site 118
Forest Investigative Site 003
Forest Investigative Site 004
Forest Investigative Site 453
Forest Investigative Site 028
Forest Investigative Site 302
Forest Investigative Site 452
Forest Investigative Site 121
Forest Investigative Site 084
Forest Investigative Site 252
Forest Investigative Site 264
Forest Investigative Site 010
Forest Investigative Site 109
Forest Investigative Site 750
Forest Investigative Site 117
Forest Investigative Site 041
Forest Investigative Site 022
Forest Investigative Site 079
Forest Investigative Site 062
Forest Investigative Site 801
Forest Investigative Site 250
Forest Investigative Site 451
Forest Investigative Site 029
Forest Investigative Site 072
Forest Investigative Site 125
Forest Investigative Site 035
Forest Investigative Site 357
Forest Investigative Site 074
Forest Investigative Site 008
Forest Investigative Site 052
Forest Investigative Site 802
Forest Investigative Site 006
Forest Investigative Site 055
Forest Investigative Site 269
Forest Investigative Site 354
Forest Investigative Site 058
Forest Investigative Site 301
Forest Investigative Site 095
Forest Investigative Site 253
Forest Investigative Site 018
Forest Investigative Site 502
Forest Investigative Site 081
Forest Investigative Site 090
Forest Investigative Site 015
Forest Investigative Site 063
Forest Investigative Site 066
Forest Investigative Site 259
Forest Investigative Site 059
Forest Investigative Site 016
Forest Investigative Site 805
Forest Investigative Site 852
Forest Investigative Site 262
Forest Investigative Site 401
Forest Investigative Site 005
Forest Investigative Site 555
Forest Investigative Site 800
Forest Investigative Site 048
Forest Investigative Site 119
Forest Investigative Site 113
Forest Investigative Site 020
Forest Investigative Site 068
Forest Investigative Site 410
Forest Investigative Site 752
Forest Investigative Site 111
Forest Investigative Site 304
Forest Investigative Site 092
Forest Investigative Site 024
Forest Investigative Site 060
Forest Investigative Site 053
Forest Investigative Site 753
Forest Investigative Site 803
Forest Investigative Site 043
Forest Investigative Site 030
Forest Investigative Site 034
Forest Investigative Site 049
Forest Investigative Site 254
Forest Investigative Site 300
Forest Investigative Site 450
Forest Investigative Site 406
Forest Investigative Site 110
Forest Investigative Site 088
Forest Investigative Site 091
Forest Investigative Site 013
Forest Investigative Site 100
Forest Investigative Site 065
Forest Investigative Site 853
Forest Investigative Site 402
Forest Investigative Site 082
Forest Investigative Site 045
Forest Investigative Site 085
Forest Investigative Site 046
Forest Investigative Site 122
Forest Investigative Site 073
Forest Investigative Site 071
Forest Investigative Site 270
Forest Investigative Site 064
Forest Investigative Site 014
Forest Investigative Site 263


title: Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

summary: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

study_start_date_type: Actual

ReferenceCitation: Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.

ReferenceCitation: Everson GT, Sims KD, Rodriguez-Torres M, Hézode C, Lawitz E, Bourlière M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.

lead_sponsor: Bristol-Myers Squibb

location_country:
Puerto Rico
United States
France

location_facility: Va Greater Los Angeles Healthcare System

location_facility: University Of Colorado Denver And Hospital

location_facility: Atlanta Gastroenterology Associates, Llc


title: PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects

acronym: PROTEA

summary: The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

ReferenceCitation: Girard PM, Antinori A, Arribas JR, Ripamonti D, Bicer C, Netzle-Sveine B, Hadacek B, Moecklinghoff C. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017 Jan;18(1):5-12. doi: 10.1111/hiv.12386. Epub 2016 Jun 9.

lead_sponsor: Janssen-Cilag International NV

location_country:
Denmark
Poland
Spain
Ireland
Austria
United Kingdom
Switzerland
Sweden
Hungary
France
Israel
Belgium
Germany


title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

summary: The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

ReferenceType: background

ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. Review.

lead_sponsor: Amgen

location_country:
Poland
Italy
Russian Federation
Mexico
Netherlands
New Zealand
Hungary
France
United States
Belgium
Germany
Slovakia
Czechia


title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Of Lurasidone For The Maintenance Treatment Of Subjects With Schizophrenia

summary: Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

lead_sponsor: Sunovion

location_country:
Serbia
Italy
Russian Federation
United States
France
South Africa
Slovakia

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: SC SPDC-Edificio n. 7, Ospedale S. Andrea

location_facility: Specialized Hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Psychiatricke oddelenie, Nemocnica s poliklinikou sv. Barbory Roznava, a.s.

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: Limited Liability Company (LLC) Research Center for Treatment and rehabilitation "Phoenix"

location_facility: Hopital Chalucet, Centre hospitalier intercommunal de toulon la Seyne sur mer (CHITS)

location_facility: Psychiaticke oddelenie Vseobecna nemocnica Riimavska Sobota, NaP n.o.

location_facility: Behavioral Medical Research of Staten Island

location_facility: University of New York, Dept. of Psychiatry

location_facility: Military Medical Academy, Clinic for Psychiatry

location_facility: St. Petersburg State Healthcare Institution (SPbSH) "City Psychiatric Hospital #6"

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: St. Petersburg State Government Healthcare Institution City Psychiatric Hospital #4 (St. Petersburg Insane Asylum Distributor)

location_facility: Nemonnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: Centre Hospitalier Specialise du Jura - Centre Medico Psychiatric

location_facility: Regional Government Institution Kipetsk Regional Psychoneurology Hospital

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

location_facility: Clinical Centre Kragujevac, Clinic for Psychiatry

location_facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

location_facility: California Neuropsychopharmacology Clinical Research Instit

location_facility: Medical Research Group of Central Florida

location_facility: Clinical Centre Vojvodina, Clinic for Psychiatry

location_facility: Center for Psychiatry and Behavioral Medicine, Inc.

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: St. Petersburg State Budgetary Healthcare Institution City Psychoneurology Dispensary #7 (with in-patient dept.) (SPb SBHI CPNDD-7), at daycare facility #1

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia


type: Registry Identifier

title: A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.

summary: The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.

status: Active, not recruiting

ReferenceCitation: Rasco DW, Papadopoulos KP, Pourdehnad M, Gandhi AK, Hagner PR, Li Y, Wei X, Chopra R, Hege K, DiMartino J, Shih K. A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies. Clin Cancer Res. 2019 Jan 1;25(1):90-98. doi: 10.1158/1078-0432.CCR-18-1203. Epub 2018 Sep 10.

ReferenceCitation: Cubillos-Zapata C, Cordoba R, Avendaño-Ortiz J, Arribas-Jiménez C, Hernández-Jiménez E, Toledano V, Villaescusa T, Moreno V, López-Collazo E. CC-122 immunomodulatory effects in refractory patients with diffuse large B-cell lymphoma. Oncoimmunology. 2016 Sep 16;5(12):e1231290. doi: 10.1080/2162402X.2016.1231290. eCollection 2016.

ReferenceCitation: Hagner P, et al. CC-122 Has Potent Anti-Lymphoma Activity through Destruction of the Aiolos and Ikaros Transcription Factors and Induction of Interferon Response Pathways. Presented at American Society of Hematology 2014, December 6-9, 2014, San Francisco, CA. Abstract No. 3035.

ReferenceCitation: Carpio C, Bouabdallah R, Ysebaert L, Sancho JM, Salles G, Cordoba R, Pinto A, Gharibo M, Rasco D, Panizo C, Lopez-Martin JA, Santoro A, Salar A, Damian S, Martin A, Verhoef G, Van den Neste E, Wang M, Couto S, Carrancio S, Weng A, Wang X, Schmitz F, Wei X, Hege K, Trotter MWB, Risueño A, Buchholz TJ, Hagner PR, Gandhi AK, Pourdehnad M, Ribrag V. Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier. Blood. 2020 Mar 26;135(13):996-1007. doi: 10.1182/blood.2019002395. Erratum in: Blood. 2021 Apr 15;137(15):2126.

lead_sponsor: Celgene

location_country:
Spain
Italy
United States
France
Belgium

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Institut universitaire du cancer de Toulouse (IUCT) - Oncopole

location_facility: Swedish Medical Center Cancer Institute Research

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Universitario Clinico de Valencia

location_facility: Weill Medical College of Cornell University

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: Henry Ford Medical Center - New Center One

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali

location_facility: Rutgers Cancer Institute of New Jersey University

status_simplified: Ongoing


title: A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

acronym: SCULPTURE

summary: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

location_country:
Poland
United Kingdom
Italy
Austria
Canada
Czech Republic
Switzerland
Vietnam
United States
France
India
Singapore
Japan
Germany
Bulgaria
Slovakia


title: A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma

summary:
Primary Objective:

- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

Secondary Objectives:

To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409
To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL
To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

ReferenceCitation: Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. Erratum in: Lancet Haematol. 2018 Jun;5(6):e240.

location_country:
Australia
Netherlands
United States
France
Belgium
Germany

location_facility:
Investigational Site Number 250003
Investigational Site Number 056002
Investigational Site Number 840001
Investigational Site Number 840104
Investigational Site Number 840006
Investigational Site Number 528003
Investigational Site Number 528002
Investigational Site Number 840012
Investigational Site Number 840004
Investigational Site Number 250002
Investigational Site Number 840013
Investigational Site Number 036001
Investigational Site Number 250005
Investigational Site Number 840007
Investigational Site Number 840011
Investigational Site Number 840010
Investigational Site Number 036005
Investigational Site Number 276003
Investigational Site Number 528001
Investigational Site Number 036003
Investigational Site Number 840015
Investigational Site Number 056001
Investigational Site Number 840002
Investigational Site Number 276002
Investigational Site Number 056003
Investigational Site Number 250004
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 250001
Investigational Site Number 036002


title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26.

location_country:
Poland
Luxembourg
Spain
Ireland
Russian Federation
United Kingdom
Ukraine
Korea, Republic of
United States
France
Belgium
Netherlands

summary: The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.


title: A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study

summary:
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
New Zealand
Thailand
Sweden
Hungary
United States
France
Turkey
Belgium
Japan
Germany

location_facility: Oregon Health & Science University Knight Cancer Institute

location_facility: University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr


title: A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

location_country:
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Canada
Puerto Rico
United States
France
India
South Africa

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

location_facility: Dean Foundation For Health Research & Education

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial

acronym: Pyxis

summary: To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

ReferenceCitation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

ReferenceCitation: McIntyre RS, Weiller E, Zhang P, Weiss C. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials. J Affect Disord. 2016 Sep 1;201:116-23. doi: 10.1016/j.jad.2016.05.013. Epub 2016 May 12.

ReferenceCitation: Thase ME, Youakim JM, Skuban A, Hobart M, Augustine C, Zhang P, McQuade RD, Carson WH, Nyilas M, Sanchez R, Eriksson H. Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants. J Clin Psychiatry. 2015 Sep;76(9):1224-31. doi: 10.4088/JCP.14m09688.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Canada
United States
France
Slovakia


title: Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

acronym: ARCHER 1009

summary: This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

ReferenceCitation: Ramalingam SS, O'Byrne K, Boyer M, Mok T, Jänne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum in: Ann Oncol. 2016 Jul;27(7):1363.

ReferenceCitation: Ramalingam SS, Jänne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15.

lead_sponsor: Pfizer

location_country:
Spain
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Austria
Russian Federation
India
Mexico
Sweden
Slovakia
Switzerland
Hungary
China
Germany
Denmark
Greece
Ireland
Finland
Korea, Republic of
France

location_facility: Hospital Provincial de Castellon - Servicio de Oncologia

location_facility: Asan Medical Center, Department of Oncology

location_facility: Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.,

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: Hospital Provincial de Castellon (Farmacia)

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Grand Hopital de Charleroi Oncologie-Hematologie

location_facility: Hospital de la Santa Creu i Sant Pau - Anatomia Patológica

location_facility: Oncology and Hematology Specialists, P.A.

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: City of Hope South Pasadena Cancer Center

location_facility: St.-Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital

location_facility: Washington University School of Medicine-IDS Pharmacy

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: UCLA Santa Monica Medical Center & Orthopedic Hospital

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet

location_facility: Krankenhaus Bethanien, Medizinische Klinik III

location_facility: Zala Megyei Korhaz, Pulmonologiai Osztaly

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Ingalls Memorial Hospital - In-Patient Pharmacy

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: Hospital Universitario 12 de Octubre-Radiology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Desert Oncology Associates dba Ironwood Cancer and Research Centers

location_facility: Winship Cancer Institute of Emory University

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.

location_facility: Specializovana nemocnica sv. Svorada Zobor, n.o.

location_facility: Good Samaritan Hospital Samaritan Ambulatory Infusion Services

location_facility: Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka

location_facility: Central Coast Medical Oncology Corporation

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Hospital General Universitario de Elche - Edificio UIAE

location_facility: University of South Alabama Medical Center

location_facility: Karmanos Cancer Institute at Farmington Hills

location_facility: Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency

location_facility: Hospital de la Santa Creu i Sant Pau - AGDAC

location_facility: Suburban Hematology-Oncology Associates, P.C.

location_facility: Institut de Cancerologie de lOuest - Rene Gauducheau

location_facility: Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)

location_facility: Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley

location_facility: National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Samaritan Hematology & Oncology Consultants

location_facility: West China Hospital of Sichuan University

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: CHU Ambroise Parre- Service Biologie Clinique

location_facility: Hematology and Oncology Consultants, P.A.

location_facility: New Cross Hospital - Royal Wolverhampton Hospital NHS Trust

location_facility: Tumour Hospital of Guangxi Zhuang Autonomous Region

location_facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4

location_facility: Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum

location_facility: Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

location_facility: City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association

location_facility: Aichi cancer center central hospital /Thoracic Oncology

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Semmelweis Egyetem Pulmonologiai Klinika

location_facility: Cancer Care Associates Medical Group Inc.

location_facility: Oncology Specialists of North Georgia, LLC

location_facility: Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman

location_facility: Samsung Medical Center, Clinical Trial Center

location_facility: Osaka City General Hospital Department of Clinical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.

location_facility: Kyushu University Hospital Respiratory Medicine

location_facility: Hospital de la Santa Creu i Sant Pau - Hospital de Día

location_facility: Investigational Drug Services, Florida Hospital

location_facility: Mercy Hospital Oklahoma City - Oncology Infusion

location_facility: Ironwood physicians P C dba Ironwood Cancer & Research Centers


title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

acronym: NURTURE 1

summary: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.

ReferenceCitation: Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

ReferenceCitation: Blanco FJ, Möricke R, Dokoupilova E, Codding C, Neal J, Andersson M, Rohrer S, Richards H. Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study. Arthritis Rheumatol. 2017 Jun;69(6):1144-1153. doi: 10.1002/art.40070. Epub 2017 May 3.

location_country:
Brazil
Romania
Spain
Italy
Russian Federation
Mexico
Canada
Czech Republic
Hungary
United States
France
Colombia
Germany
Bulgaria
Slovakia


primary_purpose: Diagnostic

acronym: GEMSAV

title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

lead_sponsor: Bayer

location_country:
Poland
Italy
Austria
Australia
Argentina
Switzerland
Sweden
Korea, Republic of
United States
France
China
Turkey
Germany
Czechia

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).


title: Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

summary:
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing.

The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review.

lead_sponsor: Addex Pharma S.A.

location_country:
Austria
Germany
United States
France


title: A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

acronym: OPSALIN

summary:
Primary Objective:

- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.

Secondary Objectives:

To compare the overall survival (OS) between the 2 treatment arms
To compare the objective response rate (RR) between the 2 treatment arms

lead_sponsor: Sanofi

location_country:
Poland
Spain
Italy
Russian Federation
Czech Republic
Ukraine
France
United States
Belgium
Germany

location_facility:
Investigational Site Number 250003
Investigational Site Number 056002
Investigational Site Number 643002
Investigational Site Number 840001
Investigational Site Number 203002
Investigational Site Number 643003
Investigational Site Number 616002
Investigational Site Number 380001
Investigational Site Number 616001
Investigational Site Number 840202
Investigational Site Number 380003
Investigational Site Number 804002
Investigational Site Number 250002
Investigational Site Number 056005
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 616004
Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 840009
Investigational Site Number 616005
Investigational Site Number 804003
Investigational Site Number 804005
Investigational Site Number 203004
Investigational Site Number 724001
Investigational Site Number 380004
Investigational Site Number 724003
Investigational Site Number 203001
Investigational Site Number 643001
Investigational Site Number 643004
Investigational Site Number 056001
Investigational Site Number 840002
Investigational Site Number 804004
Investigational Site Number 056003
Investigational Site Number 203003
Investigational Site Number 250004
Investigational Site Number 276001
Investigational Site Number 250001


title: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

summary: This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Canada
Puerto Rico
United States
France
Mexico
Germany


title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial

acronym: REACT

summary:
The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

ReferenceCitation: Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4.

ReferenceCitation: Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Román J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.

ReferenceCitation: Rabe KF, Calverley PMA, Martinez FJ, Fabbri LM. Effect of roflumilast in patients with severe COPD and a history of hospitalisation. Eur Respir J. 2017 Jul 5;50(1). pii: 1700158. doi: 10.1183/13993003.00158-2017. Print 2017 Jul.

ReferenceCitation: Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13.

ReferenceCitation: Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. doi: 10.2147/COPD.S31100. Epub 2012 Jun 20.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
South Africa
Belgium
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

location_facility:
Nycomed Investigational Site
Nycomed Investigational site


title: Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

acronym: BOLT

summary: This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

ReferenceCitation: Gutzmer R, Robert C, Loquai C, Schadendorf D, Squittieri N, Arntz R, Martelli S, Dummer R. Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis. BMC Cancer. 2021 Nov 19;21(1):1244. doi: 10.1186/s12885-021-08968-1.

ReferenceCitation: Lewis K, Dummer R, Farberg AS, Guminski A, Squittieri N, Migden M. Effects of Sonidegib Following Dose Reduction and Treatment Interruption in Patients with Advanced Basal Cell Carcinoma During 42-Month BOLT Trial. Dermatol Ther (Heidelb). 2021 Dec;11(6):2225-2234. doi: 10.1007/s13555-021-00619-4. Epub 2021 Oct 20.

ReferenceCitation: Lear JT, Migden MR, Lewis KD, Chang ALS, Guminski A, Gutzmer R, Dirix L, Combemale P, Stratigos A, Plummer R, Castro H, Yi T, Mone M, Zhou J, Trefzer U, Kaatz M, Loquai C, Kudchadkar R, Sellami D, Dummer R. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):372-381. doi: 10.1111/jdv.14542. Epub 2017 Nov 6.

ReferenceCitation: Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornélis F, Lear JT, Sellami D, Dummer R. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015 Jun;16(6):716-28. doi: 10.1016/S1470-2045(15)70100-2. Epub 2015 May 14.

ipd_sharing: Yes

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Greece
Italy
Australia
United Kingdom
Canada
Switzerland
Hungary
United States
France
Belgium
Germany

location_facility: University of Colorado School of Medicine UC

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr Siteman

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator

location_facility: Penn State University / Milton S. Hershey Medical Center Hershey Medical

location_facility: University of Texas MD Anderson Cancer Center MD Anderson

location_facility: University of Pittsburgh Medical Center UPMC

location_facility: H Lee Moffitt Cancer Center and Research Institute Cutaneous Onc Dept

location_facility: Hackensack University Medical Center Hackensack (SC)

location_facility: Stanford University Medical Center Stanford Univ 2

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: University of California at Los Angeles UCLA 3

location_facility: Washington Hospital Center Wash Hospital

location_facility: Texas Oncology Cancer Care & Research Center

location_facility: University of Utah / Huntsman Cancer Institute Huntsman/Univ UT

location_facility: Texoma Cancer Center Texoma Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)


title: A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

summary: The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

lead_sponsor: Fovea Pharmaceuticals SA

location_country:
Poland
Spain
Italy
Australia
Czech Republic
United States
France
Israel
Belgium
Germany

location_facility:
Center 1104
Center 1403
Center 1507
Center 1202
Center 1905
Center 1111
Center 1201
Center 1401
Center 1907
Center 1505
Center 1110
Center 1503
Center 1609
Center 1909
Center 1703
Center 1101
Center 1115
Center 1114
Center1801
Center 1405
Center 1209
Center 1205
Center 1208
Center 2002
Center 1601
Center 1705
Center 1108
Center 2004
Center 1903
Center 1103
Center 1904
Center 1606
Center 1802
Center 1204
Center 2001
Center 1607
Center 1501
Center 1106
Center 1107
Center 2003
Center 1116
Center 1902
Center 1504
Center 1206
Center 1610
Center 1105
Center 1608
Center 1906
Center 1404
Center 1604
Center 1908
Center 1901
Center 1701
Center 1506
Center 1303
Center 1702
Center 1706
Center 1502
Center 1301
Center 1704
Center 1402
Center 1302
Center 1112
Center 1109
Center 1203


title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

summary: This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

lead_sponsor: Debiopharm International SA

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Canada
Hungary
Germany
Taiwan
Thailand
Vietnam
Korea, Republic of
France


title: A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease

summary: The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

ReferenceCitation: Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.

ReferenceCitation: Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.

ReferenceCitation: Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.

ReferenceCitation: Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.

ReferenceCitation: Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1). pii: 00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.

ReferenceCitation: Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051. Erratum in: J Am Coll Cardiol. 2018 Oct 30;72(18):2282.

ReferenceCitation: Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.

ReferenceCitation: Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting β-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE.

ReferenceCitation: Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. β-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.

ReferenceCitation: Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1). pii: 1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan.

ReferenceCitation: Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.

ReferenceCitation: Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC.

ReferenceCitation: Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17.

ReferenceCitation: Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC.

ReferenceCitation: Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, Martinez F, Yates J, Newby DE; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817-26. doi: 10.1016/S0140-6736(16)30069-1. Epub 2016 Apr 28.

ReferenceCitation: Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, Haumann B, Martinez FJ, Yates J, Newby DE. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.

lead_sponsor: GlaxoSmithKline

location_country: Macedonia, The Former Yugoslav Republic of

intervention_type: Other


title: An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

summary: The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

ReferenceCitation: Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Argentina
Canada
Thailand
Hungary
United States
France
Singapore
Turkey
Belgium
Japan
Germany

location_facility: Mayo Clinic - Arizona Mayo Scottsdale AZ

location_facility: University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC

location_facility: Massachusetts General Hospital Mass General

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)

location_facility: Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

location_facility: Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: Emory University School of Medicine/Winship Cancer Institute Emory 2

location_facility: Karmanos Cancer Institute Wayne St Karmanos

location_facility: H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

location_facility: University of Chicago Medical Center Unvi Chi

location_facility: Virginia Oncology Associates VOA - Lake Wright (2)

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: University of Pittsburgh Medical Center SC-2

location_facility: Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)

location_facility: Arizona Oncology Associates Tucson (Rudasill & La Cholla)

location_facility: Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med

location_facility: Washington University School of Medicine Washington University (16)

location_facility: Memorial Sloan Kettering Cancer Center Sloan Kettering

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Medical University of South Carolina MUSC

location_facility: University of Kansas Cancer Center Univ of KS


title: A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

summary: The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

ReferenceCitation: Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hébuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Italy
Austria
Australia
Mexico
Canada
Netherlands
Hungary
United States
France
South Africa
Belgium
Germany

location_facility: Gastroenterology Research Of San Antonio

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Long Island Clinical Research Assoc., Llp

location_facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

location_facility: Gastroenterology Research Of Tyler (Gerty)

location_facility: Gastroenterology Research Of New Orleans

location_facility: University Of North Carolina At Chapel Hill


title: An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL

summary: This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnböck HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

location_country:
Croatia
Poland
Brazil
Portugal
Spain
Greece
Italy
Australia
New Zealand
Argentina
Canada
Russian Federation
France
Chile
Turkey
Mexico
Germany
Slovakia
Czechia

location_facility: City Clinical Hospital After Botkin; Hematology

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: University Hospital Center Zagreb; Haematology Department

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

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Klinikum Frankfurt; Medizinische Klinik I

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Papageorgiou General Hospital of Thessaloniki; Hematology Clinic

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Policlinico G. B. Rossi; Divisione Di Ematologia

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: University Hospital; Clinic of Hematology & Transfusiology

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

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

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Haematology Research Center; Haematology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Hematologia

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: University Hospital and Medical School; IV.Dept. of Internal Medicine and Hematology

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Clinical Hospital Merkur; Dept of Haematology

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

location_facility: Gemeinschaftspraxis Dr. Siehl & Dr. Soeling

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

location_facility: Royal Brisbane and Women'S Hospital; Haematology

location_facility: St George Hospital; Department of Haematology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

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

ReferenceCitation: Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4. Erratum in: Lancet. 2016 Apr 30;387(10030):1816.

lead_sponsor: Janssen R&D Ireland

location_country:
Poland
Brazil
Portugal
Spain
Austria
Netherlands
Argentina
Puerto Rico
United States
France
Turkey
Belgium
Germany
Bulgaria
Slovakia


title: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

summary: This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

ReferenceCitation: Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27.

lead_sponsor: Genentech, Inc.

location_country:
Netherlands
United States
Canada
France

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Cross Cancer Institute ; Dept of Medical Oncology


title: A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

lead_sponsor: Amgen

ReferenceCitation: Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.

location_country:
Denmark
Poland
Taiwan
Hong Kong
United Kingdom
Italy
Austria
Australia
New Zealand
Canada
Switzerland
Hungary
United States
France
Singapore
Belgium
Germany
Slovakia

summary:
To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.


title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.

lead_sponsor: Sandoz

ReferenceCitation: Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.

location_country:
Brazil
Romania
Spain
Italy
Austria
Estonia
Argentina
Hungary
United States
France
India
Turkey
Belgium
Germany

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.

summary: The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.


title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

ReferenceCitation: Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016 Oct;150(4):789-798. doi: 10.1016/j.chest.2016.03.032. Epub 2016 Apr 4.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
Brazil
Colombia
Mexico
Argentina
Canada
Sweden
Hungary
United States
France
Israel
Belgium
Netherlands

location_facility:
Teva Investigational Site 341
Teva Investigational Site 11
Teva Investigational Site 26
Teva Investigational Site 505
Teva Investigational Site 15
Teva Investigational Site 184
Teva Investigational Site 260
Teva Investigational Site 403
Teva Investigational Site 105
Teva Investigational Site 600
Teva Investigational Site 504
Teva Investigational Site 143
Teva Investigational Site 512
Teva Investigational Site 43
Teva Investigational Site 340
Teva Investigational Site 142
Teva Investigational Site 203
Teva Investigational Site 17
Teva Investigational Site 12
Teva Investigational Site 182
Teva Investigational Site 10
Teva Investigational Site 150
Teva Investigational Site 122
Teva Investigational Site 125
Teva Investigational Site 123
Teva Investigational Site 144
Teva Investigational Site 3
Teva Investigational Site 19
Teva Investigational Site 141
Teva Investigational Site 24
Teva Investigational Site 200
Teva Investigational Site 420
Teva Investigational Site 404
Teva Investigational Site 6
Teva Investigational Site 261
Teva Investigational Site 140
Teva Investigational Site 264
Teva Investigational Site 4
Teva Investigational Site 128
Teva Investigational Site 16
Teva Investigational Site 507
Teva Investigational Site 500
Teva Investigational Site 602
Teva Investigational Site 422
Teva Investigational Site 27
Teva Investigational Site 181
Teva Investigational Site 101
Teva Investigational Site 45
Teva Investigational Site 147
Teva Investigational Site 124
Teva Investigational Site 343
Teva Investigational Site 202
Teva Investigational Site 146
Teva Investigational Site 204
Teva Investigational Site 8
Teva Investigational Site 400
Teva Investigational Site 145
Teva Investigational Site 7
Teva Investigational Site 180
Teva Investigational Site 183
Teva Investigational Site 421
Teva Investigational Site 104
Teva Investigational Site 126
Teva Investigational Site 18
Teva Investigational Site 14
Teva Investigational Site 601
Teva Investigational Site 2
Teva Investigational Site 344
Teva Investigational Site 1
Teva Investigational Site 342
Teva Investigational Site 407
Teva Investigational Site 121
Teva Investigational Site 73
Teva Investigational Site 103
Teva Investigational Site 9
Teva Investigational Site 502
Teva Investigational Site 513
Teva Investigational Site 406
Teva Investigational Site 185
Teva Investigational Site 127
Teva Investigational Site 401
Teva Investigational Site 5
Teva Investigational Site 263
Teva Investigational Site 402
Teva Investigational Site 21
Teva Investigational Site 120
Teva Investigational Site 20
Teva Investigational Site 460
Teva Investigational Site 205