title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
Czech Republic
United States
France
Belgium
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Association of Physicians for Infection Diseases

location_facility: Hospital Clínico Universitario San Cecilio

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia

location_facility: UT Southwestern Medical Center at Dallas

location_facility: University of Miami Center for Liver Diseases

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: University Hospitals Case Medical Center

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: Emory University, Infectious Disease Clinic

location_facility: Hospital General Universitario de Valencia

location_facility: U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Hospital Universitario Ntra. Sra. de Valme

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Medicina Generale - Azienda Ospedaliera di Padova

location_facility: Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH

location_facility: Epatologia, Azienda Ospedaliero "Spedali Civili"

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista

location_facility: Ottawa Hospital, Division of Infectious Diseases

location_facility: SGS - Clinical Pharmacology Unit Antwerpen

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Institute of Clinic and Experimental Medicine

location_facility: University of Alberta, Division of Gastroenterology

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: Institute of Cellular Medicine (Hepatology)

location_facility: Cornell University Gastroenterology & Hepatology


title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

acronym: SENTIO

summary: The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Guerbet

location_country:
Brazil
Spain
Italy
Austria
United Kingdom
Argentina
Korea, Republic of
United States
Chile
France
Germany

location_facility: University of Alabama at Birmingham, UABMC

location_facility: Universidade Federal de São Paulo / UNIFESP

location_facility: Complejo Hospitalario Universitario de Vigo - Serviço de radiologia

location_facility: Gruss Magnetic resonance Research Clinic

location_facility: Hospital Clinico Universitario San Carlos

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Fédération d'Imagerie Médicale,Hôpital Pontchaillou

location_facility: University of Texas - Health Science Center

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


status: Terminated

primary_purpose: Treatment

acronym: HOMER

intervention_type: Biological

title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

lead_sponsor: Novartis Pharmaceuticals

source: euctr

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Maloney DG, Ogura M, Fukuhara N, Davis J, Lasher J, Izquierdo M, Banerjee H, Tobinai K. A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy. Blood Adv. 2020 Aug 25;4(16):3886-3893. doi: 10.1182/bloodadvances.2020001942.

location_country:
Brazil
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
China
Peru
Belgium
Japan
Puerto Rico
South Africa
Bulgaria
Slovakia
Czechia

summary:
This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen.

The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed.

Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.

status_simplified: Unknown


type: EudraCT Number

title: A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

summary: The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.

lead_sponsor: Amgen

location_country:
Poland
Spain
Australia
Canada
United States
France
Belgium
Netherlands


acronym: ARTEMIS AF LT

title: A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment.

lead_sponsor: Sanofi

ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brûlé L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

location_country:
Denmark
Spain
Mexico
Czech Republic
France
Colombia
Germany

location_facility:
Investigational Site Number 250-004
Investigational Site Number 276-001
Investigational Site Number 250-003
Investigational Site Number 484005
Investigational Site Number 203002
Investigational Site Number 208-002
Investigational Site Number 170003
Investigational Site Number 484003
Investigational Site Number 170006
Investigational Site Number 484004
Investigational Site Number 170007
Investigational Site Number 203007
Investigational Site Number 203006
Investigational Site Number 250-001
Investigational Site Number 250-005
Investigational Site Number 276-005
Investigational Site Number 208-003
Investigational Site Number 724002
Investigational Site Number 203005
Investigational Site Number 170005
Investigational Site Number 724005
Investigational Site Number 203004
Investigational Site Number 250-002
Investigational Site Number 724001
Investigational Site Number 724006
Investigational Site Number 170001
Investigational Site Number 724003
Investigational Site Number 170002
Investigational Site Number 484001
Investigational Site Number 203001
Investigational Site Number 276-002
Investigational Site Number 484002
Investigational Site Number 724004
Investigational Site Number 276-003
Investigational Site Number 484006
Investigational Site Number 203008
Investigational Site Number 203003
Investigational Site Number 250-006
Investigational Site Number 208-001
Investigational Site Number 276-004

summary:
Primary Objective:

- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

Explore potential PK interaction between Dronedarone and Amiodarone
Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety


type: Other Identifier

title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

summary: A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. doi: 10.1200/JCO.20.01894. Epub 2020 Aug 21.

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. doi: 10.1200/JCO.2017.74.7824. Epub 2017 Dec 15. Retraction in: J Clin Oncol. 2021 Jan 1;39(1):95.

ipd_sharing: Yes

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

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

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Norway
Singapore
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Korea, Republic of
France
Colombia


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease

summary: The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.


title: Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

summary: The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

location_country:
Brazil
Spain
Colombia
Ireland
Australia
Italy
Argentina
Netherlands
Russian Federation
United Kingdom
Sweden
United States
France
Belgium
Germany
Czechia


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: PE-Prove

summary: The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07.

ipd_sharing: No

ipd_sharing_description: Data are presented at the 2013 EuroPCR congress.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Hungary
France
Belgium
Germany

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen

location_facility: Centre Hospitalier Privé Saint Martin gds

location_facility: Dept. of Internal Medicine and Cardiological Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hôpital Universitaire Sart Tilman

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

intervention_type: Device


title: A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

summary: This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

primary_purpose: Prevention

ReferenceCitation: Pascher A, De Simone P, Pratschke J, Salamé E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.

location_country:
Spain
Italy
Austria
Argentina
Canada
Finland
Switzerland
United States
France
Belgium
Germany
Czechia


acronym: GRIPHON

title: A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

lead_sponsor: Actelion

ReferenceCitation: Sitbon O, Channick R, Chin KM, Frey A, Gaine S, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, Preiss R, Rubin LJ, Di Scala L, Tapson V, Adzerikho I, Liu J, Moiseeva O, Zeng X, Simonneau G, McLaughlin VV; GRIPHON Investigators. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2015 Dec 24;373(26):2522-33. doi: 10.1056/NEJMoa1503184.

ReferenceCitation: Galiè N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.

ReferenceCitation: Gaine S, Sitbon O, Channick RN, Chin KM, Sauter R, Galiè N, Hoeper MM, McLaughlin VV, Preiss R, Rubin LJ, Simonneau G, Tapson V, Ghofrani HA, Lang I. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. Chest. 2021 Jul;160(1):277-286. doi: 10.1016/j.chest.2021.01.066. Epub 2021 Feb 3.

ReferenceCitation: Chin KM, Rubin LJ, Channick R, Di Scala L, Gaine S, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin VV, Preiss R, Simonneau G, Sitbon O, Tapson VF. Association of N-Terminal Pro Brain Natriuretic Peptide and Long-Term Outcome in Patients With Pulmonary Arterial Hypertension. Circulation. 2019 May 21;139(21):2440-2450. doi: 10.1161/CIRCULATIONAHA.118.039360.

ReferenceCitation: McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galiè N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.

ReferenceCitation: Coghlan JG, Channick R, Chin K, Di Scala L, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Gaine S. Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study. Am J Cardiovasc Drugs. 2018 Feb;18(1):37-47. doi: 10.1007/s40256-017-0262-z.

ReferenceCitation: Gaine S, Chin K, Coghlan G, Channick R, Di Scala L, Galiè N, Ghofrani HA, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Hoeper MM. Selexipag for the treatment of connective tissue disease-associated pulmonary arterial hypertension. Eur Respir J. 2017 Aug 17;50(2). pii: 1602493. doi: 10.1183/13993003.02493-2016. Print 2017 Aug.

ReferenceCitation: Krause A, Machacek M, Lott D, Hurst N, Bruderer S, Dingemanse J. Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):477-485. doi: 10.1002/psp4.12202. Epub 2017 May 27.

ReferenceCitation: Skoro-Sajer N, Lang IM. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2014 Feb;15(3):429-36. doi: 10.1517/14656566.2014.876007. Epub 2014 Jan 7. Review.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Belarus
Greece
Ireland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: University of Wisconsin Hospital-Department of Medicine

location_facility: Washington University School of Medicine

location_facility: Hosp A. Beclere - Dept Pulmo & Resp Intensive Care

location_facility: Hopital General Juif (Jewish General Hospital)

location_facility: Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital

location_facility: Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: Municipal Medical Institution City Hospital #5

location_facility: Minsk Regional Clinical Hospital of the Red Banner of Labour

location_facility: St. Vincent's Hospital / Heart and Lung Transplant Unit

location_facility: Rigshospitalet, Hjertemedicinsk klinik - Cardiology

location_facility: "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"

location_facility: V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex

location_facility: Health Care Municipal Institution, City Clinical Hospital #13

location_facility: "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"

location_facility: Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases

location_facility: Umeå University Hospital, Cardiology (Umeå)

location_facility: Kantonsspital St. Gallen Klinik für Pneumologie

location_facility: Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia

location_facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

location_facility: Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F

location_facility: Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)

location_facility: "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"

location_facility: "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"

location_facility: Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Tomsk Regional Clinical Hospital/ Pulmonology Unit

location_facility: The Institution of the Clinical Cardiology named after A. L. Myaskinov

location_facility: Froedtert Hospital - Medical College of Wisconsin

location_facility: Medical University of Vienna and AKH Cardiology

location_facility: The Republican Scientific-Practical Center "Cardiology"

location_facility: University of Alberta Hospital - Children's Centre

location_facility: University Hospitals Case Medical Center

location_facility: Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai

location_facility: "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""

location_facility: "Pécsi Tudományegyetem Klinikai Központ,

location_facility: Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology

location_facility: University of California San Diego Medical Center (La Jolla)

location_facility: Johns Hopkins University School of Medicine

location_facility: Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine

location_facility: Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares

location_facility: Peking Union Medical College Hospital, Rheumatology Department

location_facility: John Hunter Hospital Autoimmune Resource and Research Centre

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: The University of Arizona, Clinical and Translational Science (CATS) Research Center

location_facility: Columbia University Medical Center, Pediatric Cardiology

location_facility: Istanbul Üniversitesi Kardiyoloji Enstitisü

location_facility: "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"

location_facility: Medizinische Hochschule Hannover / Klinik für Pneumologie

location_facility: ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia

location_facility: Sanjivani Hospitals - Department of Cardiology

location_facility: "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"

location_facility: Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare

location_facility: Pulmonology Institute, Hadassah University Hospital at Ein Karem

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.

location_facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: Montefiore Medical Center, Weiler Division

location_facility: "Semmelweis Egyetem, Pulmonológiai Klinika"

location_facility: Royal Hobart Hospital, Centre for Clinical Research

location_facility: Newark Beth Isreal Medical Center-Department of Pulmonary Medicine

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Shanghai Pulmonary Hospital, Department of Pulmonary Circulation

location_facility: Universitätsklinkum Regensburg / Innere Medizin II

location_facility: State Institution, "Institute fo Rheumatology of RAMS"

location_facility: Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine

location_facility: Kaohsiung Veterans General Hospital (KVGH)

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13

location_facility: St. Antonius Ziekenhuis afdeling Longziekten

location_facility: Universitätsspital Bern, Clinic for Pneumology (Inselspital)

location_facility: University of Texas-Houston Health Center Department of Pulmonary & Critical Care

location_facility: Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"

location_facility: Erasmus Medisch Centrum Rotterdam afdeling longziekten

location_facility: Samsung Medical Center, Division of Cardiology

location_facility: Hosp Vall D'Hebron - Barcelona - Pneumology

location_facility: Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center

location_facility: Yonsei University Health System Dept of Cardiology

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

location_facility: CARE Hospitals Nampally, Cardiology Dep. Hyderabad

location_facility: Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2

location_facility: University Hospital Basel Division of Pneumology

location_facility: The Ohio State University Medical Center

location_facility: "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"

location_facility: Massachusetts General Hospital-Pulmonary Critical Care Unit

location_facility: Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

location_facility: "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"

location_facility: Linköping University Hospital, Cardiology

location_facility: Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen

location_facility: Boston University School of Medicine / Boston University Medical Center

location_facility: Lung Health & Sleep Emhancement Center, LLC

location_facility: Universität Greifswald / Klinik für Innere Medizin B

location_facility: Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department

location_facility: HUG Hôpitaux Universitaires de Genève; Pneumology, PAH

location_facility: University of California, Davis, UC Davis Medical Center

location_facility: "Klinički Centar Srbije, Klinika za pulmologiju"

location_facility: University Hospital Gasthuisberg - Pneumologie

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez

location_facility: Limited liability company, Consultative diagnostic centre Healthy Joints

location_facility: Instituto Nacional del Torax Teaching Dept

location_facility: "The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"

location_facility: National Taiwan University Hospital / Department of Surgery

location_facility: Massachusetts General Hospital - Pulmonary Critical Care Unit

location_facility: "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"

location_facility: Prince Charles Hospital Lung Transplant, Thoracic Department

location_facility: "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"

location_facility: Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie

location_facility: Instituto de Enfermedades Respiratorias Clinica San Gabriel

location_facility: VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48

summary: The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


title: A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma

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

location_country:
Spain
United Kingdom
Austria
Finland
Switzerland
France
Belgium
Germany

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: Csu de Bellvitge (Institut Catala D'Oncologia)

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Helsinky University Central Hospital - Skin & Allergy Hospital

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

location_facility: Medical University Vienna - General Hospital

location_facility: Chu de Bordeaux - Hopital Du Haut Leveque

location_facility: Guy'S and St Thomas' Nhs - St Thomas Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

summary:
RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.


title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)

summary: The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

lead_sponsor: Eli Lilly and Company

location_country:
Greece
Italy
Australia
Russian Federation
Canada
United States
France
Germany

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


title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

lead_sponsor: UCB BIOSCIENCES GmbH

ReferenceCitation: Landewé R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.

ReferenceCitation: Baraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.

ReferenceCitation: Landewé R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.

ReferenceCitation: van der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.

ReferenceCitation: van der Heijde D, Dougados M, Landewé R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.

ReferenceCitation: van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.

ReferenceCitation: Rudwaleit M, Rosenbaum JT, Landewé R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.

ReferenceCitation: Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewé R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Mexico
Netherlands
Argentina
Canada
Hungary
United States
France
Belgium
Germany
Czechia

summary: The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).


acronym: PROSIPAL

title: A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia

lead_sponsor: Janssen-Cilag International NV

location_country:
Croatia
Spain
United Kingdom
Lithuania
Ukraine
Romania
South Africa
Belgium
Poland
Austria
Russian Federation
Israel
Turkey
Slovakia
Egypt
Hungary
Germany
Bulgaria
Taiwan
Jordan
Greece
Estonia
Czech Republic
Korea, Republic of
France

summary: The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

summary: The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

ReferenceCitation: Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1). pii: e001149. doi: 10.1136/rmdopen-2019-001149.

ReferenceCitation: Siebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

ReferenceCitation: Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.

ReferenceCitation: Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
United Kingdom
Austria
Russian Federation
Canada
Sweden
Hungary
United States
France
Germany


status: Active, not recruiting

acronym: LEPHT

title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

study_completion_date_type: Anticipated

lead_sponsor: Bayer

ReferenceCitation: Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.

ReferenceCitation: Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
United States
France
China
Singapore
Belgium
Japan
Germany
Czechia

summary: The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

status_simplified: Ongoing


title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

summary: The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

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

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13. Review.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Romania
Poland
Australia
Argentina
Puerto Rico
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Greece
Czech Republic
France
Chile
Colombia
Netherlands

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Providence Regional Medical Center Everett

location_facility: Lynn Cancer Institute Center For Hematology-Oncology

location_facility: North Shore Hematology/Oncology Associates, P.C.

location_facility: Southern California Permanente Medical Group

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Scott & White Memorial Hospital And Clinic

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Hematology Oncology Associates Of The Treasure Coast


title: Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voß F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

location_country: Austria Australia Canada France Germany

location_facility: 1222.37.33006 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4371 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4970 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33003 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6173 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33005 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6174 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4973 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33001 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4972 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4372 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33004 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6171 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33002 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4971 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1072 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6172 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1074 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1073 Boehringer Ingelheim Investigational Site

summary: To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease


type: Registry Identifier

title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

ReferenceCitation: Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.

location_country:
Spain
Ireland
Italy
United Kingdom
Argentina
United States
France
Germany

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of North Carolina, Chapel Hill

location_facility: Hospital Of The University Of Pennsylvania


intervention_type: Other

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents

lead_sponsor: Celgene

ReferenceCitation: Santini V, Almeida A, Giagounidis A, Gröpper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Cañizo C, Gattermann N, Ozawa K, Risueño A, MacBeth KJ, Zhong J, Séguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.

ReferenceCitation: Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P. Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels. Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17.

ReferenceCitation: Almeida A, Fenaux P, Garcia-Manero G, Goldberg SL, Gröpper S, Jonasova A, Vey N, Castaneda C, Zhong J, Beach CL, Santini V. Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. Leuk Lymphoma. 2018 Sep;59(9):2135-2143. doi: 10.1080/10428194.2017.1421758. Epub 2018 Jan 11.

location_country:
Poland
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
United States
France
Israel
Turkey
Belgium
Japan
Germany
Czechia

location_facility: Center Hospitalier Universitaire Ambroise Pare

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Groupe hospitalier Cochin Saint-Vincent de Paul

location_facility: Princess Margaret Hospital and University of Toronto

location_facility: P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8)

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Universitatsklinik fur Innere Medizin Salzburg

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: BAG Freiberg-Richter, Jacobash, Illmer, Wolf

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

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

location_facility: Klinikum Mannheim der Universitat Heidelberg

location_facility: Instituto Portugues de Oncologia de Lisboa

summary: The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.


title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

acronym: REACTT

summary: The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

ReferenceCitation: Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Büttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.

ReferenceCitation: Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Büttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.

ReferenceCitation: Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Büttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
France
Belgium
Germany

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


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

summary: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Finland
Puerto Rico
United States
France
Belgium


acronym: Neptune II

title: An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

lead_sponsor: Astellas Pharma Europe B.V.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Poland
Belarus
United Kingdom
Italy
Austria
Netherlands
France
Belgium
Germany
Slovakia
Czechia

summary: Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.


title: Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris

acronym: TEAM

summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

lead_sponsor: Galderma R&D

location_country: Poland Brazil Italy Australia Mexico Sweden France Belgium Germany


acronym: GALILEO

title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

ReferenceCitation: Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7. Erratum in: Br J Ophthalmol. 2015 Dec;99(12):1746.

ReferenceCitation: Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.

location_country:
Italy
Austria
Australia
Latvia
Hungary
Korea, Republic of
France
Singapore
Japan
Germany

summary: To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion


acronym: POINT

summary:
A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

ReferenceType: background

ReferenceCitation: Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18. Review.

ReferenceCitation: Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. Epub 2007 Nov 13. Review.

ReferenceCitation: Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1.

ReferenceCitation: Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4.

ReferenceCitation: Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27.

ReferenceCitation: Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400.

ReferenceCitation: Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. Epub 2007 Oct 10.

ReferenceCitation: Geisler T, Zürn C, Paterok M, Göhring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

ReferenceCitation: Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

ReferenceCitation: Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. Epub 2004 Mar 15.

ReferenceCitation: Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barillà F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

ReferenceCitation: Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. Epub 2007 Jul 10.

ReferenceCitation: Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18.

ReferenceCitation: Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Büttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.

ReferenceCitation: Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.

ReferenceCitation: Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.

ReferenceCitation: Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54.

ReferenceCitation: Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9.

ReferenceCitation: Lavallée PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Lesèche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60.

ReferenceCitation: Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.

ReferenceCitation: Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

ReferenceCitation: Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

ReferenceCitation: Brown RD Jr, Petty GW, O'Fallon WM, Wiebers DO, Whisnant JP. Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989. Stroke. 1998 Oct;29(10):2109-13.

ReferenceCitation: Kissela B, Broderick J, Woo D, Kothari R, Miller R, Khoury J, Brott T, Pancioli A, Jauch E, Gebel J, Shukla R, Alwell K, Tomsick T. Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study. Stroke. 2001 Jun;32(6):1285-90.

ReferenceCitation: Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999 Dec;30(12):2523-8.

ReferenceCitation: Kleindorfer D, Panagos P, Pancioli A, Khoury J, Kissela B, Woo D, Schneider A, Alwell K, Jauch E, Miller R, Moomaw C, Shukla R, Broderick JP. Incidence and short-term prognosis of transient ischemic attack in a population-based study. Stroke. 2005 Apr;36(4):720-3. Epub 2005 Feb 24.

ReferenceCitation: Edlow JA, Kim S, Pelletier AJ, Camargo CA Jr. National study on emergency department visits for transient ischemic attack, 1992-2001. Acad Emerg Med. 2006 Jun;13(6):666-72. Epub 2006 Apr 11.

ReferenceCitation: Howard G, Toole JF, Frye-Pierson J, Hinshelwood LC. Factors influencing the survival of 451 transient ischemic attack patients. Stroke. 1987 May-Jun;18(3):552-7.

ReferenceCitation: Shah KH, Kleckner K, Edlow JA. Short-term prognosis of stroke among patients diagnosed in the emergency department with a transient ischemic attack. Ann Emerg Med. 2008 Mar;51(3):316-23. doi: 10.1016/j.annemergmed.2007.08.016. Epub 2007 Oct 25. Review. Erratum in: Ann Emerg Med. 2008 Jun;51(6):774.

ReferenceCitation: Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. Review.

ReferenceCitation: Gladstone DJ, Kapral MK, Fang J, Laupacis A, Tu JV. Management and outcomes of transient ischemic attacks in Ontario. CMAJ. 2004 Mar 30;170(7):1099-104.

ReferenceCitation: Lisabeth LD, Ireland JK, Risser JM, Brown DL, Smith MA, Garcia NM, Morgenstern LB. Stroke risk after transient ischemic attack in a population-based setting. Stroke. 2004 Aug;35(8):1842-6. Epub 2004 Jun 10.

ReferenceCitation: Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9.

ReferenceCitation: Hill MD, Yiannakoulias N, Jeerakathil T, Tu JV, Svenson LW, Schopflocher DP. The high risk of stroke immediately after transient ischemic attack: a population-based study. Neurology. 2004 Jun 8;62(11):2015-20.

ReferenceCitation: Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36.

ReferenceCitation: Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. Epub 2003 Jul 10.

ReferenceCitation: Rao SV, Ohman EM, Granger CB, Armstrong PW, Gibler WB, Christenson RH, Hasselblad V, Stebbins A, McNulty S, Newby LK. Prognostic value of isolated troponin elevation across the spectrum of chest pain syndromes. Am J Cardiol. 2003 Apr 15;91(8):936-40.

ReferenceCitation: Whisnant JP, Matsumoto N, Elveback LR. Transient cerebral ischemic attacks in a community. Rochester, Minnesota, 1955 through 1969. Mayo Clin Proc. 1973 Mar;48(3):194-8.

ReferenceCitation: Humphrey PR, Marshall J. Transient ischemic attacks and strokes with recovery prognosis and investigation. Stroke. 1981 Nov-Dec;12(6):765-9.

ReferenceCitation: Putman SF, Adams HP Jr. Usefulness of heparin in initial management of patients with recent transient ischemic attacks. Arch Neurol. 1985 Oct;42(10):960-2.

ReferenceCitation: Biller J, Bruno A, Adams HP Jr, Godersky JC, Loftus CM, Mitchell VL, Banwart KJ, Jones MP. A randomized trial of aspirin or heparin in hospitalized patients with recent transient ischemic attacks. A pilot study. Stroke. 1989 Apr;20(4):441-7.

ReferenceCitation: Dennis M, Bamford J, Sandercock P, Warlow C. Prognosis of transient ischemic attacks in the Oxfordshire Community Stroke Project. Stroke. 1990 Jun;21(6):848-53.

ReferenceCitation: Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. Epub 2004 Jan 26.

ReferenceCitation: Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. Epub 2004 Oct 14.

ReferenceCitation: Whitehead MA, McManus J, McAlpine C, Langhorne P. Early recurrence of cerebrovascular events after transient ischaemic attack. Stroke. 2005 Jan;36(1):1; author reply 1.

ReferenceCitation: Correia M, Silva MR, Magalhães R, Guimarães L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. Epub 2005 Dec 1.

ReferenceCitation: Purroy F, Molina CA, Montaner J, Alvarez-Sabín J. Absence of usefulness of ABCD score in the early risk of stroke of transient ischemic attack patients. Stroke. 2007 Mar;38(3):855-6; author reply 857. Epub 2007 Jan 18.

ReferenceCitation: Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

ReferenceCitation: Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

ReferenceCitation: Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10. Review.

ReferenceCitation: Mac Grory B, Piccini JP, Yaghi S, Poli S, De Havenon A, Rostanski SK, Weiss M, Xian Y, Johnston SC, Feng W. Hyperglycemia, Risk of Subsequent Stroke, and Efficacy of Dual Antiplatelet Therapy: A Post Hoc Analysis of the POINT Trial. J Am Heart Assoc. 2022 Feb;11(3):e023223. doi: 10.1161/JAHA.121.023223. Epub 2022 Jan 19.

ReferenceCitation: Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.

ReferenceCitation: Kamel H, Zhang C, Kleindorfer DO, Levitan EB, Howard VJ, Howard G, Soliman EZ, Johnston SC. Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):601-605. doi: 10.1001/jamaneurol.2020.0010.

ReferenceCitation: Cucchiara B, Elm J, Easton JD, Coutts SB, Willey JZ, Biros MH, Ross MA, Johnston SC. Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial. Stroke. 2020 Mar;51(3):792-799. doi: 10.1161/STROKEAHA.119.027465. Epub 2020 Feb 12.

ReferenceCitation: Farrant M, Easton JD, Adelman EE, Cucchiara BL, Barsan WG, Tillman HJ, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Zhao W, Pauls K, Walsh KB, Martí-Fàbregas J, Bernstein RA, Johnston SC. Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis. JAMA Netw Open. 2019 Sep 4;2(9):e1910769. doi: 10.1001/jamanetworkopen.2019.10769.

ReferenceCitation: Johnston SC, Elm JJ, Easton JD, Farrant M, Barsan WG, Kim AS, Lindblad AS, Palesch YY, Zurita KG, Albers GW, Cucchiara BL, Kleindorfer DO, Lutsep HL, Pearson C, Sethi P, Vora N; POINT and Neurological Emergencies Treatment Trials Network Investigators. Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke. Circulation. 2019 Aug 20;140(8):658-664. doi: 10.1161/CIRCULATIONAHA.119.040713. Epub 2019 Jun 26.

ReferenceCitation: Tillman H, Johnston SC, Farrant M, Barsan W, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Easton JD. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):774-782. doi: 10.1001/jamaneurol.2019.0932.

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

ReferenceCitation: Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.

lead_sponsor: University of California, San Francisco

location_country:
Spain
United Kingdom
Australia
New Zealand
Finland
Canada
United States
France
Mexico
Germany

location_facility: Mexican Association for Clinical Research

location_facility: Valley Baptist Medical Center - Harlingen

location_facility: Henrico Doctors' Hospital - Forest Campus

location_facility: Oregon Health and Science University Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Banner University Medical Center - Tucson Campus

location_facility: Henrico Doctors' Hospital - Parham Campus

location_facility: Hospital of the University of Pennsylvania

location_facility: Lincoln Medical and Mental Health Center

location_facility: Adolphe de Rothschild Ophthalmologic Foundation

location_facility: University of Texas Health Science Center San Antonio

location_facility: Pennsylvania State Hershey Medical Center

location_facility: UCSD Medical Center - Hillcrest Hospital

location_facility: Southern Illinois University Memorial Medical Center

location_facility: University of Minnesota Medical Center Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: New York Presbyterian / Columbia University Medical Center

location_facility: Great Falls Clinic Hospital, Great Falls

location_facility: University Hospital Schleswig-Holstein Kiel Campus

location_facility: University of Calgary - Foothills Campus

location_facility: Central Hospital Dr. Ignacio Morones Prieto

location_facility: Medical University of South Carolina University Hospital

location_facility: Texas Health Presbyterian Hospital - Dallas

lead_sponsor_type: academique


title: A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis

ReferenceCitation: Malattia C, Ruperto N, Pederzoli S, Palmisani E, Pistorio A, Wouters C, Dolezalova P, Flato B, Garay S, Giancane G, Wells C, Douglass W, Brunner HI, De Benedetti F, Ravelli A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Tocilizumab may slow radiographic progression in patients with systemic or polyarticular-course juvenile idiopathic arthritis: post hoc radiographic analysis from two randomized controlled trials. Arthritis Res Ther. 2020 Sep 10;22(1):211. doi: 10.1186/s13075-020-02303-y.

ReferenceCitation: Pardeo M, Wang J, Ruperto N, Alexeeva E, Chasnyk V, Schneider R, Horneff G, Huppertz HI, Minden K, Onel K, Zemel L, Martin A, Koné-Paut I, Siamopoulou-Mavridou A, Silva CA, Porter-Brown B, Bharucha KN, Brunner HI, De Benedetti F; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. J Rheumatol. 2019 Sep;46(9):1117-1126. doi: 10.3899/jrheum.180795. Epub 2019 Mar 1.

ReferenceCitation: Brunner HI, Ruperto N, Zuber Z, Keane C, Harari O, Kenwright A, Lu P, Cuttica R, Keltsev V, Xavier RM, Calvo I, Nikishina I, Rubio-Pérez N, Alexeeva E, Chasnyk V, Horneff G, Opoka-Winiarska V, Quartier P, Silva CA, Silverman E, Spindler A, Baildam E, Gámir ML, Martin A, Rietschel C, Siri D, Smolewska E, Lovell D, Martini A, De Benedetti F; Paediatric Rheumatology International Trials Organisation PRINTO; Pediatric Rheumatology Collaborative Study Group (PRCSG). Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann Rheum Dis. 2015 Jun;74(6):1110-7. doi: 10.1136/annrheumdis-2014-205351. Epub 2014 May 16.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
United Kingdom
United States
France
Peru
Belgium
Germany

location_facility: Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia

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

location_facility: Samara Regional Clinical Cardiology Dispensary

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°

location_facility: Clinica San Borja; Servicio De Reumatologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Royal Children'S Hospital; Paediatric Rheumatology

location_facility: SI Sceintific children health center RAMS

location_facility: Dzieciecy Szpital Kliniczny IM. Prof. A. Gebali; Oddzial Pediatrii Chorob Pluc I Reumatologii

location_facility: Royal Liverpool Childrens Hospital; Rheumatology

location_facility: British Columbia Children's Hospital; Rheumatology

location_facility: Hopitaux De Brabois; Medecine Infantile II

location_facility: I. M. Sechenov Moscow State Medical University; The Ministry of Health and Social Development of RF

location_facility: Hackensack University Medical Center; Pediatric Rheumatology

location_facility: Children's National Medical Center; Pediatric Rheumatology

location_facility: Centrum Pediatrii im Jana Pawla II; Oddzial Reumatologiczny

location_facility: Princess Margaret Children'S Hospital; Department of Immunology

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Great Ormond Street Hospital for Sick Children; Institute of Child Health

location_facility: Hospital Universitario Pedro Ernesto; Nucleo de Estudos da Saude do Adolescente

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Hospital Universitario Virgen Macarena; Servicio de Reumatologia

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Saint-Petersburg State; Pediatrics Medical Academy

location_facility: Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

location_facility: Clinica San Felipe; Consultorio de Reumatología

location_facility: ASST CENTRO SPECIALISTICO ORTOPEDICO TRAUMATO-LOGICO GAETANO PINI/CTO; Reumatol. Pediatrica

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy Sw Ludwika; Oddzial Dzieci Starszych

location_facility: Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci

location_facility: Westmead Hospital; Paediatric Rheumatology

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: Klinik Bremen-Mitte; Prof. Hess-Kinderklinik

location_facility: Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie

location_facility: Hôpital Pellegrin; Urgences Pédiatriques

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: Clementine Hospital; Kinder- und Jugendrheumatologie

location_facility: Connecticut Children's Medical Center; 5E Clinical Trials Unit

location_facility: Southern District Medical Center of Roszdrav

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: Wojewodzki Szpital Dzieciecy Im. J. Brudzinskiego

location_facility: The University of Chicago;Department of Pediatrics

summary: This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.


title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

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

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Czechia
Poland
Austria
Russian Federation
Israel
Turkey
Sweden
Canada
Hungary
Germany
Bulgaria
Georgia
Estonia
France
Netherlands

location_facility:
Teva Investigational Site 3240
Teva Investigational Site 1088
Teva Investigational Site 3140
Teva Investigational Site 3146
Teva Investigational Site 3133
Teva Investigational Site 5704
Teva Investigational Site 3137
Teva Investigational Site 3139
Teva Investigational Site 1076
Teva Investigational Site 5316
Teva Investigational Site 5026
Teva Investigational Site 1073
Teva Investigational Site 3251
Teva Investigational Site 1131
Teva Investigational Site 5029
Teva Investigational Site 1081
Teva Investigational Site 5705
Teva Investigational Site 5027
Teva Investigational Site 3242
Teva Investigational Site 5504
Teva Investigational Site 5315
Teva Investigational Site 1090
Teva Investigational Site 1075
Teva Investigational Site 5802
Teva Investigational Site 5208
Teva Investigational Site 5210
Teva Investigational Site 4204
Teva Investigational Site 3422
Teva Investigational Site 5318
Teva Investigational Site 1128
Teva Investigational Site 1130
Teva Investigational Site 3809
Teva Investigational Site 3239
Teva Investigational Site 5322
Teva Investigational Site 4206
Teva Investigational Site 5116
Teva Investigational Site 3247
Teva Investigational Site 1083
Teva Investigational Site 5021
Teva Investigational Site 1098
Teva Investigational Site 3144
Teva Investigational Site 5211
Teva Investigational Site 1092
Teva Investigational Site 5804
Teva Investigational Site 3039
Teva Investigational Site 3243
Teva Investigational Site 1093
Teva Investigational Site 5505
Teva Investigational Site 8030
Teva Investigational Site 1086
Teva Investigational Site 5114
Teva Investigational Site 5900
Teva Investigational Site 5902
Teva Investigational Site 3245
Teva Investigational Site 3810
Teva Investigational Site 1100
Teva Investigational Site 1129
Teva Investigational Site 8100
Teva Investigational Site 1085
Teva Investigational Site 3244
Teva Investigational Site 1102
Teva Investigational Site 6100
Teva Investigational Site 3246
Teva Investigational Site 5115
Teva Investigational Site 3044
Teva Investigational Site 5320
Teva Investigational Site 5022
Teva Investigational Site 3524
Teva Investigational Site 5325
Teva Investigational Site 8033
Teva Investigational Site 3525
Teva Investigational Site 3138
Teva Investigational Site 5904
Teva Investigational Site 3303
Teva Investigational Site 3238
Teva Investigational Site 3046
Teva Investigational Site 5903
Teva Investigational Site 3135
Teva Investigational Site 5317
Teva Investigational Site 1126
Teva Investigational Site 3250
Teva Investigational Site 3040
Teva Investigational Site 3038
Teva Investigational Site 3424
Teva Investigational Site 3237
Teva Investigational Site 5416
Teva Investigational Site 8101
Teva Investigational Site 1082
Teva Investigational Site 3248
Teva Investigational Site 5800
Teva Investigational Site 1096
Teva Investigational Site 3300
Teva Investigational Site 3236
Teva Investigational Site 8032
Teva Investigational Site 5801
Teva Investigational Site 3045
Teva Investigational Site 3132
Teva Investigational Site 1097
Teva Investigational Site 1084
Teva Investigational Site 5024
Teva Investigational Site 1101
Teva Investigational Site 3241
Teva Investigational Site 555
Teva Investigational Site 5030
Teva Investigational Site 6102
Teva Investigational Site 1132
Teva Investigational Site 3528
Teva Investigational Site 5212
Teva Investigational Site 3142
Teva Investigational Site 3143
Teva Investigational Site 5417
Teva Investigational Site 5023
Teva Investigational Site 5209
Teva Investigational Site 8031
Teva Investigational Site 3527
Teva Investigational Site 3526
Teva Investigational Site 3134
Teva Investigational Site 5117
Teva Investigational Site 3041
Teva Investigational Site 5319
Teva Investigational Site 5803
Teva Investigational Site 4205
Teva Investigational Site 3136
Teva Investigational Site 3529
Teva Investigational Site 5028
Teva Investigational Site 5905
Teva Investigational Site 8201
Teva Investigational Site 3302
Teva Investigational Site 5901
Teva Investigational Site 3042
Teva Investigational Site 1134
Teva Investigational Site 5025
Teva Investigational Site 3425
Teva Investigational Site 3249
Teva Investigational Site 1078

summary: The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.


title: Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

ReferenceCitation: Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Böcher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon α-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.

location_country:
Austria
Canada
United States
France
Romania
Germany

location_facility: 1220.40.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.006 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.007 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.005 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3302A Boehringer Ingelheim Investigational Site

summary: To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Büttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

ReferenceCitation: Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.

ReferenceCitation: Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.

location_country: Poland Greece Austria Australia Italy Mexico Netherlands France Belgium Germany

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