acronym: SERAPHIN OL

title: Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

lead_sponsor: Actelion

ReferenceCitation: Souza R, Delcroix M, Galié N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.

ReferenceCitation: Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.

location_country:
Croatia
Serbia
United Kingdom
Italy
Ukraine
United States
Peru
Belgium
Romania
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Malaysia
Singapore
Sweden
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Belarus
Finland
Thailand
France
Chile
Colombia
Netherlands

location_facility: University of Texas Houston Health Center

location_facility: University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)

location_facility: Washington University School of Medicine

location_facility: Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology

location_facility: Harper Univ. Hospital/ Wayne State University

location_facility: III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

location_facility: University of Florida - Division of Pulmonology

location_facility: Universitatsklinikum Regensburg/Innere Medizin II

location_facility: Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

location_facility: Universität Greifswald / Klinik für Innere Medizin B,

location_facility: National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

location_facility: Municipal Health Care Institution Kemerovo Cardiology Dispensary

location_facility: University of Texas Medical Center - St. Paul University

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Rabin Medical Center - Belinson campus - Pulmonary Institute

location_facility: Hospital Alberto Sabogal Sologuren - EsSALUD

location_facility: The pulmonary institute Sheba Medical centre

location_facility: Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology

location_facility: University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

location_facility: Jiangsu Province Hospital - Pneumology Department

location_facility: Peking Union Medical College Hospital, Rheumatology Department

location_facility: Odessa State Medical University, Military-medical Clinical Center of the South region

location_facility: Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: Hopital Arnaud de Villeneuve Service des Maladies Respiratoires

location_facility: Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

location_facility: Louisiana State University Health Sciences Center

location_facility: Netcare Milpark Hospital,Center for Chest Disease

location_facility: Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology

location_facility: Zhongshan Hospital Fudan University, Cardiology Department

location_facility: Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

location_facility: P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

location_facility: Ohio State University, Div. of Pul. & Critical Care

location_facility: Hopital Haut-Leveque-Maison du Haut-Leveque

location_facility: Republican reserach - Pratical Centre of Cardiology

location_facility: Medizinische Hochschule Hannover / Klinik für Pneumologie

location_facility: Life Care Institute of Medical Science & Research, Ahmedabad

location_facility: Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

location_facility: Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

location_facility: National University Hospital/ The Heart Institute

location_facility: Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

location_facility: Institutul de boli cardiovasculare / Clinica de Cardiologie

location_facility: Sentara Hospitals T/A Sentara Cardiovascular Research Intitute

location_facility: Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Unfallkrankenhaus Berlin, Klinik für Innere Medizin

location_facility: Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

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

location_facility: Instituto Nacional de Cardiología (INC) Ignacio Chávez

location_facility: Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

location_facility: "Semmelweis Egyetem, Pulmonológiai Klinika"

location_facility: Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

location_facility: Hospital Italiano - Garibaldi de Rosario

location_facility: Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

location_facility: Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

location_facility: University of NJ - Robert Wood Johnson Medical School

location_facility: Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

location_facility: State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"

location_facility: University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis

location_facility: VU Medisch Centrum, Dept. Pulmonology 4A 48

location_facility: Chris Hani Baragwanath Hospital, Department of Cardiology

location_facility: Pulmonary/Critical Care Division/Tufts New England Medical Center

location_facility: IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia

location_facility: Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology

location_facility: Baylor College of Medicine and the Methodist Hospital,

location_facility: Shanghai Pulmonary Hospital Department of Pulmonary Circulation

location_facility: University of Colorado CARDIAC AND VASCULAR CENTER

location_facility: University of Maryland School of Medicine; Division of Cardiology

location_facility: Columbia University Medical Center - Pediatric Cardiology

location_facility: G B Pant Hospital & Maulana Azad Medical College

location_facility: Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

location_facility: Tomsk Regional Clinical Hospital / Pulmonology Unit

location_facility: University of Cincinnati Ohio Heart Health Center

location_facility: Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology

location_facility: State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development

location_facility: State Educational Institution of High Professional Education "St Petersburg State Medical

location_facility: Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

location_facility: Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department

location_facility: Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology

location_facility: Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)

location_facility: Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr

location_facility: University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center

location_facility: Hosp Bicetre - Dept Pulmo & Resp Intensive Care

location_facility: University of Iowa, Pulmonary Hypertension Program

location_facility: National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci

location_facility: Pulmonary Institute, Kaplan Medical Center

location_facility: Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie

location_facility: Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie

location_facility: State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch

location_facility: Unidad de Investigación Clinica en Medicina

location_facility: Danylo Galytskyi Lviv State Medical University

location_facility: University Hospital of Lund, Dept. of Cardiology

location_facility: Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

summary: The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

acronym: SERAPHIN

summary: The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Pulido T, Adzerikho I, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Jing ZC, Le Brun FO, Mehta S, Mittelholzer CM, Perchenet L, Sastry BK, Sitbon O, Souza R, Torbicki A, Zeng X, Rubin LJ, Simonneau G; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013 Aug 29;369(9):809-18. doi: 10.1056/NEJMoa1213917.

ReferenceType: derived

ReferenceCitation: Di Scala L, Bacchi M, Bayer B, Turricchia S. Adjusting Overall Survival Estimates of Macitentan in Pulmonary Arterial Hypertension After Treatment Switching: Results from the SERAPHIN Study. Adv Ther. 2022 Sep;39(9):4346-4358. doi: 10.1007/s12325-022-02253-8. Epub 2022 Aug 1.

ReferenceCitation: Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.

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: Jansa P, Pulido T. Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial. Am J Cardiovasc Drugs. 2018 Feb;18(1):1-11. doi: 10.1007/s40256-017-0260-1. Review.

ReferenceCitation: Mehta S, Sastry BKS, Souza R, Torbicki A, Ghofrani HA, Channick RN, Delcroix M, Pulido T, Simonneau G, Wlodarczyk J, Rubin LJ, Jansa P, Hunsche E, Galiè N, Perchenet L, Sitbon O. Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial. Chest. 2017 Jan;151(1):106-118. doi: 10.1016/j.chest.2016.08.1473. Epub 2016 Sep 23. Erratum in: Chest. 2018 May;153(5):1287.

ReferenceCitation: Simonneau G, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ. Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN. Eur Respir J. 2015 Dec;46(6):1711-20. doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.

ReferenceCitation: Channick RN, Delcroix M, Ghofrani HA, Hunsche E, Jansa P, Le Brun FO, Mehta S, Pulido T, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Galiè N. Effect of macitentan on hospitalizations: results from the SERAPHIN trial. JACC Heart Fail. 2015 Jan;3(1):1-8. doi: 10.1016/j.jchf.2014.07.013. Epub 2014 Nov 11.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Romania
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Belarus
Thailand
France
Chile
Colombia
Netherlands

location_facility: Washington University School of Medicine

location_facility: Sentara Hospital T/A Sentara Cardiovascular Research Institute

location_facility: Zemun Clinical Hospital (Kliničko-bolnički centar "Zemun" ) / Department of Cardiology

location_facility: III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

location_facility: Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

location_facility: University Hospital Gasthuisberg / Kliniekhoofd, Interne Geneeskunde - I.G. Pneumologie

location_facility: Unidad de Investigación Clinica en Medicina, SC

location_facility: Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

location_facility: Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires

location_facility: Specialized Hospital for Active Treatment of Cardio-Vascular Diseases / Department of Pediatric Cardiology

location_facility: Universität Greifswald / Klinik für Innere Medizin B,

location_facility: Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií), Department of Cardiology and Angiology

location_facility: University Hospital in Lund, Heart and Lung Division

location_facility: National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

location_facility: Siriraj Hospital/ Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: University of Texas Medical Center - St. Paul University

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Rabin Medical Center - Belinson campus - Pulmonary Institute

location_facility: Hospital Alberto Sabogal Sologuren - EsSALUD

location_facility: The pulmonary institute Sheba Medical centre

location_facility: Municipal Health Care Institution "Kemerovo Cardiology Dispensary"

location_facility: Republican reserach - Pratical Centre of Cardilogy

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

location_facility: Jiangsu Province Hospital - Pneumology Department

location_facility: Zhongshan Hospital Fudan University, Cardiology Dept

location_facility: Medical Center of Louisiana at New Orleans

location_facility: Klinika Chorób Wewnętrznych Klatki Piersiowej

location_facility: 'Pontificia Universidad Catolica de Chile

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

location_facility: Hospital Clínico Virgen de la Victoria / Pneumology Unit,

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Netcare Milpark Hospital,Center for Chest Disease

location_facility: Hospital Clínico I Provincial, Servicio de Neumología.

location_facility: Chinese PLA General Hospital (301 Hospital), Cardiology Department

location_facility: Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

location_facility: P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

location_facility: Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med.

location_facility: Hopital Haut-Leveque - Maison du Haut-Leveque

location_facility: Life Care Institute of Medical Science & Research, Ahmedabad

location_facility: Baylor College of Medicine and the Methodist Hospital

location_facility: Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

location_facility: Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

location_facility: National University Hospital/ The Heart Institute

location_facility: Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

location_facility: Institutul de boli cardiovasculare / Clinica de Cardiologie

location_facility: Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

location_facility: University of Colorado Health Sciences Center

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Unfallkrankenhaus Berlin, Klinik für Innere Medizin

location_facility: Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

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

location_facility: Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

location_facility: University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Center, Faculty of General Medicine, II. Internal Medicine Clinic, Cardiology Center

location_facility: King Edward VII Memorial Hospital (KEM) Hospital

location_facility: Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

location_facility: University of Maryland School of Medicine

location_facility: Danylo Halytskyi Lviv State Medical University

location_facility: Hospital Juan Canalejo Servicio de Neumología

location_facility: Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

location_facility: Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

location_facility: University of NJ - Robert Wood Johnson Medical School

location_facility: Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

location_facility: University Clinical Center of Serbia / Institute for Lung Diseases and Tuberculosis

location_facility: State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"

location_facility: Klinikum der Johannes Gutenberg-Universität / II. Medizinische Klinik und Poliklinik

location_facility: Taichung Veterans General Hospital / Division of Allergy, Immunology and Rheumatology

location_facility: National Institute of Cardiovascular Diseases (Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH) / Department of Heart Transplantation

location_facility: Chris Hani Baragwanath Hospital, Department of Cardiology

location_facility: Pulmonary/Critical Care Division/Tufts New England Medical Center

location_facility: State Educational Institution of High Professional Education

location_facility: Chiang Mai Hospital / Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chiang Mai University

location_facility: Hospital Universitario Vall d'Hebron, Pneumology Unit, Planta Baja Hospital General

location_facility: Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology

location_facility: Dept. of Pulmonary Medicine - Latter Day Saints Hospital

location_facility: Hospital 12 Octubre/ Cardiology department Planta 5a.

location_facility: Istanbul University Cardiology Institure

location_facility: IInstituto de Enfermedades Respiratorias, Clinica San Gabriel

location_facility: London Health Sciences Centre / Victoria Hospital

location_facility: Hôpital Antoine Béclère / Service de Pneumologie

location_facility: Columbia University Medical Center - Pediatric Cardiology

location_facility: G B Pant Hospital & Maulana Azad Medical College

location_facility: Universitätsklinikum Regensburg / Innere Medizin II

location_facility: Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

location_facility: Tomsk Regional Clinical Hospital / Pulmonology Unit

location_facility: University of Cincinnati Ohio Heart Health Center

location_facility: Peking Union Medcical College Hospital, Rheumatology Department

location_facility: Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

location_facility: Queen Mary Hospital / Division of Cardiology, Department of Medicine

location_facility: 'Hospital Italiano - Garibaldi de Rosario

location_facility: Hospital Montecelo, Servicio de Neumología

location_facility: 'Instituto Nacional de Cardiología (INC) Ignacio Chávez

location_facility: University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA)

location_facility: Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar

location_facility: Semmelweis University, Pulmonolgy Clinic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: Not applicable

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

lead_sponsor: Eisai Inc.

type: EudraCT Number

source: euctr

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

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

summary: The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).


title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate

summary: This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

status: Terminated

lead_sponsor: Pfizer

location_country:
Romania
Serbia
Mexico
Netherlands
Canada
Hungary
United States
France
Belgium
Germany

status_simplified: Unknown


title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169

summary: To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease

design_allocation: Non-Randomized

ReferenceCitation: Makumi CW, Asgharian A, Ellis J, Shaikh S, Jimenez T, VanMeter S. Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Int J Neurosci. 2016;126(1):30-8. doi: 10.3109/00207454.2014.991924. Epub 2014 Dec 27.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
United Kingdom
Czech Republic
Hungary
France
United States
Belgium


title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

acronym: BUILD OL

summary: This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

location_country:
Spain
Ireland
Italy
Australia
United Kingdom
Canada
Czech Republic
Switzerland
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility: St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine

location_facility: Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases

location_facility: Pulmoary and Critical Care Medicine-Stanford University Medical Center

location_facility: Prince Charles Hospital- Lung Transplant, Thoraic Dept.

location_facility: Toronto General Hospital-Rosedale Medical Center PFT Lab

location_facility: Kanagawa Cardiovascular Respiratory Center

location_facility: Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen

location_facility: University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program

location_facility: Inselspital Bern-Div of Pulmonary Medicine

location_facility: SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern

location_facility: Sheba Medical Centre-Pulmonology Institute

location_facility: Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento

location_facility: University of Pennsylvania Medical Center

location_facility: Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery

location_facility: The Health Care Corporation of St. John's-Eastern Health

location_facility: Institut de Cardiologie et de Pneumologie de l'Universite Laval

location_facility: National Jewish Medical & Research Center

location_facility: Hospital Clinic Barcelona (Pneumology Service)

location_facility: University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit

location_facility: Klinik Donaustauf-Zentrum für Pneumologie

location_facility: UCLA- Division of Pulmonary & Critcal Care

location_facility: University Hospital Basel-Div of Pneumology

location_facility: Walter C. Mackenzie Health Sciences Centre-University of Alberta

location_facility: Hadassah medical Centrte: Ein Karem-Institue of Pulmonology

location_facility: Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin


title: An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy

summary:
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study. The primary objective of this extension study was to collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also known as Hunter Syndrome, from the Phase 2/Phase 3 Study TKT024. All patients enrolling into this study received weekly active treatment with idursulfase, the primary dosing regimen investigated in Study TKT024.

Hunter Syndrome is an X-linked recessive lysosomal storage disease caused by a deficiency of iduronate-2-sulfatase, an enzyme required to catabolize glycosaminoglycans (GAGS) in cells. As a result, GAGs accumulate in the lysosomes leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction. Hunter Syndrome is a rare disease with an estimated incidence of 1 in 162,000 live births.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Muenzer J, Gucsavas-Calikoglu M, McCandless SE, Schuetz TJ, Kimura A. A phase I/II clinical trial of enzyme replacement therapy in mucopolysaccharidosis II (Hunter syndrome). Mol Genet Metab. 2007 Mar;90(3):329-37. Epub 2006 Dec 20.

ReferenceCitation: Muenzer J, Wraith JE, Beck M, Giugliani R, Harmatz P, Eng CM, Vellodi A, Martin R, Ramaswami U, Gucsavas-Calikoglu M, Vijayaraghavan S, Wendt S, Puga AC, Ulbrich B, Shinawi M, Cleary M, Piper D, Conway AM, Kimura A. A phase II/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II (Hunter syndrome). Genet Med. 2006 Aug;8(8):465-73. Erratum in: Genet Med. 2006 Sep;8(9):599. Wendt, Suzanne [corrected to Wendt, Susanne]; Puga, Antonio [corrected to Puga, Ana Cristina]; Conway, Ann Marie [corrected to Conway, Anne Marie].

ReferenceCitation: Muenzer J, Beck M, Eng CM, Giugliani R, Harmatz P, Martin R, Ramaswami U, Vellodi A, Wraith JE, Cleary M, Gucsavas-Calikoglu M, Puga AC, Shinawi M, Ulbrich B, Vijayaraghavan S, Wendt S, Conway AM, Rossi A, Whiteman DA, Kimura A. Long-term, open-labeled extension study of idursulfase in the treatment of Hunter syndrome. Genet Med. 2011 Feb;13(2):95-101. doi: 10.1097/GIM.0b013e3181fea459. Erratum in: Genet Med. 2013 Oct;15(10):849.

ReferenceCitation: Beusterien KM, Yeung JE, Pang F, Brazier J. Development of the multi-attribute Adolescent Health Utility Measure (AHUM). Health Qual Life Outcomes. 2012 Aug 28;10:102.

lead_sponsor: Shire

location_country:
Brazil
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Romania
Germany

location_facility: University of Montreal / Hopital Ste-Justine

location_facility: University of North Carolina at Chapel Hill

location_facility: Mid-Illinois Hematology and Oncology Associates

location_facility: Hospital Universitario da Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul

location_facility: University of Iowa Hospitals and Clinics

location_facility: Baylor College of Medicine Texas Children's Hospital

location_facility: UNIFESP Instituto de Oncologia Pediatrica

location_facility: The Hospital for Sick Children Research Institute

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Saint Louis University Cardinal Glennon Children's Hospital

location_facility: Universita Milano Bicocca / Ospedale S. Gerardo

location_facility: Instituto da Crianca / Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Fundacao Universidade de Ciencias da Saude de Alagoas Governador Lamenha Filho / UNCISAL

location_facility: Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica

location_facility: Great Ormond Street Hospital for Sick Children

location_facility: University Hospital Germans Trias i Pujol

location_facility: Pediatric Clinical Research Center, Children's Hospital Oakland

location_facility: Upstate Medical University, State University of New York (SUNY)

location_facility: Instituto de Puericultura e Pediatria Martagao Gesteira / Hospital Pediatrico

intervention_type: Biological


title: Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing

summary: The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

primary_purpose: Diagnostic

ReferenceCitation: Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20.

ipd_sharing: No

lead_sponsor: Mallinckrodt

location_country:
United Kingdom
Spain
United States
France
Netherlands

location_facility: Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre

location_facility: Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón

location_facility: The Medical University of South Carolina

location_facility: Southampton University Hospitals Trust - Wessex Cardiothoracic Centre

location_facility: Lucile Salter Packard Children's Hospital at Stanford

location_facility: Beatrix Children's Hospital / University Hospital Groningen


title: A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Denmark
Spain
Greece
Austria
Italy
United Kingdom
Canada
Finland
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility:
Site Reference ID/Investigator# 8392
Site Reference ID/Investigator# 16749
Site Reference ID/Investigator# 7684
Site Reference ID/Investigator# 10962
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Site Reference ID/Investigator# 7522
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Site Reference ID/Investigator# 15422
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Site Reference ID/Investigator# 17193
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Site Reference ID/Investigator# 9743
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Site Reference ID/Investigator# 7434
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summary: The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.


title: Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms

summary: This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.

ReferenceCitation: Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Austria
Russian Federation
Hungary
United States
France
Mexico
Japan
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.

ReferenceCitation: Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.

location_country:
Poland
Spain
Italy
United Kingdom
Czech Republic
Hungary
France
United States
South Africa
Belgium
Netherlands
Slovakia


title: A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

summary: To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

location_country:
United Kingdom
Netherlands
Canada
Sweden
Korea, Republic of
France
United States
South Africa
Belgium
Germany
Czechia


title: A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

summary: The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Spain
Argentina
Czech Republic
Korea, Republic of
United States
France
Mexico

location_facility:
Orrin M. Troum,M D
Walter F Chase Md
Tacoma Center For Arthritis Research Ps
G. Timothy Kelly, Md
Health Research Of Oklahoma
The Arthritis Group
Local Institution
Arthritis Clinic
Desert Medical Advances


title: Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer

summary: To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

ReferenceCitation: Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.

location_country:
Poland
Spain
United Kingdom
Czech Republic
United States
France


title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Dose Ranging Study Evaluating the Efficacy and Safety of GW642444M Administered Once Daily Compared With Placebo for 28 Days in Adolescent and Adult Subjects With Persistent Asthma

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma

ReferenceCitation: Lötvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012 Sep;40(3):570-9. doi: 10.1183/09031936.00121411. Epub 2012 Feb 23.

location_country:
Poland
Russian Federation
Netherlands
Argentina
Canada
Thailand
Sweden
Korea, Republic of
United States
Chile
France
Peru
Belgium
Philippines
Germany
South Africa


type: Other Identifier

title: An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

ReferenceCitation: Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.

lead_sponsor: UCB Pharma

location_country:
Croatia
Poland
Spain
Italy
Austria
Australia
Netherlands
Finland
Czech Republic
New Zealand
Switzerland
Sweden
Hungary
France
Israel
South Africa
United Kingdom
Belgium
Norway
Germany


title: A Phase 2B Efficacy and Safety Study of PTC124 in Subjects With Nonsense-Mutation-Mediated Duchenne and Becker Muscular Dystrophy

lead_sponsor: PTC Therapeutics

ReferenceCitation: Shieh PB, Elfring G, Trifillis P, Santos C, Peltz SW, Parsons JA, Apkon S, Darras BT, Campbell C, McDonald CM; Members of the Ataluren Phase IIb Study Group; Members of the Ataluren Phase IIb Study Clinical Evaluator Training Group; Members of the ACT DMD Study Group; Members of the ACT DMD Clinical Evaluator Training Group. Meta-analyses of deflazacort versus prednisone/prednisolone in patients with nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2021 Dec;10(18):1337-1347. doi: 10.2217/cer-2021-0018. Epub 2021 Oct 25.

ReferenceCitation: Campbell C, Barohn RJ, Bertini E, Chabrol B, Comi GP, Darras BT, Finkel RS, Flanigan KM, Goemans N, Iannaccone ST, Jones KJ, Kirschner J, Mah JK, Mathews KD, McDonald CM, Mercuri E, Nevo Y, Péréon Y, Renfroe JB, Ryan MM, Sampson JB, Schara U, Sejersen T, Selby K, Tulinius M, Vílchez JJ, Voit T, Wei LJ, Wong BL, Elfring G, Souza M, McIntosh J, Trifillis P, Peltz SW, Muntoni F; PTC124-GD-007-DMD Study Group; ACT DMD Study Group; Clinical Evaluator Training Groups. Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2020 Oct;9(14):973-984. doi: 10.2217/cer-2020-0095. Epub 2020 Aug 27.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: University Clinic for Children, University of Essen

location_facility: Washington University School of Medicine

location_facility: Hadassah Medical Center, Hebrew University Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital of Boston/Harvard Medical School

location_facility: Institute For Neuromuscular Research, The Children's Hospital at Westmead

location_facility: Service de Neuropediatrie, hôpital La Timone

location_facility: Imperial College London, Hammersmith Hospital

location_facility: Robert Jones and Agnes Hunt Orthopaedic NHS Trust

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Univ of Newcastle, Institute of Human Genetics

summary: DMD/BMD is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 13 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b trial that will evaluate the clinical benefit of ataluren in boys with DMD/BMD due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve walking, activity, muscle function, and strength and whether the drug can safely be given for a long period of time.


title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia

summary: The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

ReferenceCitation: Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.

ReferenceCitation: Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.

ReferenceCitation: Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A. doi: 10.3371/CSRP.FUBO.022213.

ReferenceCitation: Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.

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

location_country:
Poland
Spain
Austria
Estonia
Russian Federation
Lithuania
Czech Republic
Ukraine
Hungary
United States
France
India
Germany
Bulgaria


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis

summary: The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

ReferenceCitation: Lee LA, Sterling R, Máspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

location_country:
Italy
Argentina
Canada
United States
Chile
France
Peru


title: A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab

lead_sponsor: Novartis Pharmaceuticals

location_country:
United Kingdom
Italy
Canada
United States
France
Germany

location_facility: Norwalk Hospital Dept of Norwalk Hospital (2)

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(3)

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC

location_facility: University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

summary: The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer


title: Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma

summary: This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.

lead_sponsor: SciClone Pharmaceuticals

location_country:
Poland
Brazil
Spain
United Kingdom
Netherlands
Argentina
Hungary
United States
Chile
France
Peru
Romania
Germany

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia

location_facility: University of California at San Francisco

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Centre Eugene Marquis, Service d'Oncologie Medicale

location_facility: Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust

location_facility: Hospital Zonal General de Agudos San Roque

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

location_facility: Tower Research Foundation at Tower Oncology

location_facility: Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet

location_facility: University of Arizona Medical Center, Arizona Cancer Center

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki

location_facility: Fovárosi Önkormányzat Uzsoki utcai Kórháza

location_facility: Institutul Oncologic 'Prof. Dr. A. Trestioreanu'

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék

location_facility: Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi

location_facility: Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center

location_facility: I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej

location_facility: Integrated Community Oncology Network, LLC

location_facility: Klinikum Region Hannover GmbH, Krankenhause Siloah

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil

location_facility: Hospital de Clínicas de Porto Alegre, Serviço de Oncologia

location_facility: Universitätsklinikum Dresden, Med. Klinik I

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro


title: Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

acronym: ASSERT

summary:
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

ReferenceCitation: Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, Norden AG, Cavassini M, Rieger A, Khuong-Josses MA, Branco T, Pearce HC, Givens N, Vavro C, Lim ML. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010 Sep;55(1):49-57. doi: 10.1097/QAI.0b013e3181dd911e.

location_country:
Denmark
Portugal
Spain
Ireland
Austria
Italy
Latvia
Netherlands
United Kingdom
Switzerland
France
Belgium
Germany


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

location_country:
Spain
Italy
United Kingdom
Czech Republic
United States
France
Germany

location_facility:
Site Reference ID/Investigator# 6234
Site Reference ID/Investigator# 6356
Site Reference ID/Investigator# 11201
Site Reference ID/Investigator# 6616
Site Reference ID/Investigator# 6609
Site Reference ID/Investigator# 6618
Site Reference ID/Investigator# 5553
Site Reference ID/Investigator# 6238
Site Reference ID/Investigator# 5549
Site Reference ID/Investigator# 7133
Site Reference ID/Investigator# 6358
Site Reference ID/Investigator# 7229
Site Reference ID/Investigator# 5557
Site Reference ID/Investigator# 6617
Site Reference ID/Investigator# 9363
Site Reference ID/Investigator# 6607
Site Reference ID/Investigator# 6615
Site Reference ID/Investigator# 8179
Site Reference ID/Investigator# 7714
Site Reference ID/Investigator# 6575
Site Reference ID/Investigator# 11202
Site Reference ID/Investigator# 5555
Site Reference ID/Investigator# 6614
Site Reference ID/Investigator# 6564
Site Reference ID/Investigator# 7911
Site Reference ID/Investigator# 6475
Site Reference ID/Investigator# 5552
Site Reference ID/Investigator# 5558
Site Reference ID/Investigator# 5554

summary: The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy


title: A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

summary: This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Macedonia, The Former Yugoslav Republic of


title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.

location_country:
Belgium
United States
France
Turkey
Mexico
Germany

summary: Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16 years.


title: A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis

summary: The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.

ReferenceCitation: Østergaard M, Bird P, Pachai C, Du S, Wu C, Landis J, Fuerst T, Ahmad HA, Connolly SE, Conaghan PG. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.

ReferenceCitation: Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.

location_country:
Spain
Italy
Australia
Netherlands
Argentina
Canada
United States
France
South Africa
Belgium
Norway
Germany

location_facility: Arthritis Clinic & Carolina Bone & Joint, Pa

location_facility: Rheumatology Associates Of North Alabama


acronym: ALEX-MT

title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures

lead_sponsor: UCB BIOSCIENCES, Inc.

ReferenceCitation: Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

location_country:
Denmark
Poland
Spain
Ireland
Austria
Australia
Italy
Canada
United Kingdom
Puerto Rico
United States
France
Germany

summary: The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.


title: A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

summary: The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

ReferenceCitation: Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. Erratum in: Ann Rheum Dis. 2012 Dec;71(12):2064.

lead_sponsor: AstraZeneca

location_country:
Poland
Romania
Russian Federation
Australia
Mexico
Argentina
Canada
Czech Republic
United States
France
Belgium
Slovakia


title: An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

ReferenceCitation: Tan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e.

location_country:
Taiwan
Canada
United States
France
Singapore

location_facility:
Site Reference ID/Investigator# 5603
Site Reference ID/Investigator# 8100
Site Reference ID/Investigator# 7616
Site Reference ID/Investigator# 6739
Site Reference ID/Investigator# 5660
Site Reference ID/Investigator# 6680
Site Reference ID/Investigator# 5652
Site Reference ID/Investigator# 5275
Site Reference ID/Investigator# 5269
Site Reference ID/Investigator# 6572
Site Reference ID/Investigator# 5650
Site Reference ID/Investigator# 8069
Site Reference ID/Investigator# 6042
Site Reference ID/Investigator# 6040
Site Reference ID/Investigator# 7756
Site Reference ID/Investigator# 7934
Site Reference ID/Investigator# 6627
Site Reference ID/Investigator# 5640
Site Reference ID/Investigator# 7868
Site Reference ID/Investigator# 6777
Site Reference ID/Investigator# 7194
Site Reference ID/Investigator# 6184
Site Reference ID/Investigator# 8068
Site Reference ID/Investigator# 5663
Site Reference ID/Investigator# 5648
Site Reference ID/Investigator# 5646
Site Reference ID/Investigator# 5534
Site Reference ID/Investigator# 5617

summary: The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.


title: A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

summary:
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection.

The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters.

Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

lead_sponsor: Gilead Sciences

location_country:
Poland
Taiwan
Hong Kong
United Kingdom
Australia
New Zealand
Canada
United States
France
Singapore
Germany


title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.

lead_sponsor: Grünenthal GmbH

location_country:
Latvia
Argentina
Ukraine
United States
Chile
France

summary: The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.


title: An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa

summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

location_country:
Croatia
Poland
Spain
Italy
Austria
Australia
New Zealand
Finland
Czech Republic
United Kingdom
Sweden
Hungary
France
Israel
South Africa
Norway
Germany


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

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

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

ReferenceCitation: Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Serbia
Lithuania
Ukraine
United States
Romania
Belgium
Poland
Austria
Australia
Russian Federation
India
Israel
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Latvia
New Zealand
France
Netherlands

intervention_type: Other


acronym: ENEST

title: A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
Czech Republic
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: Wayne State University/Wertz Clinical Cancer Center

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: UCLA's Jonsson Comprehensive Cancer Center

location_facility: University of Texas/MD Anderson Cancer Center

location_facility: Washington Hospital Center - Washington Cancer Institute

location_facility: St. Vincent's Comprehensive Cancer Center

summary: The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.


title: A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL

lead_sponsor: Sanofi

location_country:
United Kingdom
Italy
Australia
Netherlands
Puerto Rico
United States
France
Belgium
Germany

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840003

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 840022

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 840018

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 840023

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 826004

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 630001

summary:
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.

Primary objective is to determine overall response rate.

The secondary objectives are:

to assess overall safety,
to assess duration of response, progression free survival, and overall survival.

Clinical benefit and pharmacokinetics parameters are also evaluated.


title: An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension

ReferenceCitation: Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.

location_country:
Poland
Brazil
Italy
Hungary
France
United States
India
South Africa
Belgium
Turkey

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.


title: Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma

acronym: OPTIMUM

summary: The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

ReferenceCitation: Kropff M, Baylon HG, Hillengass J, Robak T, Hajek R, Liebisch P, Goranov S, Hulin C, Bladé J, Caravita T, Avet-Loiseau H, Moehler TM, Pattou C, Lucy L, Kueenburg E, Glasmacher A, Zerbib R, Facon T. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica. 2012 May;97(5):784-91. doi: 10.3324/haematol.2011.044271. Epub 2011 Dec 1.

ReferenceCitation: Kropff M, et al. OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 959

lead_sponsor: Celgene

location_country:
Croatia
Poland
Portugal
Serbia
United Kingdom
Italy
Hungary
France
India
South Africa
Philippines
Germany
Bulgaria
Slovakia
Czechia

location_facility: Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University

location_facility: Klinika Hematologii Uniwersytetu Medycznego

location_facility: Clinic for Hematology, Clinical Centre Nis

location_facility: Department of Internal Medicine - Baguio General Hospital & Medical Center

location_facility: Department of Medical Oncology, Jaslok Hospital and Research Centre

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

location_facility: Haematology Department - King's College Hospital

location_facility: Institute of Hematology, Clinical Centre of Serbia

location_facility: Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych

location_facility: Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum

location_facility: Military Medical Academy/Dept Haematology and Oncology

location_facility: Med. Klinik II/Klinikum of the Julius-Maximilians-University

location_facility: KBC Zagreb - Klinika za Unutarnje Bolesti

location_facility: Chris Hani Baragwanath Hospital, Clinical Haematology Unit

location_facility: Department of Medical Oncology, Amrita Institute of Medical Sciences

location_facility: Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna

location_facility: Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University

location_facility: Universitaetsklinik - Abteilung Innere Medizin III

location_facility: Universitaetsklinik - Klinik fur innere Medizin

location_facility: Clinic of Haematology, Multiprofiled Hospital for Active Treatment "Sveta Marina"

location_facility: Abteilung Haematologie - Univeresitaetsklinikum

location_facility: Szent-Gyorgyi Albert University II Clinic of Internal Medicine

location_facility: Klinika Hematologii Akademii Medycznej w Gdanskuul

location_facility: Department of Medical Oncology, S.L. Raheja Hospital

location_facility: Department of Internal Medicine, National Cancer Institute

location_facility: Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust

location_facility: Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung

location_facility: Klinicka Bolnica "Dubrava" Klinika za Unutarnje Bolesti

location_facility: Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik

location_facility: Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat

location_facility: National Center of Haematology & Transfusiology

location_facility: Department of Medical Oncology, Deenanath Mangeshkar Hospital

location_facility: Nizam's Institute of Medical Sciences, Department of Medical Oncology

location_facility: University of Multiprofiled Hospital for Active Treatment "Alexandrovska" - Sofia

location_facility: Department of Haematology, UCT Medical School

location_facility: SPSK, Klinika Hematologii Akademii Medycznej

location_facility: Hematologie - CHU Purpan Place du Dr. Baylac

location_facility: Interni Klinika, Oddeleni Hematoonkologie

location_facility: Medizinische Klinik Abteilung Innere V/Universitatsklinikum

location_facility: Clinic of Haematology, University Multiprofiled Hospital for Active Treatment "G. Stranski"

location_facility: Klinika Chorob Wewnetrznych i Hemagologii

location_facility: Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti

location_facility: Klinicki Bolnicki Centar Rijeka Interna Klinika

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii

location_facility: Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova

location_facility: Hospital da Universidade de Coimbra - Servico de Hematologia Clinica

location_facility: Johannesburg Hospital, Department of Medical Oncology

location_facility: Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen

location_facility: Department of Medical Oncology, Dayanand Medical College DMCH

location_facility: Oncology Research Unit Heartlands Hospital

location_facility: Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti

location_facility: Clinic for Hematology, Clinical Centre Novi Sad

location_facility: Tygerberg Hospital, University of Stellenbosch, Department of Haematology

location_facility: Hematology Department University Hospital

location_facility: Hospital Geral de Santo Antonio - Servico de Hematologia Clinica

location_facility: University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology

location_facility: Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove

location_facility: Universitat Schleswig Holstein II Med. Klinik

location_facility: Abt. Haematologie - Onkologie/ Allg. Krankenhaus

location_facility: Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna

location_facility: Department of Medical Oncology/Regional Cancer Centre

location_facility: Instituto di Ematologia e Oncologia Medica

location_facility: Doctors Clinic - National Kidney & Transplant Institute

location_facility: Klinicka Bolnica "Sestre milosrdnice" Klinika za Unutarnje Bolesti

location_facility: Department of Medical Oncology/Tata Memorial Hospital

location_facility: Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej

location_facility: Hematology Department, University Hospital PJS


title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s

summary: To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Estonia
Australia
Canada
Finland
France
India
South Africa
Belgium
Germany
Bulgaria
Slovakia


title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

summary: This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany


title: Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

summary: The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

ReferenceCitation: Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country: Poland Spain Ukraine France Germany Bulgaria Czechia


title: A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

ReferenceCitation: Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbé C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.

location_country:
Spain
Italy
Australia
Argentina
Canada
Finland
Switzerland
Hungary
United States
France
Belgium
Germany

location_facility: University of California at Los Angeles Dept. of Hematology-Oncology

location_facility: University of Pittsburgh Medical Center Department of Dermatology

location_facility: Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)

location_facility: University of Michigan Health System Michigan HouseClinTrialsOffice

location_facility: MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201

location_facility: Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr

location_facility: Oregon Health & Science University Dept. of OHSU Cancer Institute

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: Boston Medical Center StudyCoordinator:CLBH589B2201

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic

location_facility: Indiana University Dept. of IU Cancer Center

location_facility: Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed

summary: This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.


title: Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life

summary: To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

ReferenceCitation: Porst H, Gacci M, Büttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

ReferenceCitation: Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.

lead_sponsor: Eli Lilly and Company

location_country:
Austria
United States
France
Mexico
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 Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

summary: This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Czech Republic
Hungary
France
South Africa
Germany


title: A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

summary: The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

lead_sponsor: Sesen Bio, Inc.

location_country:
Croatia
Poland
Brazil
Romania
Serbia
Italy
Russian Federation
Spain
United Kingdom
Argentina
Ukraine
Hungary
France
India
Israel
Mexico
Germany
Slovakia

location_facility: State Medical Institution Regional Clinical Oncology Dispensary

location_facility: Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

location_facility: Tambov Regional Oncological Dispensary Surgery Department

location_facility: Zaporozhye Regional Clinical Oncology Dispensary

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii

location_facility: PHI OAO RRW Railway Clinical Hospital at station Gorkiy

location_facility: Centro Regional Integrado de Oncologia - CRIO

location_facility: Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital

location_facility: Oradea Clinical County Hospital Department of Medical Oncology

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: CECAN - Centro do Câncer Francisco Cunha Filho

location_facility: Santo André Diagnósticos e Tratamentos Ltda

location_facility: Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery

location_facility: PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways

location_facility: Hospital Municipal de Agudos Leonidas Lucero

location_facility: Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department

location_facility: Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery

location_facility: Central Clinical Hospital #2 after MA Semashko OAO "RRW"

location_facility: Wojewodzki Szpital Specjalistyczny im. L.Rydygiera

location_facility: SIH Leningrad Regional Oncology Dispansery

location_facility: Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology

location_facility: Asian Institute of Oncology, S L Raheja Hospital

location_facility: Centre Régional de Lutte contre le Cancer Val d'Aurelle

location_facility: State Medical Institution Kursk Regional Oncology Dispensary Out-patient department

location_facility: Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet

location_facility: Centro Anticanceroso de la Cruz Roja Mexicana de Mérida

location_facility: Hospital de Clinicas "Jose de San Martin"

location_facility: Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre

location_facility: Military Medical Academy (MMA) Clinic for Maxillofacial Surgery

location_facility: Kharkov Regional Clinical Oncology Dispensary

location_facility: Department of Medical Oncology Dayanand Medical College & Hospital

location_facility: Debreceni Egyetem OEC, Onkologiai Tanszek

location_facility: Moscow Scientific-Research Oncology Institute after P.A. Gertsen

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: SPBSIH City Clinical Oncology Dispensary

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Instituto Ribeirãopretano de Combate ao Câncer

location_facility: Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery

location_facility: Cettro - Centro de Tratamento Oncológico Ltda.

location_facility: Universtity Hospital for Tumors, Department for Head and Neck Surgery

location_facility: Republican Clinical Oncological Dispenser Radiological Therapy

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

location_facility: Birla Cancer Institute SMS Medical College Hospital

location_facility: Biocor - Hospital de Doenças Cardiovasculares Ltda

location_facility: Department of Medical Oncology, Bangalore Institute of Oncology

location_facility: Pro-Onco Centro De Tratamento Oncológico S/C Ltda

location_facility: SI Russian Oncology Scientific Center after NN Blokhin RAMS

location_facility: Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology

location_facility: Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny

location_facility: Netaji Subash Chandra Bose Cancer Research Institute

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: "Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department

location_facility: Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)


status: Active, not recruiting

title: An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer

study_completion_date_type: Anticipated

lead_sponsor: Genzyme, a Sanofi Company

ReferenceCitation: Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24. Erratum in: J Clin Oncol. 2013 Aug 20;31(24):3049.

location_country:
Serbia
Spain
Italy
United States
Romania
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
India
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Korea, Republic of
France
Netherlands

location_facility:
Investigational Site Number 1601
Investigational Site Number 2502
Investigational Site Number 2005
Investigational Site Number 7
Investigational Site Number 1901
Investigational Site Number 2901
Investigational Site Number 2602
Investigational Site Number 21
Investigational Site Number 2801
Investigational Site Number 6
Investigational Site Number 2001
Investigational Site Number 2501
Investigational Site Number 2403
Investigational Site Number 1204
Investigational Site Number 13
Investigational Site Number 3402
Investigational Site Number 2803
Investigational Site Number 3002
Investigational Site Number 2101
Investigational Site Number 19
Investigational Site Number 2802
Investigational Site Number 2302
Investigational Site Number 1205
Investigational Site Number 1501
Investigational Site Number 2503
Investigational Site Number 3
Investigational Site Number 8
Investigational Site Number 1703
Investigational Site Number 10
Investigational Site Number 3102
Investigational Site Number 1102
Investigational Site Number 14
Investigational Site Number 2301
Investigational Site Number 1402
Investigational Site Number 3301
Investigational Site Number 3003
Investigational Site Number 1202
Investigational Site Number 2902
Investigational Site Number 1401
Investigational Site Number 2506
Investigational Site Number 1801
Investigational Site Number 1001
Investigational Site Number 2701
Investigational Site Number 9
Investigational Site Number 2504
Investigational Site Number 1702
Investigational Site Number 2
Investigational Site Number 2402
Investigational Site Number 1701
Investigational Site Number 3401
Investigational Site Number 1203
Investigational Site Number 3001
Investigational Site Number 2102
Investigational Site Number 1101
Investigational Site Number 3101
Investigational Site Number 1201
Investigational Site Number 11
Investigational Site Number 2404
Investigational Site Number 2002
Investigational Site Number 3601
Investigational Site Number 22
Investigational Site Number 2505
Investigational Site Number 18
Investigational Site Number 2601
Investigational Site Number 15
Investigational Site Number 17

summary: The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

status_simplified: Ongoing