acronym: RE-COVER II

title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™. Vasc Med. 2016 Dec;21(6):506-514. Epub 2016 Nov 1.

ReferenceCitation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

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Ukraine
United States
South Africa
Philippines
Poland
Russian Federation
Australia
India
Israel
Turkey
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Bulgaria
Denmark
Taiwan
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

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summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.


type: EudraCT Number

type: Other Identifier

title: AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS

acronym: POEM

summary: The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: ViiV Healthcare

location_country:
Brazil
Spain
Greece
Italy
United Kingdom
Canada
Puerto Rico
France
United States
Belgium
Germany

location_facility: University of South Carolina School of Medicine

location_facility: UT Southwestern Medical Center HIV/AIDS Research Unit

location_facility: Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital

location_facility: University of California Irvine Medical Center

location_facility: Hospital General Universitário de Alicante

location_facility: Infectious Diseases Associates of Central Virginia

location_facility: Southern Illinois University School of Medicine

location_facility: Ambulatorio Day Hospital Malattie Infettive

location_facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli

location_facility: Infectious Disease Research Institute, Inc

location_facility: Hôpital Haut - Leveque - Centre Francois Magendie

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: ifi-Institut am Allgemeines Krankenhaus St.Georg

location_facility: Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia

location_facility: Hopital Jean Verdier, Unite de maladies infectieuses

location_facility: Arztpraxis fuer Innere Medizin Dr. Knechten

location_facility: Hull & East Yorkshire Hospitals NHS Trust

location_facility: Louisiana State University Health Sciences Center

location_facility: SOD Malattie Infettive, La Piastra dei Servizi

location_facility: 1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco

location_facility: Montgomery Infectious Disease Associates, P.A. (Private Practice)

location_facility: Tarrant County Infectious Disease Associates

location_facility: Dipartimento di Medicina Clinica Specialistica e Sperimentale

location_facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH

location_facility: Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario Germans Tias I Pujol

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: Division of Infectious Diseases, George Washington University Medical Center

location_facility: Alta Bates Summit Medical Center East Bay AIDS Center

location_facility: University of Toledo: Health Sciences Campus

location_facility: Michigan State University College of Osteopathic Medicine

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Mount Sinai Downtown Comprehensive Health Program

location_facility: Yale University School of Medicine Aids Program

location_facility: South Florida Infectious Deisease and Tropical Medicine Center

location_facility: ID Consultants Inc & Infectious Disease Research Corp.

location_facility: Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: Infectomed GbR Zentrum für medizinische Studien

location_facility: Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.

location_facility: Erie County Medical Center, HIV Services

location_facility: AOUP Paolo Giaccone, UOC Malattie Infettive

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt

location_facility: Klinik I fuer Innere Medizin der Uni-Klinik Koeln

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: A Professional Corporation, Research Department

location_facility: Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero

location_facility: Tarrant County Infectious Disease Assocciates

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: The Ohio State University Medical Center

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Royal Free Hospital, Ian Charleson Day Centre

location_facility: Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria

location_facility: Kaiser Permanete of Colorado Rock Creek Medical Offices

location_facility: University of Iowa Hospitals and Clinics

location_facility: Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: Hospital of the J.W. Goethe University, Medical Clinic II

location_facility: University of British Columbia/ Downtown Infectious Diseases Clinic

location_facility: Kaiser Permanente Northwest Region, Immune Deficiency Clinic

location_facility: George Washington University Medical Faculty Assoc

location_facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

location_facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

location_facility: Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco

location_facility: Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,

location_facility: Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

summary: The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Spain
Greece
Austria
Italy
Russian Federation
Czech Republic
Hungary
France
South Africa
Turkey
Romania
Germany


title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

ReferenceType: derived

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16. Review.

ReferenceCitation: Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Singapore
Brazil
Canada
Germany
Denmark
Czech Republic
Korea, Republic of
France
Chile

location_facility: Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

location_facility: St. Francis Sleep Allergy & Lung Institute

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: Anne Arundel Health System Research Institute, Inc.

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Jobst Vascular Center At The Toledo Hospital

location_facility: Scripps Clinic/Scripps Health And Green Hospital

location_facility: Primary Care Of The Treasure Coast, Inc.


title: A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

acronym: AGENDA

summary: This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].

ReferenceCitation: Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. Epub 2006 Sep 11.

lead_sponsor: Genta Incorporated

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

location_facility: Azienda Ospedaliera Universitaria di Siena

location_facility: Nottingham University Hospitals NHS Trust, City Campus

location_facility: Hospital of the University of Schleswig-Holstein

location_facility: Klinik und Poliklinik fur Dermatologie und Venerologie

location_facility: Morristown Memorial - Atlantic Healthcare System

location_facility: Charles University, Dermatology Department

location_facility: Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum

location_facility: Klinik und Poliklinik fur Hautkrankheiten

location_facility: Istituto Nazionale dei Tumori "G. Pascale"

location_facility: Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: Medical University of Vienna, Vienna General Hospital

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

location_facility: Sydney Cancer Center, Royal Prince Alfred Hospital

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie

location_facility: Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie

location_facility: University of South Alabama Hospital, Mitchell Cancer Institute

location_facility: MD Anderson Cancer Center at University of Texas

location_facility: San Diego Pacific Oncology and Hematology Associates Inc.

location_facility: CHU de Grenoble, Hopital Albert Michallon

location_facility: Siouxland Hematology Oncology Associates

location_facility: Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck


title: A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

acronym: INTORSECT

summary: This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Hutson TE, Escudier B, Esteban E, Bjarnason GA, Lim HY, Pittman KB, Senico P, Niethammer A, Lu DR, Hariharan S, Motzer RJ. Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):760-7. doi: 10.1200/JCO.2013.50.3961. Epub 2013 Dec 2.

lead_sponsor: Pfizer

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
Finland
Switzerland
Sweden
Hungary
Korea, Republic of
United States
Chile
China
France
Singapore
United Kingdom
Germany


ipd_sharing: Yes

acronym: ENESTnd

title: A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

lead_sponsor: Novartis Pharmaceuticals

type: Registry Identifier

source: euctr

ReferenceCitation: Hughes TP, Hochhaus A, Kantarjian HM, Cervantes F, Guilhot F, Niederwieser D, le Coutre PD, Rosti G, Ossenkoppele G, Lobo C, Shibayama H, Fan X, Menssen HD, Kemp C, Larson RA, Saglio G. Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily. Haematologica. 2014 Jul;99(7):1204-11. doi: 10.3324/haematol.2013.091272. Epub 2014 Feb 14.

ReferenceCitation: Hughes TP, Saglio G, Kantarjian HM, Guilhot F, Niederwieser D, Rosti G, Nakaseko C, De Souza CA, Kalaycio ME, Meier S, Fan X, Menssen HD, Larson RA, Hochhaus A. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014 Feb 27;123(9):1353-60. doi: 10.1182/blood-2013-06-510396. Epub 2013 Dec 11.

ReferenceCitation: Hochhaus A, Saglio G, Larson RA, Kim DW, Etienne G, Rosti G, De Souza C, Kurokawa M, Kalaycio ME, Hoenekopp A, Fan X, Shou Y, Kantarjian HM, Hughes TP. Nilotinib is associated with a reduced incidence of BCR-ABL mutations vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Blood. 2013 May 2;121(18):3703-8. doi: 10.1182/blood-2012-04-423418. Epub 2013 Mar 15.

ReferenceCitation: Branford S, Kim DW, Soverini S, Haque A, Shou Y, Woodman RC, Kantarjian HM, Martinelli G, Radich JP, Saglio G, Hochhaus A, Hughes TP, Müller MC. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012 Dec 10;30(35):4323-9. doi: 10.1200/JCO.2011.40.5217. Epub 2012 Oct 29.

ReferenceCitation: Larson RA, Yin OQ, Hochhaus A, Saglio G, Clark RE, Nakamae H, Gallagher NJ, Demirhan E, Hughes TP, Kantarjian HM, le Coutre PD. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur J Clin Pharmacol. 2012 May;68(5):723-33. doi: 10.1007/s00228-011-1200-7. Epub 2011 Dec 30.

ReferenceCitation: Kantarjian HM, Hochhaus A, Saglio G, De Souza C, Flinn IW, Stenke L, Goh YT, Rosti G, Nakamae H, Gallagher NJ, Hoenekopp A, Blakesley RE, Larson RA, Hughes TP. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011 Sep;12(9):841-51. doi: 10.1016/S1470-2045(11)70201-7. Epub 2011 Aug 17. Erratum in: Lancet Oncol. 2011 Oct;12(11):989.

ReferenceCitation: Cortes JE, Hochhaus A, le Coutre PD, Rosti G, Pinilla-Ibarz J, Jabbour E, Gillis K, Woodman RC, Blakesley RE, Giles FJ, Kantarjian HM, Baccarani M. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011 May 26;117(21):5600-6. doi: 10.1182/blood-2010-11-318949. Epub 2011 Apr 5.

ReferenceCitation: Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM; ENESTnd Investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9. doi: 10.1056/NEJMoa0912614. Epub 2010 Jun 5.

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

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

location_country:
Spain
Italy
United Kingdom
Venezuela
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Austria
Russian Federation
Argentina
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Kaiser Permanente - California Southern Dept of Kaiser South 3

location_facility: Michigan State University / Breslin Cancer Center Breslin Cancer Center

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

location_facility: University of North Carolina UNC Lineberger Cancer Center

location_facility: Florida Cancer Specialists Dept. FloridaCancerSpecialists

location_facility: Kansas City Cancer Center KCCC Business Office

location_facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

location_facility: Cancer Centers of Florida PA Cancer Centers of FL

location_facility: Advanced Medical Specialties Research Dept.

location_facility: University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics

location_facility: Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center

location_facility: Kaiser Permanente - California Northern Kaiser Med

location_facility: Hackensack University Medical Center Department of Research

location_facility: Memorial Sloan Kettering Cancer Center Clinical Trials Office

location_facility: Tennessee Oncology Dept. of Centennial Medical

location_facility: Texas Cancer Center ( Medical City Dallas Hospital)

location_facility: Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants

location_facility: Florida Retina Institute Flordia Cancer Affilates

location_facility: Kaiser Permanente - California Northern Vallejo Med Center/Med Offices

location_facility: University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.

location_facility: Wake Forest University Health Sciences Dept. of Industry Research

location_facility: University of Chicago Section of Hematology/Oncology

location_facility: Rocky Mountain Cancer Centers RMCC - Colorado Springs

location_facility: Missouri Cancer Associates Dept. of Boone Hospital Center

location_facility: University of California at Los Angeles Dept. of Hematology Clinic

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

summary:
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

ReferenceCitation: Harrington K, Temam S, Mehanna H, D'Cruz A, Jain M, D'Onofrio I, Manikhas G, Horvath Z, Sun Y, Dietzsch S, Dubinsky P, Holeckova P, El-Hariry I, Franklin N, Biswas-Baldwin N, Legenne P, Wissel P, Netherway T, Farrell J, Ellis C, Wang-Silvanto J, Amonkar M, Ahmed N, Santillana S, Bourhis J. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Oncol. 2015 Dec 10;33(35):4202-9. doi: 10.1200/JCO.2015.61.4370. Epub 2015 Nov 2.

lead_sponsor: GlaxoSmithKline

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Philippines
Hong Kong
Austria
Russian Federation
Argentina
India
Slovakia
Canada
Hungary
China
Germany
Greece
Ireland
Estonia
Czech Republic
Thailand
France

intervention_type: Radiation


title: A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

summary: This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

location_country:
Spain
Italy
Ireland
Mexico
Netherlands
Lithuania
United Kingdom
Switzerland
France
Belgium
Germany


title: Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study

acronym: EOS

summary: The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

ReferenceType: result

ReferenceCitation: Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201. Review.

lead_sponsor: AstraZeneca

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

location_facility: Altana Pharma/Nycomed Investigational Sites


title: A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

summary: To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

status: Terminated

location_country: Portugal Spain Greece Canada France Turkey Sweden

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic

location_facility: University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin

location_facility: Hospital General Universitario de Alicante

location_facility: Serviço de Endocrinologia - Hospital de Egas Moniz

location_facility: Associação Protectora dos Diabéticos de Portugal

location_facility: Dokuz Eylul University Medical School, Department of Endocrinology

location_facility: Hospital General Universitario Valle de Hebron

location_facility: "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic

location_facility: Hôpital Jeanne d'Arc - Dommartin les Toul

location_facility: CHU Cote de Nacre, Service d'Endocrinologie

location_facility: "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic

location_facility: Douglas Tweel M.D. Professional Corporation

location_facility: Hopital LA Cavale Blanche, Service de Diabetologie

location_facility: Istanbul University Istanbul Medical School, Department of Endocrinology

location_facility: Hospital Universitario Central de Asturias

location_facility: Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department

location_facility: Hacettepe University Medical School Department of Endocrinology

location_facility: Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition

location_facility: Groupe Hospitalier Sud/Service d'Endocrinologie

intervention_type: Other

status_simplified: Unknown


title: A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone

summary: The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.

ReferenceCitation: Ryckmans V, Kahn JP, Modell S, Werner C, McQuade RD, Kerselaers W, Lissens J, Sanchez R. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study. Pharmacopsychiatry. 2009 May;42(3):114-21. doi: 10.1055/s-0028-1112134. Epub 2009 May 18.

location_country:
Spain
Greece
Austria
Italy
United Kingdom
Czech Republic
Hungary
France
Belgium
Germany


title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure

acronym: EMPHASIS-HF

summary:
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone

design_allocation: Non-Randomized

ReferenceCitation: Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31.

ReferenceCitation: Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WHW, Böhm M, Pitt B, Zannad F, Rossignol P. Prognostic relevance of magnesium alterations in patients with a myocardial infarction and left ventricular dysfunction: insights from the EPHESUS trial. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):148-159. doi: 10.1093/ehjacc/zuab111.

ReferenceCitation: Ferreira JP, Lamiral Z, McMurray JJV, Swedberg K, van Veldhuisen DJ, Vincent J, Rossignol P, Pocock SJ, Pitt B, Zannad F. Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial. Circ Heart Fail. 2021 Jun;14(6):e008075. doi: 10.1161/CIRCHEARTFAILURE.120.008075. Epub 2021 Jun 15.

ReferenceCitation: Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WWH, Böhm M, Pitt B, Zannad F, Rossignol P. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial. Clin Res Cardiol. 2022 Apr;111(4):380-392. doi: 10.1007/s00392-021-01853-8. Epub 2021 Apr 23.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

ReferenceCitation: Monzo L, Ferreira JP, Abreu P, Szumski A, Böhm M, McMurray JJV, Pitt B, Swedberg K, van Veldhuisen DJ, Girerd N, Vincent J, Zannad F, Rossignol P. Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275.

ReferenceCitation: Stienen S, Ferreira JP, Vincent J, Busselen M, Li B, McMurray JJV, Pitt B, Girerd N, Rossignol P, Zannad F. Estimated Long-Term Survival With Eplerenone. J Am Coll Cardiol. 2019 May 14;73(18):2357-2359. doi: 10.1016/j.jacc.2019.02.043.

ReferenceCitation: Ferreira JP, Duarte K, McMurray JJV, Pitt B, van Veldhuisen DJ, Vincent J, Ahmad T, Tromp J, Rossignol P, Zannad F. Data-Driven Approach to Identify Subgroups of Heart Failure With Reduced Ejection Fraction Patients With Different Prognoses and Aldosterone Antagonist Response Patterns. Circ Heart Fail. 2018 Jul;11(7):e004926. doi: 10.1161/CIRCHEARTFAILURE.118.004926.

ReferenceCitation: Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2.

ReferenceCitation: Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27.

ReferenceCitation: Krum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013 Jul;6(4):711-8. doi: 10.1161/CIRCHEARTFAILURE.112.000173. Epub 2013 Apr 26.

ReferenceCitation: Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5.

ReferenceCitation: Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.

ReferenceCitation: Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Spain
Italy
United Kingdom
Ukraine
Venezuela
United States
Belgium
South Africa
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Mexico
Singapore
Sweden
Slovakia
Canada
Hungary
Germany
Greece
Ireland
Korea, Republic of
France
Netherlands
United Arab Emirates


title: A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

summary:
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

primary_purpose: Prevention

ReferenceCitation: Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10.

ReferenceCitation: HSV-040 Study Group, Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P. Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial. Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.

ReferenceCitation: Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

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.

location_country:
Denmark
Romania
Spain
Greece
United Kingdom
Australia
Estonia
Canada
Lithuania
New Zealand
Sweden
Hungary
United States
France
Norway
Belgium
Iceland
Netherlands

intervention_type: Biological


title: Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)

summary:
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.

In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone

ReferenceCitation: Zucca E, Conconi A, Laszlo D, López-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7.

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Belgium

location_facility: Worchestershire Acute Hospital NHS Trust

location_facility: A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2

location_facility: A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia


title: A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects.

summary: The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.

ReferenceCitation: Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.

location_country:
Denmark
United Kingdom
Italy
Finland
Canada
Sweden
United States
France
Norway
Germany


title: A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.

summary:
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).

The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.

ReferenceCitation: Kahrilas PJ, Persson T, Denison H, Wernersson B, Hughes N, Howden CW. Predictors of either rapid healing or refractory reflux oesophagitis during treatment with potent acid suppression. Aliment Pharmacol Ther. 2014 Sep;40(6):648-56. doi: 10.1111/apt.12877. Epub 2014 Jul 15.

location_facility:
Research Siteq
Research Site


title: An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

summary: This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

lead_sponsor: UCB Pharma

location_country:
Serbia
Spain
Italy
Ukraine
United States
Belgium
South Africa
Czechia
Poland
Hong Kong
Austria
Russian Federation
Tunisia
Israel
Norway
Singapore
Sweden
Canada
Switzerland
Hungary
Germany
Taiwan
Finland
Korea, Republic of
France
Netherlands


title: An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation

summary: Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

ReferenceCitation: van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hené RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6.

ReferenceCitation: van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tönshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.

ReferenceCitation: Höcker B, van Gelder T, Martin-Govantes J, Machado P, Tedesco H, Rubik J, Dehennault M, Garcia Meseguer C, Tönshoff B; FDCC Study Group. Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.

ReferenceCitation: van Gelder T, Tedesco Silva H, de Fijter JW, Budde K, Kuypers D, Arns W, Soulillou JP, Kanellis J, Zelvys A, Ekberg H, Holzer H, Rostaing L, Mamelok RD. Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation. 2010 Mar 15;89(5):595-9. doi: 10.1097/TP.0b013e3181ca7d84.

ReferenceCitation: van Schaik RH, van Agteren M, de Fijter JW, Hartmann A, Schmidt J, Budde K, Kuypers D, Le Meur Y, van der Werf M, Mamelok R, van Gelder T. UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009 Sep;86(3):319-27. doi: 10.1038/clpt.2009.83. Epub 2009 Jun 3.

lead_sponsor: Erasmus Medical Center

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
United Kingdom
Austria
Australia
Estonia
Canada
Lithuania
Netherlands
Sweden
Venezuela
France
China
Belgium
Norway
Germany

location_facility: Complejo Hospitalario Univeritario de Santiago

location_facility: Karolinska University Hospital, Huddinge

location_facility: Institute of Transplantology, Medical University of Warsaw

location_facility: Surgical Clinic Of Tartu University Clinics

location_facility: Centre Hospitalier Regional Universitaire

location_facility: West China Hospital of Sichuan University


title: Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

summary: The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

location_country: Italy Canada Hungary India France Germany


title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma

summary: The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Belgium
Netherlands


title: A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2

summary: This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.

lead_sponsor: Solvay Pharmaceuticals

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
Sweden
France
Norway
Germany

location_facility:
Site 43
Site 51
Site 52
Site 48
Site 35
Site 34
Site 19
Site 60
Site 63
Site 56
Site 7
Site 24
Site 42
Site 37
Site 32
Site 25
Site 31
Site 22
Site 12
Site 40
Site 14
Site 13
Site 8
Site 5
Site 27
Site 2
Site 10
Site 47
Site 20
Site 6
Site 57
Site 29
Site 36
Site 54
Site 11
Site 44
Site 46
Site 58
Site 41
Site 16
Site 45
Site 55
Site 64
Site 62
Site 4
Site 39
Site 18
Site 61
Site 21
Site 50
Site 15
Site 3
Site 33
Site 38
Site 49
Site 17
Site 26
Site 23
Site 59
Site 28
Site 30
Site 53
Site 9


title: A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

summary: The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

study_completion_date_type: Anticipated

ReferenceCitation: Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010. pii: bcr1120092495. doi: 10.1136/bcr.11.2009.2495.

lead_sponsor: Cell Genesys

location_country:
Poland
United Kingdom
Italy
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Seattle Cancer Care Alliance, Univ. of Washington

location_facility: North Shore Hematology Oncology Associates P.C.

location_facility: Institut Jean Godinot, Oncologie Medicale

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Center for Oncology Research & Treatment, PA

location_facility: Katedra i Klinika Onkologii i Radioterapli

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie

location_facility: Department of Oncology Hammersmith Hospital

location_facility: Centre Hospitalier Universite de Sherbrooke

location_facility: Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata

location_facility: Scunthorpe General Hospital, Dept of Oncology

location_facility: Kaiser Permanente Medical Group Dept. of Oncology Research

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz

location_facility: Wojewodzki Szpital Specjalistyczny Oddzial Urologii

location_facility: Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu

location_facility: Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne

location_facility: Jupiter Hematology & Oncology Associates

location_facility: Azienda Ospedaliera Maggiore della Carita

location_facility: Rosemere Cancer Centre, Royal Preston Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: General Clinical Research Center University of Michigan

location_facility: Desert Hematology Oncology Medical Group

location_facility: Ziekenhuis Netwerk Antwerpen - AZ Middelheim

location_facility: Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen

location_facility: Cancer Center and Department of Medicine

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie

location_facility: Centre Rene Gauducheau - Site Hospitalier Nord

location_facility: Peachtree Hematology & Oncology Consultants, PC

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Universitatsklinikum Carl Gustav Carus An Der

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach

location_facility: Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara

location_facility: Azienda Ospedaliero Universitaria di Modena


title: A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

summary: The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

ReferenceCitation: Carbonell-Estrany X, Simões EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.

lead_sponsor: MedImmune LLC

location_country:
Spain
Italy
United Kingdom
United States
Iceland
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
New Zealand
Czech Republic
France
Chile

location_facility: Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii

location_facility: Shands Hospital At The University Of Florida

location_facility: Children's Healthcare D.B.A. Hospitals & Clinics

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Sioux Valley Hospital University of South Dakota Medical Center

location_facility: Saint-Petersburg State Pediatric Medical Academy

location_facility: CHU Montpellier/Hoptial Arnaud de Villeneuve

location_facility: University Of Texas Houston Medical School

location_facility: University of Michigan Mott Children's Hospital

location_facility: Zentrum Klinische Studien/Universtatsklinikum Freiburg

location_facility: East Carolina University School of Medicine

location_facility: Beehly Medical Park Women's and Children's Pav.

location_facility: Universitatskinderlinik/Zentrum Fur klinische Studien

location_facility: Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"

location_facility: Hospital Universitario de Universidade de Sao Paulo

location_facility: Hospital Das Clinicas Da Faculdade De Medicina

location_facility: Jefferson-duPont Children's Health Program

location_facility: Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara

location_facility: Specialized Hospital for Active Treatment of Pediatric Diseases

location_facility: Nemours Children's Clinic Biomedical Research

location_facility: McGill University Health Centre Monteal Children's Hospital

location_facility: University of Nebraska Medical Center Pediatric

location_facility: Aristotele University of Thessaloniki, General "AXEPA" Hospital

location_facility: Univ. Of Texas Southwestern Medical Center

location_facility: Szpital Morski im. PCK, Oddział Dziecięcy

location_facility: University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics

location_facility: Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie

location_facility: St. Petersburg City Outpatient Hospital #45

location_facility: Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki

location_facility: The Children's Clinic Of Jonesboro, P.A.

location_facility: Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Children's Hospital Medical Center Of Akron

location_facility: Hippokration Hospital, University of Thessaloniki

location_facility: University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic

location_facility: Allgemeines KrankenHaus Universitatsklinkiken Wein

location_facility: Children's hospital, Landspitali University Hospital

location_facility: Georgia Pediatric Pulmonology Associates

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Manitoba Institute Of Child Health University of Manitoba

location_facility: Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin

location_facility: Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna

location_facility: University Of Alberta/Stollery Children's Hospital

location_facility: Louisiana State University MidCity Clinic

location_facility: Azienda USL di Imola - Ospedale di Imola

location_facility: Paediatrisk Afdeling Herning Centralsygehus

location_facility: Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza

location_facility: Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"

location_facility: Centre Hospitalier de L'Universite Laval

location_facility: Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale

location_facility: Multifunctional Hospital for Active Treatment "St. Marina"

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.

location_facility: Univ. S. Florida Pediatrics Ambulatory Care Center

location_facility: Wake Forest University School of Medicine

location_facility: Hospital Clinic y Maternistat - Barcelona

location_facility: University Of Maryland School of Medicine

location_facility: Klinik und Poliklinik und Jugendiche der Universitat Leipzig

location_facility: Service de Medecine Neonatale et de reanimation pediatrique

location_facility: University Of Texas Health Science Center

location_facility: St. Petersburg State Pediatric Medical Academy

location_facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases

location_facility: Hospital Peiade Interzonal General de Augodos

location_facility: Hospital Materno Infantil/Neumología pediátrica

location_facility: Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale

location_facility: II Klinika Chorób Dzieci PAM, Samodzielny Publiczny

location_facility: Geisinger Medical Center- JW Children's Hospital

location_facility: Katedra i Klinika Neonatologii AM w Poznaniu

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii

location_facility: Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital

location_facility: Hospital Clinico de la Universidad de Chile

location_facility: Universitatsklinik fur Kinder und Jugenheilkunde, Graz

location_facility: CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B

location_facility: Queen's Medical Centre Nottingham University Hospital

location_facility: Fakultni Thomayerova nemocnice S poliklinkou

location_facility: Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Multifunctional Hospital for Active Treatment "Pleven"

location_facility: Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo

location_facility: Hospital e Maternidade Celso Pierro-Puccamp

location_facility: Multifunctional Hospital for Active Treatment - Plovdiv

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Asklepios Kinderklinik Sankt Augustin GmbH

location_facility: Hospital Clinico Universitario de Santiago

location_facility: University Hospital State University of New York at Stony Brook Department of Pediatrics

location_facility: Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka

location_facility: Kapiolani Medical Center for Woman and Children

location_facility: Hospital General De Ninos Pedro De Elizalde

location_facility: Centre Pediatrique Gatien de Clocheville

location_facility: Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"

location_facility: University of North Carolina-School of Medicine

location_facility: Pediatric Clinical Trials International, Inc.


title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1

summary: The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

ReferenceCitation: Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.

ReferenceCitation: Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.

lead_sponsor: Human Genome Sciences Inc.

location_country:
Poland
Australia
Canada
Czech Republic
France
Israel
Romania
Germany

location_facility: University of Berlin, Charite Campus Virchow Klinikum

location_facility: University of Orleans, Hopital de la Source

location_facility: Katedra i Oddzial Kliniczny Chorob Zakaznych

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: Katedra i Klinika Chorob Zakaznych i Hepatologii

location_facility: University of Creteil, Hopital Henri Mondor

location_facility: University of Bochum, Kliniken Bergmannsheil

location_facility: Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: University of Marseille, Hopital Saint Joseph

location_facility: University of Paris, Hopital Saint-Antoine

location_facility: University of Toulouse, Clinique Dieulafoy

location_facility: University of Hamburg, Hospital Hamburg Eppendorf

location_facility: University of Lyon, Hopital de l'Hotel Dieu

location_facility: University of Paris, Hopital Pitie-Salpetriere

location_facility: University of Lille, Hopital Claude Huriez

location_facility: McMaster Clinic - Hamilton General Hospital

location_facility: Klinika Hepatologii i Nabytych Niedoborow Immunologicznych


title: A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)

summary: This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Canada
Thailand
Puerto Rico
United States
France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects

acronym: MOTIVATE 2

summary: Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

ReferenceCitation: Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.

ReferenceCitation: Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

ReferenceCitation: Hardy WD, Gulick RM, Mayer H, Fätkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.

ReferenceCitation: Fätkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.

ReferenceCitation: Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.

lead_sponsor: ViiV Healthcare

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


title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Vahdat LT, Vrdoljak E, Gómez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.

ReferenceCitation: Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.

ReferenceCitation: Roché H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.

lead_sponsor: R-Pharm

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Singapore
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands


title: A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

ReferenceCitation: Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roché HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. Epub 2007 Oct 29.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Poland
Argentina
Mexico
Sweden
Malaysia
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Thailand
Korea, Republic of
France


title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

ReferenceCitation: Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71.

location_country:
Spain
United Kingdom
United States
Belgium
Philippines
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Greece
New Zealand
Czech Republic
Korea, Republic of
France
Chile


title: Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
Spain
Austria
Canada
United States
France
Germany

location_facility: Medical Group of North County, Inc., San Diego Cancer Center

location_facility: Service de Pneumology, Hopital Adulte de Brabois

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: Hematology Oncology Patient Enterprises, Center for Cancer Care

location_facility: Hospital de Sagunto Servicio de Oncologia

location_facility: St. Luke's/Mountain State Tumor Institute (MSTI)

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: Pacific Coast Hematology/Oncology Medical Group, Inc.

location_facility: Comprehensive Cancer Care Specialists of Boca Raton

location_facility: South Florida Oncology & Hematology Consultants

location_facility: Coast Hematology and Oncology Associates

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Centre Hospitalier General de la Region Annecienne

location_facility: Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque

location_facility: Louisiana State University Health Sciences Center

location_facility: Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.

location_facility: Hospital Clinico Universitario, Servicio Hematologia y Oncologia

location_facility: University of Oklahoma Health Sciences Center

location_facility: Oncology Hematology of Lehigh Valley, PC

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Hospital Universitario La Fe Servicio de Oncologia

location_facility: UCSF/Mount Zion Comprehensive Cancer Center

location_facility: New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates

location_facility: University of Medicine & Dentistry of NJ, School of Osteopathic Medicine

location_facility: New York Presbyterian Hospital, Weill Medical College of Cornell University

location_facility: University of Cincinnati, Barrett Cancer Center

location_facility: South Shore Hematology Oncology Associates, PC

location_facility: Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach

location_facility: Columbus Community Clinical Oncology Program

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: Tulane University Health Sciences Center

location_facility: New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates

location_facility: Oncology/Hematology, Kaiser Permanente Northwest

location_facility: Southern California Kaiser Permanente Medical Group

location_facility: Oncology/Hematology Associates of Central Illinois, P.C.

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: Kansas City Oncology and Hematology Group, Kansas City Cancer Centers

location_facility: Eastern Connecticut Hematology & Oncology

location_facility: Northwest Carolina Oncology and Hematology, P.A.

location_facility: Georgia Oncology Partners Research & Education Foundation

location_facility: Algoma Regional Cancer Program - Sault Area Hospital

location_facility: Montana Cancer & Infectious Disease Specialists

location_facility: Hospital Arnau de Villanova, Servicio de Oncologia

location_facility: Hematology & Oncology Associates of South Texas

location_facility: Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie