title: A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Spain
Italy
United Kingdom
Peru
Romania
Belgium
Czechia
Poland
Hong Kong
Austria
Russian Federation
Argentina
Mexico
Brazil
Canada
Hungary
Germany
Estonia
Thailand
Korea, Republic of
France
Netherlands

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Hospital de Sagunto; Servicio de Oncologia

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Great Western Hospital; Clinical Oncology

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Instituto de Investigaciones Clínicas Quilmes

location_facility: Municipal Clinical Hospital Filantropia; Oncology

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

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

location_facility: Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit

location_facility: Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Fejér Megyei Szent György Kórház; Onkológiai Osztály

location_facility: Regional Oncology Hospital of Krasnodar; Oncology

location_facility: A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

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

location_facility: Institut Jean Godinot; Oncologie Medicale

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

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: S.-Peterburg Pavlov State Medical University ; Haematology

location_facility: Seoul National University Hosp; Dept Internal Med Hem Onc

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Masarykuv onkologicky ustav; Oncology II

location_facility: Wojewodzki Szpital Zespolony; Oddzial Chemioterapii

location_facility: Spitalul Clinic Sf. Maria; Departmental De Oncologie

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Klinikum Bremen-Mitte gGmbH; Frauenklinik

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Uni Hospital For Tumours; Dept of Medical Oncology

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica II

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Korea University Guro Hospital; Oncology

location_facility: Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Kaposi Mor County Hospital; Dept. of Oncology

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: ASST DI CREMONA; Dipartimento Aziendale Oncologico

location_facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Oncologia Sul Capixaba Servicos Medicos - Oncosul

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Semashko Central Clinical Hospital; Dept of Chemotherapy

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: University Hospital of North Durham; Oncology

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.


status: Completed

primary_purpose: Diagnostic

acronym: Triptocare

intervention_type: Drug

title: Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study

study_completion_date_type: Actual

lead_sponsor: Ipsen

type: EudraCT Number

source: euctr

study_type: Interventional

enrollment_type: Actual

location_country:
Denmark
Romania
Spain
Italy
Latvia
United Kingdom
Lithuania
France
Belgium
Netherlands

location_facility: IRCCS Fondazione S. Raffaele del Monte Tabor

summary: The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

acronym: Neptune

summary: Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.

ipd_sharing: Yes

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

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Poland
Belarus
United Kingdom
Italy
Austria
Netherlands
Russian Federation
Czech Republic
Hungary
France
Belgium
Germany
Slovakia


acronym: ACE

title: Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations

lead_sponsor: Daiichi Sankyo, Inc.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

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/

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Utrecht University Medical Centre, Dept. of Hematology

location_facility: Unita Trapianti di Midollo Osseo per Adulti

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Clinica Ematologica

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z

location_facility: Institut Catala d'Oncologia del Hospital Universitari Germans

location_facility: Universita Degli Studi di Roma Tor Vergata

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer

location_facility: Universitatsklinikum Leipzig Selbstandige Abteilung fur Hamatologie

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire Brabois

location_facility: Centre Henry Becquerel, Service d'Hematologie

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Instituto Di Ematologia "L.Ea. Seragnoli"

location_facility: Hanmmersmith Hospital, Dept. of Hematology

location_facility: Hospital Universitario de Salamanca, Hospital Clinico, Servicio de Hematologia

location_facility: Instituto Catalan de Oncologia-Hospital Universitari de Girona

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: Uniklinik Essen, Westdeutsches Tumorzentrum

location_facility: Presidio Ospedaliero "A. Businco" - Centro di Riferimento Oncologico Regionale

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Regional Universitaire, Hopital de Hautepierre

location_facility: Saint James University Hospital, Institute of Oncology

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Hospital de la Princesa, Servicio de Hematologia

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Universitatsklinikum Regensburg Abteilung fur Hamatologie

summary: AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).


title: A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

acronym: SQUIRE

summary: The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafrański W, Ramlau R, Bálint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.

ReferenceCitation: Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.

ReferenceCitation: Reck M, Socinski MA, Luft A, Szczęsna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.

ReferenceCitation: Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Philippines
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Singapore
Slovakia
Brazil
Canada
Hungary
Germany
Taiwan
Greece
Thailand
Korea, Republic of
France

location_facility:
ImClone Investigational site
ImClone Investigational Site

intervention_type: Biological

status_simplified: Ongoing


title: A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

summary: The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

ReferenceType: result

ReferenceCitation: Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

lead_sponsor: AstraZeneca

location_country:
Portugal
Romania
Spain
Greece
Italy
Estonia
Mexico
Finland
Argentina
Netherlands
Russian Federation
Sweden
Korea, Republic of
France
Puerto Rico
United Kingdom
Belgium
Germany


title: Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone

summary:
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows:

Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg

location_country:
Denmark
Poland
Romania
Spain
Austria
Netherlands
Russian Federation
Ukraine
France
Belgium
Germany
Bulgaria
Slovakia
Czechia


title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Hong Kong
Russian Federation
Australia
Argentina
Israel
Mexico
Canada
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

location_facility: Loma Linda Oncology Medical Group Loma Linda

location_facility: University of Washington Cancer Care Seattle Cancer Alliance

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)

location_facility: Henry Ford Hospital Dept. of Henry Ford Hospital

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.


ipd_sharing: Undecided

title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

ReferenceCitation: Pivot X, Manikhas A, Żurawski B, Chmielowska E, Karaszewska B, Allerton R, Chan S, Fabi A, Bidoli P, Gori S, Ciruelos E, Dank M, Hornyak L, Margolin S, Nusch A, Parikh R, Nagi F, DeSilvio M, Santillana S, Swaby RF, Semiglazov V. CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2015 May 10;33(14):1564-73. doi: 10.1200/JCO.2014.57.1794. Epub 2015 Jan 20.

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:
Denmark
Poland
Spain
Greece
Italy
Russian Federation
United Kingdom
Thailand
Sweden
Hungary
United States
France
Belgium
Germany

summary: This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.


title: Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence

lead_sponsor: H. Lundbeck A/S

ReferenceCitation: Gual A, He Y, Torup L, van den Brink W, Mann K; ESENSE 2 Study Group. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 Nov;23(11):1432-42. doi: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.

ReferenceCitation: Aubin HJ, Reimer J, Nutt DJ, Bladström A, Torup L, François C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

ReferenceCitation: Laramée P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, François C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

ReferenceCitation: van den Brink W, Aubin HJ, Bladström A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19. Erratum in: Alcohol Alcohol. 2013 Nov-Dec;48(6):746.

location_country:
Poland
Portugal
Spain
Italy
Czech Republic
France
Belgium

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.


title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

ReferenceCitation: Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, Schett G, Amital H, Navarro-Sarabia F, Hou A, Bernasconi C, Huizinga TW. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50. doi: 10.1136/annrheumdis-2011-201282. Epub 2012 May 5.

ReferenceCitation: Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, Gerli R, Hansen MS, Amital H, Xavier RM, Troum O, Bernasconi C, Huizinga TW. Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study. Ann Rheum Dis. 2014 May;73(5):803-9. doi: 10.1136/annrheumdis-2013-204761. Epub 2014 Jan 28.

ReferenceCitation: Dougados M, Huizinga TW, Choy EH, Bingham CO 3rd, Aassi M, Bernasconi C. Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1762-6. doi: 10.1002/acr.22633.

ReferenceCitation: Huizinga TW, Conaghan PG, Martin-Mola E, Schett G, Amital H, Xavier RM, Troum O, Aassi M, Bernasconi C, Dougados M. Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. Ann Rheum Dis. 2015 Jan;74(1):35-43. doi: 10.1136/annrheumdis-2014-205752. Epub 2014 Aug 28.

location_country:
Denmark
Croatia
Brazil
Serbia
Spain
Greece
Italy
Estonia
Latvia
Netherlands
Russian Federation
Thailand
United Kingdom
Sweden
United States
France
Israel
Romania
Norway
Germany


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

summary: This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

primary_purpose: Prevention

ReferenceCitation: Bonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089.

ReferenceCitation: Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.

ReferenceCitation: Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.

ReferenceCitation: Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.

ReferenceCitation: Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.

ReferenceCitation: Inciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27.

ReferenceCitation: Bergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10.

ReferenceCitation: Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.

ReferenceCitation: Corbalán R, Nicolau JC, López-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.

ReferenceCitation: Yin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933.

ReferenceCitation: Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998.

ReferenceCitation: Wang K, Li H, Kwong WJ, Antman EM, Ruff CT, Giugliano RP, Cohen DJ, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8). pii: e006703. doi: 10.1161/JAHA.117.006703.

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Hamershock RA, Lewis BS, Hassager C, Chao TF, Le Heuzey JY, Mercuri M, Rutman H, Antman EM, Giugliano RP. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7). pii: e006035. doi: 10.1161/JAHA.117.006035.

ReferenceCitation: De Caterina R, Renda G, Carnicelli AP, Nordio F, Trevisan M, Mercuri MF, Ruff CT, Antman EM, Braunwald E, Giugliano RP. Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382. doi: 10.1016/j.jacc.2016.12.031. Erratum in: J Am Coll Cardiol. 2019 Feb 12;73(5):627.

ReferenceCitation: Link MS, Giugliano RP, Ruff CT, Scirica BM, Huikuri H, Oto A, Crompton AE, Murphy SA, Lanz H, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1). pii: e004267. doi: 10.1161/CIRCEP.116.004267.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Murphy SA, Brown K, Jarolim P, Mercuri M, Antman EM, Morrow DA. Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006. doi: 10.1001/jamacardio.2016.3311.

ReferenceCitation: Steffel J, Giugliano RP, Braunwald E, Murphy SA, Mercuri M, Choi Y, Aylward P, White H, Zamorano JL, Antman EM, Ruff CT. Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178. doi: 10.1016/j.jacc.2016.06.034. Erratum in: J Am Coll Cardiol. 2017 Jul 25;70(4):512-513.

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Nordio F, Corbalán R, Dalby A, Dorobantu M, Mercuri M, Lanz H, Rutman H, Wiviott SD, Antman EM, Giugliano RP. Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7). pii: e003735. doi: 10.1161/JAHA.116.003735.

ReferenceCitation: Rost NS, Giugliano RP, Ruff CT, Murphy SA, Crompton AE, Norden AD, Silverman S, Singhal AB, Nicolau JC, SomaRaju B, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82. doi: 10.1161/STROKEAHA.116.013540. Epub 2016 Jul 7.

ReferenceCitation: Bohula EA, Giugliano RP, Ruff CT, Kuder JF, Murphy SA, Antman EM, Braunwald E. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36. doi: 10.1161/CIRCULATIONAHA.116.022361.

ReferenceCitation: Kato ET, Giugliano RP, Ruff CT, Koretsune Y, Yamashita T, Kiss RG, Nordio F, Murphy SA, Kimura T, Jin J, Lanz H, Mercuri M, Braunwald E, Antman EM. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5). pii: e003432. doi: 10.1161/JAHA.116.003432.

ReferenceCitation: Xu H, Ruff CT, Giugliano RP, Murphy SA, Nordio F, Patel I, Shi M, Mercuri M, Antman EM, Braunwald E. Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2). pii: e002587. doi: 10.1161/JAHA.115.002587.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95. doi: 10.1016/S0140-6736(14)61943-7. Epub 2015 Mar 11.

ReferenceCitation: Mega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, Murphy SA, Lee J, Mercuri MF, Giugliano RP, Antman EM, Braunwald E, Sabatine MS. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7. doi: 10.1016/S0140-6736(14)61994-2. Epub 2015 Mar 11.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Mercuri M, Curt V, Betcher J, Grip L, Cange AL, Crompton AE, Murphy SA, Deenadayalu N, Antman EM. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84. doi: 10.1016/j.jacc.2014.05.028.

ReferenceCitation: Giugliano RP, Ruff CT, Rost NS, Silverman S, Wiviott SD, Lowe C, Deenadayalu N, Murphy SA, Grip LT, Betcher JM, Duggal A, Dave J, Shi M, Mercuri M, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8. doi: 10.1161/STROKEAHA.114.006025. Epub 2014 Jun 19.

ReferenceCitation: Gupta DK, Shah AM, Giugliano RP, Ruff CT, Antman EM, Grip LT, Deenadayalu N, Hoffman E, Patel I, Shi M, Mercuri M, Mitrovic V, Braunwald E, Solomon SD; Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 Echocardiographic Study Investigators. Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65. doi: 10.1093/eurheartj/eht500. Epub 2013 Dec 2.

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

ReferenceCitation: Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May;107(5):925-36. doi: 10.1160/TH11-08-0566. Epub 2012 Mar 8.

ReferenceCitation: Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

ReferenceCitation: Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Mexico
Brazil
Canada
Guatemala
Hungary
Germany
Greece
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France


title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma

summary: This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Finland
Czech Republic
Switzerland
United Kingdom
Hungary
France
Israel
Singapore
Belgium
Norway
Germany


title: Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

acronym: OPTION

summary: This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

ReferenceCitation: Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aimé E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.

ReferenceCitation: Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.

lead_sponsor: LivaNova

location_country:
Portugal
United Kingdom
Italy
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Heart Center Virga Jesse Ziekenhuis - Hasselt

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

intervention_type: Device


title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

summary: The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

ReferenceCitation: Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

ReferenceCitation: Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.

ReferenceCitation: Malavera A, You S, Zheng D, Delcourt C, Anderson CS; INTERACT2 Investigators. Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study. J Neurol Sci. 2021 Apr 15;423:117364. doi: 10.1016/j.jns.2021.117364. Epub 2021 Feb 26.

ReferenceCitation: Sandset EC, Wang X, Carcel C, Sato S, Delcourt C, Arima H, Stapf C, Robinson T, Lavados P, Chalmers J, Woodward M, Anderson CS. Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2. Eur Stroke J. 2020 Dec;5(4):345-350. doi: 10.1177/2396987320957513. Epub 2020 Sep 20.

ReferenceCitation: Song L, Wang X, Ouyang M, Sun L, Chen X, Arima H, Sandset EC, Delcourt C, Wang J, Chen G, Robinson T, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2021 Jan;52(2):722-725. doi: 10.1161/STROKEAHA.120.030435. Epub 2021 Jan 11.

ReferenceCitation: Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.

ReferenceCitation: You S, Zheng D, Delcourt C, Sato S, Cao Y, Zhang S, Yang J, Wang X, Lindley RI, Robinson T, Anderson CS, Chalmers J. Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1409-1414. doi: 10.1161/STROKEAHA.118.024403. Epub 2019 Apr 18.

ReferenceCitation: Wang X, Sandset EC, Moullaali TJ, Chen G, Song L, Carcel C, Delcourt C, Woodward M, Robinson T, Chalmers J, Arima H, Anderson CS; INTERACT2 Investigators. Determinants of the high admission blood pressure in mild-to-moderate acute intracerebral hemorrhage. J Hypertens. 2019 Jul;37(7):1463-1466. doi: 10.1097/HJH.0000000000002056.

ReferenceCitation: Chen R, Wang X, Anderson CS, Robinson T, Lavados PM, Lindley RI, Chalmers J, Delcourt C. Infratentorial Intracerebral Hemorrhage. Stroke. 2019 May;50(5):1257-1259. doi: 10.1161/STROKEAHA.118.023766.

ReferenceCitation: Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.

ReferenceCitation: Delcourt C, Sato S, Zhang S, Sandset EC, Zheng D, Chen X, Hackett ML, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Robinson T, Davies L, Lavados PM, Lindley RI, Stapf C, Chalmers J, Anderson CS; INTERACT2 Investigators. Intracerebral hemorrhage location and outcome among INTERACT2 participants. Neurology. 2017 Apr 11;88(15):1408-1414. doi: 10.1212/WNL.0000000000003771. Epub 2017 Feb 24.

ReferenceCitation: Delcourt C, Zheng D, Chen X, Hackett M, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Woodward M, Huang Y, Robinson T, Lavados PM, Lindley RI, Stapf C, Davies L, Chalmers J, Anderson CS, Sato S; INTERACT Investigators. Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):70-75. doi: 10.1136/jnnp-2016-314414. Epub 2016 Oct 21.

ReferenceCitation: Muñoz Venturelli P, Wang X, Zahuranec DB, Lavados PM, Stapf C, Lindley R, Delcourt C, Chalmers J, Anderson CS, Robinson TG, Robinson TG; INTERACT2 Investigators. Withdrawal of active treatment after intracerebral haemorrhage in the INTERACT2 study. Age Ageing. 2017 Mar 1;46(2):329-332. doi: 10.1093/ageing/afw187.

ReferenceCitation: Song L, Sandset EC, Arima H, Heeley E, Delcourt C, Chen G, Yang J, Wu G, Wang X, Lavados PM, Huang Y, Stapf C, Wang J, Robinson TG, Chalmers J, Lindley RI, Anderson CS; INTERACT2 Investigators. Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1330-1335. doi: 10.1136/jnnp-2016-313246. Epub 2016 May 13.

ReferenceCitation: Qiu M, Sato S, Zheng D, Wang X, Carcel C, Hirakawa Y, Sandset EC, Delcourt C, Arima H, Wang J, Chalmers J, Anderson CS; INTERACT Investigators*. Admission Heart Rate Predicts Poor Outcomes in Acute Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies. Stroke. 2016 Jun;47(6):1479-85. doi: 10.1161/STROKEAHA.115.012382. Epub 2016 May 10.

ReferenceCitation: Carcel C, Wang X, Sato S, Stapf C, Sandset EC, Delcourt C, Arima H, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 Investigators*. Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 Results. Stroke. 2016 Jun;47(6):1651-3. doi: 10.1161/STROKEAHA.116.013326. Epub 2016 May 3.

ReferenceCitation: Delcourt C, Zhang S, Arima H, Sato S, Al-Shahi Salman R, Wang X, Davies L, Stapf C, Robinson T, Lavados PM, Chalmers J, Heeley E, Liu M, Lindley RI, Anderson CS; INTERACT2 investigators. Significance of Hematoma Shape and Density in Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial Study. Stroke. 2016 May;47(5):1227-32. doi: 10.1161/STROKEAHA.116.012921. Epub 2016 Apr 12.

ReferenceCitation: Muñoz-Venturelli P, Wang X, Lavados PM, Stapf C, Robinson T, Lindley R, Heeley E, Delcourt C, Chalmers J, Anderson CS; INTERACT2 Investigators. Prophylactic heparin in acute intracerebral hemorrhage: a propensity score-matched analysis of the INTERACT2 study. Int J Stroke. 2016 Jul;11(5):549-56. doi: 10.1177/1747493016641113. Epub 2016 Mar 23.

ReferenceCitation: Zheng D, Arima H, Sato S, Gasparrini A, Heeley E, Delcourt C, Lo S, Huang Y, Wang J, Stapf C, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 investigators. Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study. PLoS One. 2016 Feb 9;11(2):e0149040. doi: 10.1371/journal.pone.0149040. eCollection 2016.

ReferenceCitation: Sato S, Delcourt C, Heeley E, Arima H, Zhang S, Al-Shahi Salman R, Stapf C, Woo D, Flaherty ML, Vagal A, Levi C, Davies L, Wang J, Robinson T, Lavados PM, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage. Stroke. 2016 Mar;47(3):701-7. doi: 10.1161/STROKEAHA.115.012147. Epub 2016 Feb 4.

ReferenceCitation: Saxena A, Anderson CS, Wang X, Sato S, Arima H, Chan E, Muñoz-Venturelli P, Delcourt C, Robinson T, Stapf C, Lavados PM, Wang J, Neal B, Chalmers J, Heeley E; INTERACT2 Investigators. Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage: The INTERACT2 Study. Stroke. 2016 Mar;47(3):682-8. doi: 10.1161/STROKEAHA.115.011627. Epub 2016 Jan 26.

ReferenceCitation: Yu S, Arima H, Heeley E, Delcourt C, Krause M, Peng B, Yang J, Wu G, Chen X, Chalmers J, Anderson CS; INTERACT2 Investigators. White blood cell count and clinical outcomes after intracerebral hemorrhage: The INTERACT2 trial. J Neurol Sci. 2016 Feb 15;361:112-6. doi: 10.1016/j.jns.2015.12.033. Epub 2015 Dec 22.

ReferenceCitation: Moullaali TJ, Sato S, Wang X, Rabinstein AA, Arima H, Carcel C, Chen G, Robinson T, Heeley E, Chan E, Delcourt C, Stapf C, Cordonnier C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of delayed intraventricular haemorrhage in the INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):19-24. doi: 10.1136/jnnp-2015-311562. Epub 2016 Jan 8.

ReferenceCitation: Wang X, Arima H, Yang J, Zhang S, Wu G, Woodward M, Muñoz-Venturelli P, Lavados PM, Stapf C, Robinson T, Heeley E, Delcourt C, Lindley RI, Parsons M, Chalmers J, Anderson CS; INTERACT2 Investigators. Mannitol and Outcome in Intracerebral Hemorrhage: Propensity Score and Multivariable Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 2 Results. Stroke. 2015 Oct;46(10):2762-7. doi: 10.1161/STROKEAHA.115.009357. Epub 2015 Aug 11.

ReferenceCitation: Sato S, Arima H, Heeley E, Hirakawa Y, Delcourt C, Lindley RI, Robinson T, Huang Y, Morgenstern L, Stapf C, Wang J, Chalmers J, Anderson CS; INTERACT2 Investigators. Off-Hour Admission and Outcomes in Patients with Acute Intracerebral Hemorrhage in the INTERACT2 Trial. Cerebrovasc Dis. 2015;40(3-4):114-20. doi: 10.1159/000434690. Epub 2015 Jul 18.

ReferenceCitation: Heeley E, Anderson CS, Woodward M, Arima H, Robinson T, Stapf C, Parsons M, Lavados PM, Huang Y, Wang Y, Crozier S, Parry-Jones A, Wang J, Chalmers J; INTERACT2 Investigators. Poor utility of grading scales in acute intracerebral hemorrhage: results from the INTERACT2 trial. Int J Stroke. 2015 Oct;10(7):1101-7. doi: 10.1111/ijs.12518. Epub 2015 Jun 4.

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS. Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies. Cerebrovasc Dis. 2015;39(3-4):242-8. doi: 10.1159/000381107. Epub 2015 Mar 25.

ReferenceCitation: Wang X, Arima H, Heeley E, Delcourt C, Huang Y, Wang J, Stapf C, Robinson T, Woodward M, Chalmers J, Anderson CS; INTERACT2 Investigators. Magnitude of blood pressure reduction and clinical outcomes in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial study. Hypertension. 2015 May;65(5):1026-32. doi: 10.1161/HYPERTENSIONAHA.114.05044. Epub 2015 Mar 23.

ReferenceCitation: Yang J, Arima H, Wu G, Heeley E, Delcourt C, Zhou J, Chen G, Wang X, Zhang S, Yu S, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of perihematomal edema in acute intracerebral hemorrhage: pooled analysis from the intensive blood pressure reduction in acute cerebral hemorrhage trial studies. Stroke. 2015 Apr;46(4):1009-13. doi: 10.1161/STROKEAHA.114.007154. Epub 2015 Feb 24.

ReferenceCitation: Chan E, Anderson CS, Wang X, Arima H, Saxena A, Moullaali TJ, Heeley E, Delcourt C, Wu G, Wang J, Chen G, Lavados PM, Stapf C, Robinson T, Chalmers J, Huang Y; INTERACT2 Investigators. Significance of intraventricular hemorrhage in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial results. Stroke. 2015 Mar;46(3):653-8. doi: 10.1161/STROKEAHA.114.008470. Epub 2015 Feb 12.

ReferenceCitation: Priglinger M, Arima H, Anderson C, Krause M; INTERACT Investigators. No relationship of lipid-lowering agents to hematoma growth: pooled analysis of the intensive blood pressure reduction in acute cerebral hemorrhage trials studies. Stroke. 2015 Mar;46(3):857-9. doi: 10.1161/STROKEAHA.114.007664. Epub 2015 Feb 5.

ReferenceCitation: Sato S, Heeley E, Arima H, Delcourt C, Hirakawa Y, Pamidimukkala V, Li Z, Tao Q, Xu Y, Hennerici MG, Robinson T, Tzourio C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators, Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang LJ, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J. Higher mortality in patients with right hemispheric intracerebral haemorrhage: INTERACT1 and 2. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1319-23. doi: 10.1136/jnnp-2014-309870. Epub 2015 Jan 14.

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS; INTERACT Investigators. Clinical prediction algorithm (BRAIN) to determine risk of hematoma growth in acute intracerebral hemorrhage. Stroke. 2015 Feb;46(2):376-81. doi: 10.1161/STROKEAHA.114.006910. Epub 2014 Dec 11.

ReferenceCitation: Rådholm K, Arima H, Lindley RI, Wang J, Tzourio C, Robinson T, Heeley E, Anderson CS, Chalmers J; INTERACT2 Investigators. Older age is a strong predictor for poor outcome in intracerebral haemorrhage: the INTERACT2 study. Age Ageing. 2015 May;44(3):422-7. doi: 10.1093/ageing/afu198. Epub 2014 Dec 13.

ReferenceCitation: Manning L, Hirakawa Y, Arima H, Wang X, Chalmers J, Wang J, Lindley R, Heeley E, Delcourt C, Neal B, Lavados P, Davis SM, Tzourio C, Huang Y, Stapf C, Woodward M, Rothwell PM, Robinson TG, Anderson CS; INTERACT2 investigators. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014 Apr;13(4):364-73. doi: 10.1016/S1474-4422(14)70018-3. Epub 2014 Feb 13.

ReferenceCitation: Chen G, Arima H, Wu G, Heeley E, Delcourt C, Zhang P, Rabinstein AA, Robinson T, Stapf C, Huang Y, Song L, Yang J, Wang X, Li Q, Chen X, Chalmers J, Anderson C; INTERACT2 Investigators. Subarachnoid extension of intracerebral hemorrhage and 90-day outcomes in INTERACT2. Stroke. 2014 Jan;45(1):258-60. doi: 10.1161/STROKEAHA.113.003524. Epub 2013 Oct 22.

ReferenceCitation: Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

ReferenceCitation: Delcourt C, Stapf C, Tzourio C, Héritier S, Anderson C. [The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): protocol and baseline characteristics of patients included in France]. Rev Neurol (Paris). 2012 Apr;168(4):321-7. doi: 10.1016/j.neurol.2011.08.010. Epub 2011 Nov 29. French.

lead_sponsor: The George Institute

location_country:
Brazil
Hong Kong
Portugal
Italy
Austria
Australia
Spain
Argentina
Finland
Switzerland
United Kingdom
United States
Chile
China
France
Belgium
India
Germany
Pakistan

location_facility: Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere

location_facility: Regional Coordinating Centre India: The George Institute India

location_facility: Hospital General Universitario de Albacete

location_facility: Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University

location_facility: Regional Coordinating Centre United Kingdom

location_facility: Universitatsklinikum Ulm, Oberer Eselsberg

location_facility: Regional Coordinating Centre China: The George Institute China

location_facility: Royal Brisbane and Women's Hospital Health Service District

intervention_type: Other


acronym: LEAD

title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

location_country:
Denmark
Poland
Brazil
Serbia
Greece
Latvia
Russian Federation
Finland
Sweden
Korea, Republic of
France
Romania
Norway
Netherlands

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

location_facility: Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine

location_facility: University of Medicine and Pharmacy Iuliu Hatieganu

location_facility: Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna

location_facility: Hôpital Du Cluzeau - Service de Médecine B

location_facility: Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon

location_facility: I.M. Sechenov Moscow Medical Academy - Endocrinology Department

location_facility: Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department

location_facility: Metaxa Hospital - Department of Endocrinology

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9

location_facility: Hôpital du Bocage Sud - Service d'Endocrinologie

location_facility: Arhus University Hospital - Department of Medicinsk AVd M

location_facility: Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13

location_facility: Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division

location_facility: Hopital Pitié-Salpêtrière - Service d'Endocrinologie

location_facility: Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

location_facility: CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition

location_facility: Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center

location_facility: Hôpital Haut Lévêque - Unité de soins normalisés

location_facility: Skane University Hospital, Department of Endocrinology

location_facility: Department of Medicine, Haukeland Hospital Jonas Lies

location_facility: CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B

location_facility: Righospitalet - University Department of Endocrinology & Internal Medicine P

location_facility: Polykliniki Hospital - Department of Endocrinology

location_facility: Hôpital Avicenne - Bâtiment Madeleine Breis

location_facility: Erasmus Medical Centre - Department of Endocrinology

location_facility: Hôpital Archet 1 - Service d'Endocrinologie

location_facility: Seoul National University hospital, 28 Yongon-dong Chongno-gu

location_facility: P. Stradins Clinical University Hospital - Department of Endocrinology

location_facility: Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

location_facility: UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

location_facility: Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

location_facility: University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17

location_facility: Evangelismos Hospital - Department of Endocrinology

location_facility: Odense University Hospital - Department of Endocrinology

location_facility: Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine

location_facility: Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism

location_facility: Sungkyunkwan University Samsung Medical Center

location_facility: Hôpital Neurologique - Pierre Wertheimer

location_facility: B IKA Panagia Hospital - Department of Endocrinology

summary: The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg


acronym: SAVE-ONCO

title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy

lead_sponsor: Sanofi

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Romania
South Africa
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Indonesia
India
Israel
Mexico
Norway
Malaysia
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
Finland
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
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summary:
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

acronym: MAIDEN

summary: Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

lead_sponsor: Bayer

location_country:
Denmark
Poland
United Kingdom
Greece
Italy
Russian Federation
Finland
Lithuania
Sweden
Hungary
France
South Africa
Germany