summary: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

ReferenceCitation: Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine +/- pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0. Erratum In: BMC Cancer. 2019 Jun 24;19(1):620.

repository_institution: Kyoto University - Kyoto University Research Information Repository

publisher_dissemination: Springer-Nature

ReferenceCitation: Bighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Okayama University Hospital; Breast, Thyroid Surgery

location_facility: Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: The Don & Sybil Harrington Cancer Center; Department of Clinical Research

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Kitakyushu Municipal Medical Center; Surgery

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Toranomon Hospital; Breast and Endocrine Surgery

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Kumamoto University Hospital; Breast and Endocrine Surgery

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Centro de Investigacion; Clinica Del Pacifico

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Hackensack Uni Medical Center; Northern Nj Cancer Center

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

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Cuse - Centre Universitaire De Sante; Site Fleurimont

location_facility: Maharaj Nakorn Hospital; Internal Medicine

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

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

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy

location_facility: Tri-Service General Hospital; Hematology and Oncology

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: National Cancer Center Hospital; Breast and Medical Oncology

location_facility: Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii

location_facility: University Hospital of Larissa; Oncology

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Ospedale Papardo- Piemonte;Oncologia Medica

location_facility: Shizuoka Cancer Center; Female Internal Medicine

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

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

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Little Rock Hematology Oncology Associates, PA

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: University of California; Moores Cancer Center

location_facility: Ryazan State Medical University Named after I.P.Pavlov

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

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hyogo College Of Medicine; Breast And Endocrine Surgery

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

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Uni of Texas Southwestern Medical Center

location_facility: Korea University Guro Hospital; Oncology

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Nebraska Methodist Hospital; Cancer Center

location_facility: Saitama Medical University International Medical Center; Medical Oncology

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Jichi Medical University; Breast Oncology

location_facility: St. John'S Mercy Medical Center; David C. Pratt Cancer Center

location_facility: Gunma University Hospital; Department of Breast and Endocrine Surgery

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Uni of Colorado Cancer Center; Anschutz Cancer Pavilion

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Centre D'Oncologie de Gentilly; Oncology

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Peterborough City Hospital; Oncology Ward

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

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

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Mater Misericordiae Hospital; Chemotherapy Cottage

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Gifu University Hospital; Second Department of Surgery

location_facility: Innovative Medical Research of South Florida

location_facility: Seoul National University Bundang Hospital; Hematology Medical Oncology

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: National Hospital Organization Hokkaido Cancer Center; Breast Surgery

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Kanazawa University Hospital; Breast Oncology

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

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

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Tokai University Hospital, Breast and Endocrine Surgery

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Tohoku University Hospital; Breast And Endocrine Surgery

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Kantonsspital Baden; Medizinische Klinik, Onkologie

location_facility: Instituto Colombiano Para El Avance De La Medicina: Icamedic

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: James Graham Brown Cancer Center, University of Louisville

location_facility: Showa University Hospital; Breast Surgery

location_facility: Osaka University Hospital; Breast and Endocrine Surgery

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Columbia Comprehensive Cancer Center Clinic

location_facility: Cancer Research Center of Hawaii; Clinical Sciences

location_facility: The Providence Regional Medical Center Everett

location_facility: Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Mikawa Breast Cancer Clinic; Breast Surgery

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Southampton General Hospital; Somers Cancer Research Building

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

location_facility: Kyorin University Hospital; Breast Surgery

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: South Carolina Oncology Associates - SCRI

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

title: A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer


study_start_date_type: Actual

acronym: A+B

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

ReferenceType: derived

ReferenceCitation: Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

status: Terminated

title: Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

primary_purpose: Treatment

type: EudraCT Number

type: Other Identifier

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Argentina
Hong Kong
Japan
Austria
Belgium
United States
Greece
Canada
Ukraine
Puerto Rico
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Unknown


acronym: PROLONG

intervention_type: Other

summary: The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

location_country:
Finland
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Ukraine
India
Belgium
Puerto Rico
Italy
Norway
Sweden
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: Attain Success Clinical Trial

summary: The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
Poland
India
Hong Kong
Romania
Singapore
Malta
United States
China
Thailand
Malaysia
Pakistan
Taiwan
Canada
Puerto Rico
France

intervention_type: Device

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation

summary: The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.

enrollment_type: Anticipated

ReferenceCitation: Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.

lead_sponsor: Bausch Health Americas, Inc.

location_country: Germany Sweden Netherlands Austria Belgium Spain France

location_facility: Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt

location_facility: Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus

location_facility: Hospital Universitario Fundacion Alcordon

location_facility: Academic Medical Center, Depart. of Urology

location_facility: Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32

location_facility: Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf

location_facility: CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques,

location_facility: Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e

location_facility: Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10

location_facility: PUR/R Praxisklinik Urologie 3 Rhein Ruhr

location_facility: Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt


acronym: PREDICT

intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: The objective of this study is to evaluate the clinical activity of the GSK2132231A immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma presenting with the predictive gene signature.

ReferenceType: background

ReferenceCitation: Saiag P, Gutzmer R, Ascierto PA, Maio M, Grob JJ, Murawa P, Dreno B, Ross M, Weber J, Hauschild A, Rutkowski P, Testori A, Levchenko E, Enk A, Misery L, Vanden Abeele C, Vojtek I, Peeters O, Brichard VG, Therasse P. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT). Ann Oncol. 2016 Oct;27(10):1947-53. doi: 10.1093/annonc/mdw291. Epub 2016 Aug 8.

title: GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

design_allocation: Non-Randomized

location_country:
Ireland
Italy
Germany
Poland
United States
Spain
Russian Federation
France


title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

acronym: BRISK TA

summary: The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Argentina
Hong Kong
Australia
Japan
United States
China
Korea, Republic of
Spain
Thailand
Taiwan
Canada
France

location_facility: The University Of Texas MD Anderson Cancer Center


lead_sponsor: Pfizer

summary: The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

location_country:
Finland
Germany
Italy
Hungary
United Kingdom
Denmark
Romania
Sweden
Netherlands
Austria
Belgium
Spain
Greece
France


type: U.S. NIH Grant/Contract

title: Strategic Timing of AntiRetroviral Treatment

acronym: START

summary:
Objectives:

To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

ReferenceCitation: Babiker AG, Emery S, Fatkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.

ReferenceType: result

ReferenceCitation: INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;www.arca.fiocruz.br

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Gabrielaite M, Bennedbaek M, Zucco AG, Ekenberg C, Murray DD, Kan VL, Touloumi G, Vandekerckhove L, Turner D, Neaton J, Lane HC, Safo S, Arenas-Pinto A, Polizzotto MN, Gunthard HF, Lundgren JD, Marvig RL. Human Immunotypes Impose Selection on Viral Genotypes Through Viral Epitope Specificity. J Infect Dis. 2021 Dec 15;224(12):2053-2063. doi: 10.1093/infdis/jiab253.

oa_host_type: repository

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ReferenceCitation: Ghazi L, Baker JV, Sharma S, Jain MK, Palfreeman A, Necsoi C, Murray DD, Neaton JD, Drawz PE. Role of Inflammatory Biomarkers in the Prevalence and Incidence of Hypertension Among HIV-Positive Participants in the START Trial. Am J Hypertens. 2020 Jan 1;33(1):43-52. doi: 10.1093/ajh/hpz132.

evidence: open (via free pdf)

repositories_concat: PubMed Central

ReferenceCitation: Lampe FC, Rodger AJ, Burman W, Grulich A, Friedland G, Sadr WE, Neaton J, Corbelli GM, Emery S, Molina JM, Orkin C, Gatell J, Gerstoft J, Ruxrungtham K, Barbosa de Souza M, Phillips AN; INSIGHT START Study Group. Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison. AIDS. 2019 Dec 1;33(15):2337-2350. doi: 10.1097/QAD.0000000000002359.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories:
PubMed Central
Pure (Denmark)
pure.ed.ac.uk

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Wyman Engen N, Huppler Hullsiek K, Belloso WH, Finley E, Hudson F, Denning E, Carey C, Pearson M, Kagan J. A randomized evaluation of on-site monitoring nested in a multinational randomized trial. Clin Trials. 2020 Feb;17(1):3-14. doi: 10.1177/1740774519881616. Epub 2019 Oct 24.

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Sharma S, Baker JV, Collins S, Mannheimer S, Pett S, Touzeau-Romer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT START Study Group. Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study. J Int AIDS Soc. 2019 Jun;22(6):e25297. doi: 10.1002/jia2.25297.

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery

ReferenceCitation: Borges AH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.

ReferenceCitation: Molina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16.

ReferenceCitation: Ronit A, Sharma S, Baker JV, Mngqibisa R, Delory T, Caldeira L, Ndembi N, Lundgren JD, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Strategic Timing of Antiretroviral Treatment (START) Study Group. Serum Albumin as a Prognostic Marker for Serious Non-AIDS Endpoints in the Strategic Timing of Antiretroviral Treatment (START) Study. J Infect Dis. 2018 Jan 17;217(3):405-412. doi: 10.1093/infdis/jix350.

ReferenceCitation: Baker JV, Sharma S, Achhra AC, Bernardino JI, Bogner JR, Duprez D, Emery S, Gazzard B, Gordin J, Grandits G, Phillips AN, Schwarze S, Soliman EZ, Spector SA, Tambussi G, Lundgren J; INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of Antiretroviral Treatment) Study Group. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial. J Am Heart Assoc. 2017 May 22;6(5):e004987. doi: 10.1161/JAHA.116.004987.

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery
dnet
epub.ub.uni-muenchen.de

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery;dnet;epub.ub.uni-muenchen.de

repositories_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

ReferenceCitation: Grady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, Pantazis N, Tavel J, Florence E, Sanchez A, Hudson F, Papadopoulos A, Emanuel E, Clewett M, Munroe D, Denning E; INSIGHT START Informed Consent Substudy Group. A randomized trial comparing concise and standard consent forms in the START trial. PLoS One. 2017 Apr 26;12(4):e0172607. doi: 10.1371/journal.pone.0172607. eCollection 2017.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: O'Connor J, Vjecha MJ, Phillips AN, Angus B, Cooper D, Grinsztejn B, Lopardo G, Das S, Wood R, Wilkin A, Klinker H, Kantipong P, Klingman KL, Jilich D, Herieka E, Denning E, Abubakar I, Gordin F, Lundgren JD; INSIGHT START study group. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per muL: secondary outcome results from a randomised controlled trial. Lancet HIV. 2017 Mar;4(3):e105-e112. doi: 10.1016/S2352-3018(16)30216-8. Epub 2017 Jan 5.

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

ReferenceCitation: Carr A, Grund B, Neuhaus J, Schwartz A, Bernardino JI, White D, Badel-Faesen S, Avihingsanon A, Ensrud K, Hoy J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Prevalence of and risk factors for low bone mineral density in untreated HIV infection: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):137-46. doi: 10.1111/hiv.12242.

ReferenceCitation: Matthews GV, Neuhaus J, Bhagani S, Mehta SH, Vlahakis E, Doroana M, Naggie S, Arenas-Pinto A, Peters L, Rockstroh JK; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline prevalence and predictors of liver fibrosis among HIV-positive individuals: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:129-36. doi: 10.1111/hiv.12241.

ReferenceCitation: Kunisaki KM, Niewoehner DE, Collins G, Nixon DE, Tedaldi E, Akolo C, Kityo C, Klinker H, La Rosa A, Connett JE; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Pulmonary function in an international sample of HIV-positive, treatment-naive adults with CD4 counts > 500 cells/muL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):119-28. doi: 10.1111/hiv.12240.

ReferenceCitation: Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.

ReferenceCitation: Wright EJ, Grund B, Cysique LA, Robertson KR, Brew BJ, Collins G, Shlay JC, Winston A, Read TR, Price RW; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Factors associated with neurocognitive test performance at baseline: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:97-108. doi: 10.1111/hiv.12238.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Lifson AR, Grandits GA, Gardner EM, Wolff MJ, Pulik P, Williams I, Burman WJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Quality of life assessment among HIV-positive persons entering the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):88-96. doi: 10.1111/hiv.12237.

ReferenceCitation: Baxter JD, Dunn D, White E, Sharma S, Geretti AM, Kozal MJ, Johnson MA, Jacoby S, Llibre JM, Lundgren J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):77-87. doi: 10.1111/hiv.12236.

ReferenceCitation: Rodger AJ, Lampe FC, Grulich AE, Fisher M, Friedland G, Phanuphak N, Bogner JR, Pereira LC, Rietmeijer C, Burman W, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Transmission risk behaviour at enrolment in participants in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):64-76. doi: 10.1111/hiv.12235.

ReferenceCitation: Achhra AC, Mocroft A, Ross MJ, Ryom L, Lucas GM, Furrer H, Neuhaus J, Somboonwit C, Kelly M, Gatell JM, Wyatt CM; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Kidney disease in antiretroviral-naive HIV-positive adults with high CD4 counts: prevalence and predictors of kidney disease at enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):55-63. doi: 10.1111/hiv.12234.

ReferenceCitation: Soliman EZ, Sharma S, Arasteh K, Wohl D, Achhra A, Tambussi G, O'Connor J, Stein JH, Duprez DA, Neaton JD, Phillips A; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):46-54. doi: 10.1111/hiv.12233.

ReferenceCitation: Law MG, Achhra A, Deeks SG, Gazzard B, Migueles SA, Novak RM, Ristola M; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Clinical and demographic factors associated with low viral load in early untreated HIV infection in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):37-45. doi: 10.1111/hiv.12232.

ReferenceCitation: Sharma S, Babiker AG, Emery S, Gordin FM, Lundgren JD, Neaton JN, Bakowska E, Schechter M, Wiselka MJ, Wolff MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):30-6. doi: 10.1111/hiv.12231.

ReferenceCitation: Denning E, Sharma S, Smolskis M, Touloumi G, Walker S, Babiker A, Clewett M, Emanuel E, Florence E, Papadopoulos A, Sanchez A, Tavel J, Grady C; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):24-9. doi: 10.1111/hiv.12230.

ReferenceCitation: Grarup J, Rappoport C, Engen NW, Carey C, Hudson F, Denning E, Sharma S, Florence E, Vjecha MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Challenges, successes and patterns of enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(Suppl Suppl 1):14-23. doi: 10.1111/hiv.12229.

ReferenceCitation: Geffen N, Aagaard P, Corbelli GM, Meulbroek M, Peavy D, Rappoport C, Schwarze S, Collins S; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board. Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):10-3. doi: 10.1111/hiv.12228.

ReferenceCitation: INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group; Lundgren J, Babiker A, Gordin F, Emery S, Fatkenheuer G, Molina JM, Wood R, Neaton JD. Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):1-9. doi: 10.1111/hiv.12227. No abstract available.

ReferenceCitation: Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.

collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

collaborators: Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark

collaborators: The Kirby Institute for Infection and Immunity in Society

collaborators: Washington D.C. Veterans Affairs Medical Center

collaborators: German Federal Ministry of Education and Research

collaborators: National Health and Medical Research Council, Australia

collaborators: National Institutes of Health Clinical Center (CC)

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

collaborators: National Institute of Mental Health (NIMH)

collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

sponsor_collaborators: Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark

sponsor_collaborators: The Kirby Institute for Infection and Immunity in Society

sponsor_collaborators: Washington D.C. Veterans Affairs Medical Center

sponsor_collaborators: German Federal Ministry of Education and Research

sponsor_collaborators: National Health and Medical Research Council, Australia

sponsor_collaborators: National Institutes of Health Clinical Center (CC)

sponsor_collaborators: National Heart, Lung, and Blood Institute (NHLBI)

sponsor_collaborators: National Institute of Mental Health (NIMH)

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Mali
Thailand
Luxembourg
Chile
Czechia
France
Portugal
Nigeria
Denmark
Switzerland
United States
Morocco
Uganda
India
Belgium
Malaysia
Peru
Estonia
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Spain
Greece
South Africa
Israel

location_facility: Faculty Hospital Na Bulovce, Prague, Czech Rep.

location_facility: Durban International Clinical Research Site

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: University of Puerto Rico Pediatric Research Site

location_facility: Institute of Human Virology-Nigeria (IHVN)

location_facility: Newland Immunology Center of Excellence (NICE)

location_facility: Center for Infectious Diseases at the UFES

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Infectious Diseases Associates NW FL, PA

location_facility: George Washington Medical Faculty Associates

location_facility: Helsinki University Central Hospital, Div. of Infectious Diseases CRS

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Guy's and St.Thomas' NHS Foundation Trust

location_facility: Centro de Referencia e Treinamento DST/Aids

location_facility: EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH

location_facility: Desmond Tutu HIV Foundation Clinical Trials Unit

location_facility: Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)

location_facility: Walter Reed National Military Medical Center

location_facility: Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

location_facility: Centre Hospitalier - H�pital Gustave Dron

location_facility: Coventry and Warwickshire NHS partnership Trust

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: The Ohio State University Medical Center

location_facility: Rigshospitalet, Infektionsmedicinsk ambulatorium 8622

location_facility: Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of North Texas Health Science Center

location_facility: SEI - Servi�os Especializados em Infectologia

location_facility: National Institutes of Health Clinical Center

location_facility: Sheffield Teaching Hospital NHS Foundation Trust

location_facility: University of Florida Health Services Center

location_facility: Florida Department of Health in Orange County/Sunshine Care Center

location_facility: Asociacion Civil IMPACTA Salud y Educacion

location_facility: Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS

location_facility: CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie

location_facility: Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)

location_facility: Hospital Escola Sao Francisco de Assis - UFRJ

location_facility: INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)

location_facility: Research Institute for Health Sciences (RIHES)

location_facility: Community Research Initiative of New England

location_facility: West Tallinn Central Hospital Infectious Diseases

location_facility: Hospital Interzonal General de Agudos Dr. Diego Paroissien

location_facility: Durban International Clinical Research Site (WWH)

location_facility: The Research + Education Group - Portland

location_facility: University College London Medical School

location_facility: Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hillsborough County Health Deptment/University of South Florida

location_facility: Otto-Wagner-Spital SMZ /Baumgartner Hoehe

location_facility: Belfast Health and Social Care Trust (RVH)

location_facility: New Jersey Medical School Adult Clinical Research Center

location_facility: Sexual Health and HIV Service - Clinic 2

location_facility: Instituto de Infectologia Emilio Ribas - IIER

location_facility: Hospital General de Agudos JM Ramos Mejia

location_facility: Khon Kaen University, Srinagarind Hospital

location_facility: The Research and Education Group at Portland VA Research Foundation

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS

location_facility: Hospital Universitario Principe de Asturias

location_facility: Hvidovre University Hospital, Department of Infectious Diseases

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Hippokration University General Hospital of Athens


title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

ReferenceCitation: Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.

ReferenceCitation: Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.

ReferenceCitation: Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.

ReferenceCitation: Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.

ReferenceCitation: Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.

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

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Morocco
Ukraine
India
Romania
Tunisia
Belgium
China
Malaysia
Egypt
Philippines
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel


lead_sponsor: H. Lundbeck A/S

summary: The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

ReferenceCitation: Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Gronning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.

title: A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

location_country:
Germany
Poland
India
Hong Kong
Singapore
Australia
Netherlands
Austria
Switzerland
Korea, Republic of
Spain
Thailand
Vietnam
Taiwan
Estonia
Philippines
France


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)

summary: The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

ReferenceCitation: Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foa R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.

lead_sponsor: Celgene

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Russian Federation
Israel

location_facility: Charite, Campus Benjamin Franklin, Medizinische Klinik III

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Hopital Petie- SalpetriereDepartment d'Hematologie

location_facility: Wilgers Oncology CentreWilgrers Hospital

location_facility: Drexel University, College of Medicine, Clinical Research Group

location_facility: Istituto dei Tumori Giovanni Paolo II di Bari

location_facility: Abington Hematology Oncology Associates Inc

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: SUNY Upstate Medical University Medicine Oncology

location_facility: Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital

location_facility: Azienda Ospedaliera Vittorio Emanuele-Ferrarotto

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: St. Petersburg Pavlov State Medical Univ

location_facility: Florida Hospital Cancer Institute Waterman

location_facility: University Hospitals Cleveland Medical Center

location_facility: Haematology and Oncology Clinics of Australasia

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: State Budgetary Institution of the City of Moscow

location_facility: Royal North Shore HospitalDepartment of HematologyLevel 4

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: State Healthcare Institution Sverdlovsk regional clinical hospital 1

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Northwestern University, Division of Hematology Oncology, Dept. of Medicine

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: Biomedical Research Alliance of New York, LLC

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Clinical Trials Unit The St George Hospital

location_facility: CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Singleton Hospital, Southwest Wales Cancer Inst

location_facility: Azienda Ospedaliero Universitaria OORR Foggia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: General Faculty Hosital1.Internal Clinic

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Innere Medizin Klinikum Frankfurt Oder GmBH

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: GUZ Volgograd Regional Clinical Oncology

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

location_facility: FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE


title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

location_country:
Germany
Italy
Poland
Hungary
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Texas Oncology Cancer Care Center & Research Center

location_facility: University of California Irvine Medical Center

location_facility: Mamie McFadden Ward Cancer Ctr, Texas Oncology

location_facility: Central Hematology Oncology Medical Group

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Palo Alto Medical Foundation - Camino Div.

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Ventura County Hematology/Oncology Specialists

location_facility: California Pacific Medical Research Institute

location_facility: Hematology/Oncology Associates of Treasure Coast


summary: To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

ReferenceCitation: Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

sponsor_collaborators:
Novartis Pharmaceuticals
Roche Pharma AG

location_facility: Las Colinas Hematology Oncology Grapevine

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)

location_facility: University of California at Los Angeles Dept. of Hem/Oncology

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: Seattle Cancer Care Alliance Dept. of SCCA

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: Nevada Cancer Institute Dept. of Nevada Cancer (3)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

title: A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

location_country:
Germany
Brazil
Thailand
Turkey
France
Czech Republic
Hungary
Hong Kong
Switzerland
United States
Belgium
Egypt
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Hong Kong
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Peninsula Regional Oncology and Hematology

location_facility: Allegheny General Hospital/Allegheny Cancer Center

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: Alamance Regional Medical Center-Cancer Ctr.

location_facility: Rochester General Hospital - Lipson Cancer Center

location_facility: University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center

location_facility: Kansas City Veterans Affair Medical Center

location_facility: Pacific Oncology and Hematology Association

location_facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health

location_facility: Illinois Oncology/Warren Billhartz Cancer Ctr.

location_facility: University of South Alabama/Mitchell Cancer Institute

location_facility: Hematology Oncology Associates of Rockland

location_facility: Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center

location_facility: Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program

location_facility: Medical College of Wisconsin/Division of Neoplastic & Related Disorders

location_facility: Siouxland Hematology-Oncology Assoc., LLC

location_facility: Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc

location_facility: University of California Irvine Comprhensive Center

location_facility: St. Luke's Hospital - St Luke's Cancer Center

location_facility: Cleo Craig Memorial Cancer Ctr. & Research Clinic

location_facility: Advocate Illinois Masonic Medical Center

location_facility: Providence Everett Medical Center/Providence regional Cancer Partnership

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Center for Cancer Care and Research (US Oncology)

location_facility: Loyola Cancer Care & Research Ctr. at Central Dupage Hospital

location_facility: Medical Oncology & Hematology Associates of Northern Virginia

location_facility: Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute

location_facility: Texas Oncology Cancer Center of the High Plains

location_facility: Osteopathic Medical Oncology and Hematology PC

location_facility: University of Oklahoma Health Science Center

location_facility: University of Louisville - James Graham Brown Cancer Center


title: A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

ReferenceCitation: Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
New Zealand
Australia
Chile
Canada
France
Czech Republic
Lithuania
Slovenia
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Venezuela
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Russian Federation


acronym: ALTITUDE

summary:
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

ReferenceCitation: Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Linkoping University - DiVA

repository_institution: The University of Glasgow - Enlighten: Publications

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Heerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.

ReferenceCitation: Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.

ReferenceCitation: Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92.

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

location_country:
Finland
Germany
Argentina
Japan
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Peru
Puerto Rico
Italy
Guatemala
Norway
Singapore
United Kingdom
Venezuela
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Sweden


title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

summary: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

ReferenceCitation: Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

ReferenceCitation: Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

location_country:
Germany
Poland
Australia
Brazil
Pakistan
Canada
France
Czech Republic
Slovakia
United States
Ukraine
India
Romania
Belgium
Puerto Rico
Egypt
Italy
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit

acronym: MIDEX

summary:
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Midazolam is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation)

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study, dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam.

in this study we hope to show that: dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable, and that they are able to co-operate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.

ReferenceCitation: Turunen H, Jakob SM, Ruokonen E, Kaukonen KM, Sarapohja T, Apajasalo M, Takala J. Dexmedetomidine versus standard care sedation with propofol or midazolam in intensive care: an economic evaluation. Crit Care. 2015 Feb 19;19(1):67. doi: 10.1186/s13054-015-0787-y.

repository_institution: University of Bern - Bern Open Repository and Information System

repositories_concat: PubMed Central;boris.unibe.ch

ReferenceCitation: Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
Germany
Norway
United Kingdom
Netherlands
Switzerland
Belgium
Estonia
France

location_facility: Kantonsspital Winterthur, Brauerstrasse 15,

location_facility: Centre Hospitalier Universitaire d'Orleans, Reanimation Medicale, 1, rue Prote Madeleine, BP 2439

location_facility: Amphia Ziekenhuis, Dept. Intensieve Zorgen, Molengracht 21

location_facility: Centre Hospitalier Universitaire de Grenoble, Service de Reanimation Medicale, Boulevard de la Chantourne, BP 217

location_facility: Isala Klinieken, Locatie Weezenlanden, Groot Wezenland 20

location_facility: Haukeland University Hospital, Intensive Care Unit, Jonas Liesvei 65

location_facility: Universitatsklinikum Bonn, Klinik u. Poliklinik f. Anasthesiologie u. Operative Intensivmedizin, Sigmund-Freud-Strasse 25

location_facility: Rikshospitalet, Universitetsklinikk, Sognsvannsveien 20

location_facility: Birmingham Heartlands Hospital, Bordesely Green East

location_facility: CHU de Liege (Sart Tilman), Domaine de Sart-Tilman

location_facility: Oulu University Hospital, Kajaanintie 50

location_facility: Aker Universtetssykehus HF, Anestesiavdelingen, Trondheimsveien 235

location_facility: Hopital Foch, Service Renimation, 40 Rue Worth, Suresnes Hauts de Seine

location_facility: Albert Schweitzer Hospital, Locatie Dordwikj, Albert Schweitzerplaats 25

location_facility: Hopital Albert Calmette, Boulevard Du Pr. Jules Leclercq

location_facility: Viecuri MC voor Noord-Limburg, Locatie Venlo, Dept. Intensieve Zorgen, Tegelseweg 210

location_facility: Centre Hospitalier Universitaire Limoges Hopital Dupuytren, Service de Reanimation Polyvalente, 2, Avenue Martin Luther King

location_facility: Tartu University Hospistal, Clinic of Anesthesiology and Intensive Care, L. Puusepa 8

location_facility: Universitaer Ziekenhuis Gent, Intensieve Zorgen, De Pintelaan 185

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul, Service de Reanimation Medicale, 27 Rue du Faubourg Saint Jacques

location_facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau Service Reanimation Medicale Polyvalente, 2, Boulevard Tonnelle, Tours cedex 9

location_facility: University Hospital Birmingham, Department of Anaesthesia, Queen Elizabeth Hospital,

location_facility: UZ Brussel, Intensive Care Dept. Laarbeeklaan 101

location_facility: Centre Hospitalier La Roche sur Yon CHD les Oudaireis, Service Reanimation CHD la Roche sur Yon, Les Oudairies

location_facility: Centre Hospitalier Universitaire d'Angers, Reanimation medicale est de Mededicne Hyperbare, 4 Rue Larrey

location_facility: Centre Hospitalier Universitaire de Poitiers, Reanimation Medicale, 2, Rue de la Miletrie

location_facility: North Estonian Regional Hospital, Centre of Intensive Care, J. Sutiste Tee 18

location_facility: Universitatsklinikum Greifswald, Klinik u. Poliklinik f. Anasthesiologie u. Intensivmedizin, Friedrich-Loeffler-Str. 23b

location_facility: Ulleval University Hospital, Medical and Surgical ICU, Kirkeveien 166

location_facility: East Tallinn Central Hospital, Ravi Stret 18

location_facility: North Estonian Regional Hospital, Dept. of Postoperative Intensive Care, J. Sutiste Tee 18

location_facility: Hopital Bichat-Claude, Dept. D'Anasehesie et Reanimation Chirurgicale, 46, rue Henri-Huchard

location_facility: Saint Elisabeth Ziekenhuis, Dept. Intensieve Zorgen, Hilvarenbeekseweg 60

location_facility: Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin, Hoppe-Seyler-Strasse 3

location_facility: Gelre Hospitals - Locatie Lucas, A.Schweitzerlaan 32

location_facility: Universitatsspital Zurich, Klinik fur Innere Medizin, Intensivstation, Ramistrasse 100

location_facility: Centre Hospitalier Victor Dupouy Hopital Dupuytren, Service Reanimation Polyvalente, 69, Rue du Lt Colonel Prud'hon

location_facility: Derriford Hospital, Dept. of Intensive Care Level 4, Derriford Road


title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

acronym: ADOPT

summary: The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

primary_purpose: Prevention

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

publisher_dissemination: Informa

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Colombia
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Belgium
Malaysia
Peru
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: The Milton S Hershey Medical Center Of Penn. State Univ.

location_facility: Michael E. De Bakey Veteran Affairs Medical Center

location_facility: Jacksonville Center For Clinical Research

location_facility: Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

location_facility: Johns Hopkins University School Of Medicine

location_facility: University Of Alabama At Birmingham Hospital

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Scripps Clinic/Scripps Health And Green Hospital


title: Safety and Antiviral Activity of TPV in Hepatitis C or Hepatitis B HIV Coinfected Patients - TDM Randomised Pilot Evaluation

summary: The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Argentina
Brazil
United States
Spain
France

location_facility: 1182.99.3304A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310D Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3304C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310F Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55003 Centro de Referência e Treinamento - DST/AIDS

location_facility: 1182.99.3906 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.1 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.32 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55001 Universidade Federal de Sao Paulo

location_facility: 1182.99.4909 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.4 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310E Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306G Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310H Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3301A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306K Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55004 Unidade de Referência em doenças Infecciosas Preveníveis

location_facility: 1182.99.3302A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.12 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3911 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.31 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310G Boehringer Ingelheim Investigational Site


title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

ReferenceCitation: Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.

ReferenceCitation: Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

ReferenceCitation: Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.

lead_sponsor: Novartis

location_country:
Germany
Argentina
Turkey
Chile
France
Czech Republic
Lithuania
Colombia
Slovakia
Hungary
Denmark
Switzerland
Latvia
Romania
Peru
Estonia
Egypt
Italy
Ecuador
United Kingdom
Netherlands
Korea, Republic of
Spain
Russian Federation
Israel

location_facility:
Novartis Investigative Site
Novartis Investigator Site
Novartis


title: Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study

acronym: SOLAR

summary: This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

ReferenceCitation: Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma Europe B.V.

location_country:
Italy
Poland
Hungary
Australia
Netherlands
Belgium
Spain
Turkey
Czech Republic
Russian Federation
France


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

summary: This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

ReferenceCitation: Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.

location_country:
Finland
Germany
Italy
United Kingdom
Japan
Sweden
Austria
United States
Spain
France

location_facility: 248.595.0113 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306B Centre Hospitalier du Pays d'Aix

location_facility: 248.595.0136 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0108 Boehringer Ingelheim Investigational Site

location_facility: 248.595.81002 Kagawa Prefectural Central Hospital

location_facility: 248.595.0115 Boehringer Ingelheim Investigational Site

location_facility: 248.595.81001 Juntendo University Hospital

location_facility: 248.595.39011 Ospedale S. Raffaele - IRCCS

location_facility: 248.595.35804 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34002 Nuevo Hospital de Sant Pau

location_facility: 248.595.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa

location_facility: 248.595.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0114 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306C Centre Hospitalier du Pays d'Aix

location_facility: 248.595.0139 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34001 Hospital Clinic i Provincial of Barcelona

location_facility: 248.595.46007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0133 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0140 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0122 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0141 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39006 Policlinico Universitario Molinette

location_facility: 248.595.0104 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0119 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0121 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0109 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0123 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39007 Ospedale Evangelico Valdese

location_facility: 248.595.39004 Università degli Studi di Bari

location_facility: 248.595.34005 Hospital Mutua de Terrassa

location_facility: 248.595.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0131 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0129 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0111 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0118 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0116 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento

location_facility: 248.595.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena

location_facility: 248.595.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0103 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0120 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0137 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0127 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0134 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0107 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0105 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39005 Ospedale della Misericordia

location_facility: 248.595.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0112 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0106 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0102 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306A Centre Hospitalier du Pays d'Aix

location_facility: 248.595.46004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0124 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0101 Boehringer Ingelheim Investigational Site


title: Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

summary: The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

ReferenceCitation: Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

publisher_dissemination: Springer

ReferenceCitation: Heading RC, Monnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.

lead_sponsor: Takeda

location_country:
Germany
Poland
Argentina
Australia
Brazil
Canada
France
Portugal
Hong Kong
Switzerland
India
Belgium
Malaysia
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan


title: A Randomized, Controlled Trial to Evaluate the Effects of Nadroparin on Survival and Disease Progression in Patients With Advanced Malignancies of the Lung, Pancreas, or Prostate

summary: This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).

ReferenceCitation: van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18.

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:
Germany
Italy
Poland
Slovenia
Hungary
Netherlands
Belgium
Canada
Czech Republic
Russian Federation
France