title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks

summary: This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

ReferenceCitation: Mohler ER 3rd, Ballantyne CM, Davidson MH, Hanefeld M, Ruilope LM, Johnson JL, Zalewski A; Darapladib Investigators. The effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity and cardiovascular biomarkers in patients with stable coronary heart disease or coronary heart disease risk equivalent: the results of a multicenter, randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 2008 Apr 29;51(17):1632-41. doi: 10.1016/j.jacc.2007.11.079.

family: Mohler

full_name: Emile R. Mohler

given: Emile R.

suffix: III

family: Ballantyne

full_name: Christie M. Ballantyne

given: Christie M.

family: Davidson

full_name: Michael H. Davidson

given: Michael H.

family: Hanefeld

full_name: Markolf Hanefeld

given: Markolf

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

family: Johnson

full_name: Joel L. Johnson

given: Joel L.

family: Zalewski

full_name: Andrew Zalewski

given: Andrew

journal_name: Journal of the American College of Cardiology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The Effect of Darapladib on Plasma Lipoprotein-Associated Phospholipase A2 Activity and Cardiovascular Biomarkers in Patients With Stable Coronary Heart Disease or Coronary Heart Disease Risk Equivalent

location_country:
United States
India
Netherlands
Germany
Pakistan
France
Bulgaria
Romania
Hungary
Argentina
Australia
New Zealand
Spain
Estonia
Denmark
Canada


title: Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

summary: The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.

family: Marcus

full_name: Ronald Marcus

given: Ronald

sequence: first

family: Khan

full_name: Arif Khan

given: Arif

sequence: additional

family: Rollin

full_name: Linda Rollin

given: Linda

family: Morris

full_name: Beth Morris

given: Beth

family: Timko

full_name: Karen Timko

given: Karen

family: Carson

full_name: William Carson

given: William

family: Sanchez

full_name: Raymond Sanchez

given: Raymond

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Bipolar Disorders

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Brazil
South Africa
India
Croatia
Bulgaria
France
Russian Federation
United States
Czech Republic

location_facility: University Of Massachusetts Medical School

location_facility: Psychopharmacology Research Network Of Torrance

location_facility: Behavioral Medical Research Of Staten Island

location_facility: University Of California, Irvine Medical Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

ReferenceCitation: Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.

family: Friedlander

full_name: Philip Friedlander

given: Philip

family: Wood

full_name: Kevin Wood

given: Kevin

family: Wassmann

full_name: Karl Wassmann

given: Karl

family: Christenfeld

full_name: Alan M. Christenfeld

given: Alan M.

family: Bhardwaj

full_name: Nina Bhardwaj

given: Nina

family: Oh

full_name: William K. Oh

given: William K.

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.

name: Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center,...

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Kefford

full_name: Richard Kefford

given: Richard

family: Marshall

full_name: Margaret A. Marshall

given: Margaret A.

family: Punt

full_name: Cornelis J.A. Punt

given: Cornelis J.A.

family: Haanen

full_name: John B. Haanen

given: John B.

family: Marmol

full_name: Maribel Marmol

given: Maribel

family: Garbe

full_name: Claus Garbe

given: Claus

family: Gogas

full_name: Helen Gogas

given: Helen

family: Schachter

full_name: Jacob Schachter

given: Jacob

family: Linette

full_name: Gerald Linette

given: Gerald

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

location_country:
Greece
Australia
Belgium
Russian Federation
France
Poland
Slovakia
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Mexico
Israel
Spain


title: FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

acronym: FACT

summary: The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

lead_sponsor: AstraZeneca

location_country:
Italy
Sweden
Guatemala
Costa Rica
Finland
France
Norway
Portugal
Turkey
Germany
Canada
Iceland


title: A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Omiganan 1% Gel in Preventing Local Catheter Site Infections/Colonization in Patients Undergoing Central Venous Catheterization

summary: The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.

primary_purpose: Prevention

lead_sponsor: Cadence Pharmaceuticals

location_country:
Germany
United States
France
Spain


title: The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

acronym: EXTEND

summary: This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

status: Terminated

ReferenceCitation: Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.

family: Agnelli

full_name: G. Agnelli

given: G.

family: Eriksson

full_name: B.I. Eriksson

family: Cohen

full_name: A.T. Cohen

family: Bergqvist

full_name: D. Bergqvist

given: D.

family: Dahl

full_name: O.E. Dahl

family: Lassen

full_name: M.R. Lassen

family: Mouret

full_name: P. Mouret

given: P.

family: Rosencher

full_name: N. Rosencher

given: N.

family: Andersson

full_name: M. Andersson

given: M.

family: Bylock

full_name: A. Bylock

given: A.

family: Jensen

full_name: E. Jensen

given: E.

family: Boberg

full_name: B. Boberg

given: B.

journal_name: Thrombosis Research

title: Safety assessment of new antithrombotic agents: Lessons from the EXTEND study on ximelagatran

location_country:
Austria
South Africa
Sweden
Switzerland
Mexico
Netherlands
Spain
Finland
France
Poland
Norway
Hungary
Belgium
Portugal
Denmark
Germany

status_simplified: Unknown


type: Other Identifier

title: Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

summary:
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D; BENEFIT Study Group. Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1183-9. doi: 10.1136/jnnp-2013-306222. Epub 2013 Nov 11.

ReferenceCitation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

name: Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands

family: Nagtegaal

full_name: Gijsbert JA Nagtegaal

given: Gijsbert JA

name: Global Clinical Development, Bayer Pharma AG, Germany

name: Department of Neurology, University Hospital of Bonn, Germany

family: Pohl

full_name: Christoph Pohl

given: Christoph

family: Wattjes

full_name: Mike P Wattjes

given: Mike P

family: Hulst

full_name: Hanneke E Hulst

given: Hanneke E

name: Department of Medicine, Ottawa Hospital Research Institute, Canada

family: Freedman

full_name: Mark S Freedman

given: Mark S

name: Neurology Clinic, Heinrich-Heine-Universität, Germany

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

name: Institute of Neurology, National Hospital for Neurology and Neurosurgery, UK

family: Miller

full_name: David Miller

given: David

name: MS Centre of Catalonia, Hospital Vall d’Hebron, Spain

family: Montalban

full_name: Xavier Montalban

given: Xavier

name: Department of Neurology, University of Basel and University Hospital, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Service de Neurologie, Université of Rennes, France

family: Edan

full_name: Gilles Edan

given: Gilles

name: Global Medical Affairs, Bayer HealthCare Pharmaceuticals, USA

family: Pleimes

full_name: Dirk Pleimes

given: Dirk

family: Beckman

full_name: Karola Beckman

given: Karola

family: Stemper

full_name: Brigitte Stemper

given: Brigitte

family: Polman

full_name: Christoph H Polman

given: Christoph H

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

journal_name: Multiple Sclerosis Journal

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Penner IK, Stemper B, Calabrese P, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Pleimes D, Lanius V, Pohl C, Kappos L, Sandbrink R. Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis. Mult Scler. 2012 Oct;18(10):1466-71. Epub 2012 Apr 4.

ReferenceType: result

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Radü EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.

full_name: Chris H Polman

given: Chris H

ReferenceCitation: Hartung HP, Freedman MS, Polman CH, Edan G, Kappos L, Miller DH, Montalbán X, Barkhof F, Petkau J, White R, Sahajpal V, Knappertz V, Beckmann K, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Interferon β-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology. 2011 Aug 30;77(9):835-43. doi: 10.1212/WNL.0b013e31822c90d7. Epub 2011 Aug 17. Erratum in: Neurology. 2011 Sep 27;77(13):1317.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Interferon -1b-neutralizing antibodies 5 years after clinically isolated syndrome

ReferenceCitation: Freedman MS, Metzig C, Kappos L, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Yarden J, Spector L, Fire E, Dotan N, Schwenke S, Lanius V, Sandbrink R, Pohl C. Predictive nature of IgM anti-α-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis. Mult Scler. 2012 Jul;18(7):966-73. doi: 10.1177/1352458511432327. Epub 2011 Dec 19.

name: Multiple Sclerosis Research Clinic, The Ottawa Hospital – General Campus, Ottawa, Ontario, Canada

name: Department of Neurology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands

name: Neurological Department, Clinique Neurologique, Rennes, France

name: Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany

name: Department of Neuroinflammation, Institute of Neurology, University College London, London, UK

name: Unit of Clinical Neuroimmunology, Hospitals Vall d’Hebron, Barcelona, Spain

ReferenceCitation: Waschbisch A, Sandbrink R, Hartung HP, Kappos L, Schwab S, Pohl C, Wiendl H. Evaluation of soluble HLA-G as a biomarker for multiple sclerosis. Neurology. 2011 Aug 9;77(6):596-8. doi: 10.1212/WNL.0b013e318228c14d. Epub 2011 Jul 27.

ReferenceCitation: Moraal B, Pohl C, Uitdehaag BM, Polman CH, Edan G, Freedman MS, Hartung HP, Kappos L, Miller DH, Montalban X, Lanius V, Sandbrink R, Barkhof F. Magnetic resonance imaging predictors of conversion to multiple sclerosis in the BENEFIT study. Arch Neurol. 2009 Nov;66(11):1345-52. doi: 10.1001/archneurol.2009.243.

title: Magnetic Resonance Imaging Predictors of Conversion to Multiple Sclerosis in the BENEFIT Study

ReferenceCitation: Polman C, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Selmaj K, Uitdehaag BM, Dahms S, Bauer L, Pohl C, Sandbrink R; BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol. 2008 Apr;255(4):480-7. Epub 2007 Nov 15.

ReferenceCitation: Caloyeras JP, Zhang B, Wang C, Eriksson M, Fredrikson S, Beckmann K, Knappertz V, Pohl C, Hartung HP, Shah D, Miller JD, Sandbrink R, Lanius V, Gondek K, Russell MW. Cost-effectiveness analysis of interferon beta-1b for the treatment of patients with a first clinical event suggestive of multiple sclerosis. Clin Ther. 2012 May;34(5):1132-44. doi: 10.1016/j.clinthera.2012.03.004. Epub 2012 Apr 27.

title: Cost-Effectiveness Analysis of Interferon Beta-1b for the Treatment of Patients With a First Clinical Event Suggestive of Multiple Sclerosis

ReferenceCitation: Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol. 2009 May 20;9:19. doi: 10.1186/1471-2377-9-19.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Barkhof F, Polman CH, Radue EW, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalbán X, Poppe P, de Vos M, Lasri F, Bauer L, Dahms S, Wagner K, Pohl C, Sandbrink R. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007 Sep;64(9):1292-8.

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Radü EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R; BENEFIT Study Group. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389-97.

ReferenceCitation: De Jager PL, Chibnik LB, Cui J, Reischl J, Lehr S, Simon KC, Aubin C, Bauer D, Heubach JF, Sandbrink R, Tyblova M, Lelkova P; Steering committee of the BENEFIT study; Steering committee of the BEYOND study; Steering committee of the LTF study; Steering committee of the CCR1 study, Havrdova E, Pohl C, Horakova D, Ascherio A, Hafler DA, Karlson EW. Integration of genetic risk factors into a clinical algorithm for multiple sclerosis susceptibility: a weighted genetic risk score. Lancet Neurol. 2009 Dec;8(12):1111-9. doi: 10.1016/S1474-4422(09)70275-3. Epub 2009 Oct 29.

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Germany
United Kingdom
Finland
France
Poland
Israel
Slovenia
Norway
Hungary
Belgium
Portugal
Denmark
Canada
Czech Republic


type: EudraCT Number

title: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

summary: A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

family: Eriksson

full_name: Bengt I. Eriksson

given: Bengt I.

family: Dahl

full_name: Ola E. Dahl

given: Ola E.

family: Rosencher

full_name: Nadia Rosencher

given: Nadia

family: Clemens

full_name: Andreas Clemens

given: Andreas

family: Hantel

full_name: Stefan Hantel

given: Stefan

family: Kurth

full_name: Andreas A. Kurth

given: Andreas A.

title: Efficacy of delayed thromboprophylaxis with dabigatran: Pooled analysis

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

family: Noack

full_name: Herbert Noack

given: Herbert

family: Feuring

full_name: Martin Feuring

given: Martin

family: Friedman

full_name: Richard J Friedman

given: Richard J

full_name: Bengt I Eriksson

given: Bengt I

currency_apc_doaj: GBP

journal_name: Thrombosis Journal

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
Finland
France
Poland
Hungary
Australia
Belgium
Spain
Denmark
Germany
Czech Republic

location_facility: 1160.25.06107 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03605 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03903 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02701 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06101 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03302 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03602 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03105 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03306 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03104 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04573 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04803 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03905 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04575 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42006 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35802 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03304 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03408 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03101 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06106 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06108 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04804 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04605 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06105 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03106 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03403 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03307 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04609 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03604 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03401 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35801 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04603 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35803 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.25.42009 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04574 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03407 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03102 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04610 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04608 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04607 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04301 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04570 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06110 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03601 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06103 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04601 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04806 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03409 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06111 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03906 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02702 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04604 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35804 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03402 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06113 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06104 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06102 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03309 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03305 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06109 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03607 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03301 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02703 Boehringer Ingelheim Investigational Site


title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.

acronym: FLEX

summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

family: Pirker

full_name: Robert Pirker

given: Robert

family: Pereira

full_name: Jose R Pereira

given: Jose R

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Vynnychenko

full_name: Ihor Vynnychenko

given: Ihor

family: Park

full_name: Keunchil Park

given: Keunchil

family: Yu

full_name: Chih-Teng Yu

given: Chih-Teng

family: Ganul

full_name: Valentyn Ganul

given: Valentyn

family: Roh

full_name: Jae-Kyung Roh

given: Jae-Kyung

family: Bajetta

full_name: Emilio Bajetta

given: Emilio

family: O'Byrne

full_name: Kenneth O'Byrne

given: Kenneth

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

family: Eberhardt

full_name: Wilfried Eberhardt

given: Wilfried

family: Goddemeier

full_name: Thomas Goddemeier

given: Thomas

family: Emig

full_name: Michael Emig

given: Michael

family: Gatzemeier

full_name: Ulrich Gatzemeier

given: Ulrich

journal_name: The Lancet

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.

full_name: R. Pirker

given: R.

full_name: J.R. Pereira

full_name: A. Szczesna

given: A.

title: Prognostic factors in patients with advanced non-small cell lung cancer: Data from the phase III FLEX study

ReferenceCitation: Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Störkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.

ReferenceCitation: O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.

ReferenceCitation: Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.

location_country:
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
France
Poland
Slovakia
Argentina
Korea, Republic of
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Ireland
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Turkey


title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

summary: The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

lead_sponsor: Pfizer

location_country:
Italy
Austria
Germany
France
Lithuania
Spain
Canada
United Kingdom


title: A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

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

ReferenceCitation: Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada


title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

acronym: BENEFIT-EXT

summary: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

ReferenceCitation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

family: Dobbels

full_name: Fabienne Dobbels

given: Fabienne

family: Wong

full_name: Schiffon Wong

given: Schiffon

family: Min

full_name: You Min

given: You

family: Sam

full_name: Joo Sam

given: Joo

family: Kalsekar

full_name: Anupama Kalsekar

given: Anupama

journal_name: Transplantation

oa_host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Beneficial Effect of Belatacept on Health-Related Quality of Life and Perceived Side Effects

ReferenceCitation: Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

family: Medina Pestana

full_name: J. O. Medina Pestana

given: J. O.

family: Grinyo

full_name: J. M. Grinyo

given: J. M.

family: Vanrenterghem

full_name: Y. Vanrenterghem

given: Y.

family: Becker

full_name: T. Becker

given: T.

family: Campistol

full_name: J. M. Campistol

family: Florman

full_name: S. Florman

given: S.

family: Garcia

full_name: V. D. Garcia

given: V. D.

family: Kamar

full_name: N. Kamar

given: N.

family: Lang

full_name: P. Lang

given: P.

family: Manfro

full_name: R. C. Manfro

given: R. C.

family: Massari

full_name: P. Massari

family: Rial

full_name: M. D. C. Rial

given: M. D. C.

family: Schnitzler

full_name: M. A. Schnitzler

given: M. A.

family: Vitko

full_name: S. Vitko

title: Three-Year Outcomes From BENEFIT-EXT: A Phase III Study of Belatacept Versus Cyclosporine in Recipients of Extended Criteria Donor Kidneys

location_country:
Italy
Austria
Brazil
Chile
South Africa
Sweden
Germany
France
Czechia
Poland
Norway
Hungary
Argentina
Australia
Belgium
Spain
United States
United Kingdom
Canada

location_facility: Western New England Renal & Transplant Associates, Pc

location_facility: Drexel University College Of Medicine, Department Of Surgery

location_facility: Columbia University College Of Physicians & Surgeons

location_facility: University Of California San Francisco Medical Center

location_facility: University Of Colorado Health Sciences Center

location_facility: University Of North Carolina At Chapel Hill

location_facility: Ucla Kidney & Kidney-Pancreas Transplant Research Office

location_facility: Northwestern University-Feinberg School Of Medicine

location_facility: Washington University School Of Medicine

location_facility: Henry Ford Hospital, Transplant Institute


title: A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis

summary: This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

lead_sponsor: GlaxoSmithKline

location_country:
Peru
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
Ukraine
India
Costa Rica
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Philippines
Bulgaria
Hungary
Ireland
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Mexico
New Zealand
Spain
Latvia


title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, When Administered as 30, 50, and 75 mg Once Daily for 12 Weeks in Subjects With

summary: SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

ReferenceCitation: McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH; TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227-36.

location_country:
United States
France
Puerto Rico
Germany
United Kingdom

intervention_type: Other


title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

summary:
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.

name: Department of Psychiatry and Behavioral Sciences; Stanford University School of Medicine; Stanford California

name: Bipolar and Depression Research Program; VA Palo Alto Health Care System; Palo Alto California

family: Suppes

full_name: Trisha Suppes

given: Trisha

name: Clinical Institute of Neuroscience; Hospital Clinic, IDIBAPS, CIBERSAM, University of Barcelona; Barcelona Spain

family: Vieta

full_name: Eduard Vieta

given: Eduard

family: Gustafsson

full_name: Urban Gustafsson

given: Urban

name: Department of Psychiatry; University of Umeå; Umeå Sweden

family: Ekholm

full_name: Birgit Ekholm

given: Birgit

bso_classification: Social sciences

journal_name: Depression and Anxiety

title: MAINTENANCE TREATMENT WITH QUETIAPINE WHEN COMBINED WITH EITHER LITHIUM OR DIVALPROEX IN BIPOLAR I DISORDER: ANALYSIS OF TWO LARGE RANDOMIZED, PLACEBO-CONTROLLED TRIALS

location_country:
Italy
South Africa
Sweden
United Kingdom
Germany
Finland
France
Bulgaria
Poland
Norway
Hungary
Belgium
Australia
Russian Federation
Spain
Turkey
United States
Czech Republic


title: A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

summary: The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

ReferenceCitation: Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, Vazquez JA, Dupont BF, Horn DL, Ostrosky-Zeichner L, Reboli AC, Suh B, Digumarti R, Wu C, Kovanda LL, Arnold LJ, Buell DN. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007 Oct 1;45(7):883-93. Epub 2007 Aug 29. Erratum in: Clin Infect Dis. 2008 Jul 15;47(2):302.

ReferenceCitation: Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. doi: 10.1093/jac/dkq446. Epub 2010 Dec 8.

family: Shorr

full_name: A. F. Shorr

given: A. F.

family: Wu

full_name: C. Wu

given: C.

family: Kothari

full_name: S. Kothari

bso_classification: Biology (fond.)

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Astellas Pharma Inc

location_country:
Austria
United States
Brazil
India
Switzerland
Netherlands
United Kingdom
Germany
Croatia
France
Poland
Belgium
Spain
Canada
Czech Republic


title: A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

summary: The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

family: Dimopoulos

full_name: M. A. Dimopoulos

family: Orlowski

full_name: R. Z. Orlowski

given: R. Z.

family: Facon

full_name: T. Facon

family: Sonneveld

full_name: P. Sonneveld

family: Anderson

full_name: K. C. Anderson

given: K. C.

family: Beksac

full_name: M. Beksac

given: M.

family: Benboubker

full_name: L. Benboubker

given: L.

family: Roddie

full_name: H. Roddie

given: H.

family: Potamianou

full_name: A. Potamianou

given: A.

family: Couturier

full_name: C. Couturier

family: Feng

full_name: H. Feng

family: Ataman

full_name: O. Ataman

given: O.

family: van de Velde

full_name: H. van de Velde

family: Richardson

full_name: P. G. Richardson

given: P. G.

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Sonneveld P, Hajek R, Nagler A, Spencer A, Bladé J, Robak T, Zhuang SH, Harousseau JL, Orlowski RZ; DOXIL-MMY-3001 Study Investigators. Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. Cancer. 2008 Apr 1;112(7):1529-37. doi: 10.1002/cncr.23326.

full_name: Pieter Sonneveld

given: Pieter

family: Hajek

full_name: Roman Hajek

name: for the DOXIL-MMY-3001 Study Investigators

ReferenceCitation: Orlowski RZ, Nagler A, Sonneveld P, Bladé J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. Epub 2007 Aug 6.

location_country:
Austria
South Africa
United Kingdom
Netherlands
Spain
France
Poland
Israel
Singapore
Argentina
Australia
Belgium
Portugal
Russian Federation
United States
Czech Republic
Canada


title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

ReferenceCitation: Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

family: Hollander

full_name: Priscilla Hollander

given: Priscilla

family: Cooper

full_name: John Cooper

given: John

family: Bregnhøj

full_name: Jesper Bregnhøj

given: Jesper

family: Pedersen

full_name: Claus Bang Pedersen

given: Claus Bang

journal_name: Clinical Therapeutics

lead_sponsor: Novo Nordisk A/S

location_country:
Sweden
Finland
France
Norway
United States


title: A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

summary: This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

ReferenceCitation: Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martín A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Craxi

full_name: Antonio Craxi

given: Antonio

family: Brandao-Mello

full_name: Carlos E. Brandao-Mello

given: Carlos E.

family: Di Bisceglie

full_name: Adrian M. Di Bisceglie

given: Adrian M.

family: Andreone

full_name: Pietro Andreone

given: Pietro

family: Freilich

full_name: Bradley Freilich

given: Bradley

family: Rajender Reddy

full_name: K. Rajender Reddy

given: K.

family: Olveira Martín

full_name: Antonio Olveira Martín

family: Teuber

full_name: Gerlinde Teuber

given: Gerlinde

family: Messinger

full_name: Diethelm Messinger

given: Diethelm

family: Hooper

full_name: Greg Hooper

given: Greg

family: Wat

full_name: Cynthia Wat

given: Cynthia

family: Tatsch

full_name: Fernando Tatsch

given: Fernando

family: Jensen

full_name: Donald M. Jensen

given: Donald M.

journal_name: Journal of Clinical Gastroenterology

title: Predicting Early and Sustained Virological Responses in Prior Nonresponders to Pegylated Interferon alpha-2b Plus Ribavirin Retreated With Peginterferon alpha-2a Plus Ribavirin and the Benefit-Risk Ratio of Retreatment

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Sweden
Switzerland
Spain
Germany
France
Greece
Belgium
Portugal
Turkey
Canada
United Kingdom


title: See Detailed Description

summary: This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

ReferenceCitation: Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. Erratum in: Lancet. 2006 Oct 7;368(9543):1238.

location_country:
Italy
Austria
United States
Luxembourg
Switzerland
Spain
Germany
France
Poland
Romania
Belgium
Portugal
Canada
Latvia


title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

summary: The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

ReferenceCitation: Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

family: Opal

full_name: Steven M Opal

given: Steven M

family: Abraham

full_name: Edward Abraham

given: Edward

family: LaRosa

full_name: Steven P LaRosa

given: Steven P

family: Creasey

full_name: Abla A Creasey

given: Abla A

family: Xie

full_name: Fang Xie

given: Fang

family: Poole

full_name: Lona Poole

given: Lona

family: Wunderink

full_name: Richard G Wunderink

given: Richard G

journal_name: Critical Care

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Chile
Peru
South Africa
Netherlands
Spain
Germany
France
Korea, Republic of
Malaysia
Singapore
Belgium
Argentina
Australia
New Zealand
United States
United Kingdom
Canada


title: A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Solá R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34.

location_country:
Italy
United States
Germany
France
Australia
Puerto Rico
New Zealand
Spain
Canada


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

summary: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

study_start_date_type: Actual

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15. Erratum in: Oncologist. 2010;15(3):327. Schwarzberg, Lee S [corrected to Schwartzberg, Lee S].

ReferenceCitation: Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.

ReferenceCitation: Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.

ReferenceCitation: Prat A, Cheang MCU, Galván P, et al (2016). Prognostic and predictive abilities of intrinsic subtype in hormone receptor-positive metastatic breast cancer from the EGF30008 phase III clinical trial. JAMA Oncol. 2(10):1287-94.

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

name: All authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

family: Wedam

full_name: Suparna B. Wedam

given: Suparna B.

family: Beaver

full_name: Julia A. Beaver

given: Julia A.

family: Amiri-Kordestani

full_name: Laleh Amiri-Kordestani

given: Laleh

family: Bloomquist

full_name: Erik Bloomquist

given: Erik

family: Tang

full_name: Shenghui Tang

given: Shenghui

family: Goldberg

full_name: Kirsten B. Goldberg

given: Kirsten B.

family: Sridhara

full_name: Rajeshwari Sridhara

given: Rajeshwari

family: Ibrahim

full_name: Amna Ibrahim

given: Amna

family: Kim

full_name: Geoffrey Kim

given: Geoffrey

family: Kluetz

full_name: Paul Kluetz

given: Paul

family: McKee

full_name: Amy McKee

given: Amy

family: Pazdur

full_name: Richard Pazdur

given: Richard

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing: Yes

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

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

location_country:
Peru
Australia
Russian Federation
Denmark
Pakistan
Croatia
France
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Netherlands
Bulgaria
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Tunisia
New Zealand
Spain
Turkey


title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

summary:
The purposes of this study are to determine:

Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

ReferenceCitation: Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.

family: Farris

full_name: Reid W. D. Farris

given: Reid W. D.

family: Weiss

full_name: Noel S. Weiss

given: Noel S.

family: Zimmerman

full_name: Jerry J. Zimmerman

given: Jerry J.

journal_name: Pediatric Critical Care Medicine

title: Functional Outcomes in Pediatric Severe Sepsis

ReferenceCitation: Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.

family: Nadel

full_name: Simon Nadel

given: Simon

family: Goldstein

full_name: Brahm Goldstein

given: Brahm

family: Williams

full_name: Mark D Williams

given: Mark D

family: Dalton

full_name: Heidi Dalton

given: Heidi

family: Peters

full_name: Mark Peters

given: Mark

family: Macias

full_name: William L Macias

given: William L

family: Abd-Allah

full_name: Shamel A Abd-Allah

given: Shamel A

family: Levy

full_name: Howard Levy

given: Howard

family: Angle

full_name: Robinette Angle

given: Robinette

family: Wang

full_name: Dazhe Wang

given: Dazhe

family: Sundin

full_name: David P Sundin

given: David P

family: Giroir

full_name: Brett Giroir

given: Brett

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Chile
Switzerland
Mexico
France
Poland
Slovakia
Australia
Germany
United Kingdom

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


title: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

summary:
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.

The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

lead_sponsor: Forest Laboratories

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

location_facility: Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170

location_facility: Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29

location_facility: Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2

location_facility: Clinica Puerta de Hierro, San Martin de Porres, 4

location_facility: St Michaels Hospital 30 Bond Street 7-050 Queen

location_facility: Hopital cardiologique du Haut Leveque-av. de Magellan

location_facility: Medizinische Universitatsklinik Leipzigerstr. 44

location_facility: Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25

location_facility: Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11

location_facility: Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600

location_facility: Hamilton General Hospital/McMaster Clinic

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1

location_facility: Deutsches Herzzentrum Minchen Lazarettstr. 36

location_facility: CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod

location_facility: Cardiac Arrythmia Trials/Royal Jubilee Hosp.

location_facility: Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2

location_facility: Klinikum Grobhadern Universitat Munchen Marchioninistr. 15

location_facility: Baystate Medical Center-Cardiology Research

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7

location_facility: Klinikum der Stadt Ludwigshafen Bremserstr. 79

location_facility: Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9

location_facility: SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1

location_facility: UT Southwestern Medical Center at Dallas

location_facility: CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc

location_facility: Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20

location_facility: ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1

location_facility: Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1

location_facility: Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50

location_facility: CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu

location_facility: Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4

location_facility: Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52

location_facility: Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40

location_facility: Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20

location_facility: Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50

location_facility: Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42

location_facility: Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

location_facility: University of Rochester Strong mem. Hospital

location_facility: Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11

location_facility: Louisville Cardiology Medical Group, PSC

location_facility: Mid-America Cardiology c/o KU medical Ctr

location_facility: 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47

location_facility: CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours

location_facility: Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58

location_facility: Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8

location_facility: University of Mass. Medical Ctr. Division of Cardiovascular Medicine

location_facility: CHRU de Nancy-29 av. de Lattre de Tassigny

location_facility: Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20

location_facility: Memorial Health Systems/Cardiology Research Associates

location_facility: Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25

location_facility: Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5

location_facility: Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40

location_facility: Centre hospitalier L. Pradel-28 av. du doyen Lepine

location_facility: The Cardiovascular Grp./Attn: Mandy Murphy

location_facility: Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3

location_facility: Oddzial kardiologii-Instut kardiologii, Ul Powstancow

location_facility: Catharina Ziekenhuis Afd. Cardiologie Postbus 1350

location_facility: Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10

location_facility: Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n

location_facility: Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18

location_facility: Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1

location_facility: Heart Place/Baylor University of Medicine


title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

summary: DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Italy
Austria
Brazil
India
Hong Kong
Netherlands
Spain
Germany
France
Japan
Poland
Belgium
China
Turkey
Denmark
United States
Korea, Republic of
Taiwan

status_simplified: Ongoing


status: Active, not recruiting

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Austria
United States
Brazil
Mexico
France
Czechia
Argentina
Puerto Rico
China
Denmark
Canada
Taiwan

acronym: ONWARDS 3

source: euctr

title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

summary:
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.

Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
France
Japan
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Sarah Cannon (Tennessee Oncology - Nashville)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: Severance Hospital Yonsei University Health System

location_facility: Aienda Ospedaliera San Camillo Forlanini

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Clinica Universitaria de Navarra - Madrid

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centre de Lutte Contre le Cancer CLCC - Institut Curie

title: A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Finland
Greece
Australia
Russian Federation
Croatia
France
Poland
Norway
Canada
Slovenia
Korea, Republic of
Colombia
Hungary
Portugal
China
United States
Germany
United Kingdom
Italy
Brazil
Spain
Turkey

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi

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

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Oslo Universitetssykehus HF; Ullevål sykehus

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Sykehuset Østfold Kalnes; Onkologisk seksjon

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: FSBSI "N. N. Blokhin Russian Cancer Research Center"

location_facility: CHUS (Centre Hospitalier Universitaire de Sherbrooke)

location_facility: Zhejiang Provincial People's Hospital; Oncology& Breast

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Hospital Universitario Quiron Madrid; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team

location_facility: Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center

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

location_facility: Acibadem University School of Medicine Altunizade Hospital Oncology Service

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare LOXO-305 to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

ipd_sharing: No

lead_sponsor: Loxo Oncology, Inc.

location_country:
Italy
Austria
Netherlands
Spain
France
Czechia
Japan
Poland
Australia
Belgium
New Zealand
Portugal
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Wake Forest University School of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: The Oncology Institute of Hope and Innovation

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Cancer Center Office of Clinical Research

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Medical Oncology Hematology Consultants, PA


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


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms

summary:
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.

However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.

The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.

Also data on the safety of the product in the disease will be collected.

ReferenceCitation: Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.

family: Barone

full_name: Paolo Barone

given: Paolo

family: Poewe

full_name: Werner Poewe

given: Werner

family: Albrecht

full_name: Stefan Albrecht

given: Stefan

family: Debieuvre

full_name: Catherine Debieuvre

given: Catherine

family: Massey

full_name: Dan Massey

given: Dan

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Tolosa

full_name: Eduardo Tolosa

given: Eduardo

family: Weintraub

full_name: Daniel Weintraub

given: Daniel

journal_name: The Lancet Neurology

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
Finland
France
Norway
Romania
Russian Federation
Spain
Germany
Ukraine

location_facility: 248.596.47003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología

location_facility: 248.596.47002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"

location_facility: 248.596.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.596.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39003 Università degli studi di Napoli "Federico II"

location_facility: 248.596.40001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología

location_facility: 248.596.39007 Clinica Neurologica Policlinico Tor Vergata

location_facility: 248.596.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.47004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34004 Hospital General de Catalunya. Departamento de Neurología

location_facility: 248.596.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología

location_facility: 248.596.49013 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34003 Hospital de Alcorcón. Departamento de Neurología

location_facility: 248.596.39009 Istituti Clinici di Perfezionamento

location_facility: 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA

location_facility: 248.596.40006 Country Clinical Emergency Hospital

location_facility: 248.596.27003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3301A Hôpital Guillaume et René Laennec

location_facility: 248.596.39006 Neurologia Ospedale Evangelico Valdese

location_facility: 248.596.38002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3302A Centre Hospitalier du Pays d'Aix

location_facility: 248.596.70001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39004 Neurologia Ospedale della Misericordia

location_facility: 248.596.46004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39005 Clinica Neurologica Policlinico G. Martino

location_facility: 248.596.3302B Centre Hospitalier du Pays d'Aix

location_facility: 248.596.27007 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.596.31004 Amphia ziekenhuis, Locatie Molengracht

location_facility: 248.596.70004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología

location_facility: 248.596.38005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39008 Clinica Neurologica I Policlinico di Catania


title: Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

summary: The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

lead_sponsor: Bayer

location_country: Austria Finland France Spain


title: A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

acronym: CHOICE

summary: This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

ReferenceCitation: Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.

family: Sturdee

full_name: D. W. Sturdee

given: D. W.

family: Archer

full_name: D. F. Archer

given: D. F.

family: Rakov

full_name: V. Rakov

given: V.

family: Lang

full_name: E. Lang

given: E.

family: on behalf of the CHOICE Study Inves

full_name: on behalf of the CHOICE Study Inves

journal_name: Climacteric

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56.

ReferenceCitation: Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31.

location_country:
Austria
Sweden
Switzerland
Finland
France
Norway
Belgium
Denmark
Germany
United Kingdom


title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

summary: This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

ReferenceCitation: Vilsbøll T, Brock B, Perrild H, Levin K, Lervang HH, Kølendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.

family: Vilsbøll

full_name: T. Vilsbøll

given: T.

family: Brock

full_name: B. Brock

given: B.

family: Perrild

full_name: H. Perrild

given: H.

family: Levin

full_name: K. Levin

given: K.

family: Lervang

full_name: H.-H. Lervang

family: Kølendorf

full_name: K. Kølendorf

family: Krarup

full_name: T. Krarup

family: Schmitz

full_name: O. Schmitz

given: O.

family: Zdravkovic

full_name: M. Zdravkovic

given: M.

family: Le-Thi

full_name: T. Le-Thi

family: Madsbad

full_name: S. Madsbad

given: S.

journal_name: Diabetic Medicine

ReferenceCitation: Courrèges JP, Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Bugáñová I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x.

family: Courrèges

full_name: J.-P. Courrèges

family: Verhoeven

full_name: R. Verhoeven

given: R.

family: Bugáñová

full_name: I. Bugáñová

given: I.

ReferenceCitation: Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courrèges JP, Verhoeven R, Bugánová I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. Epub 2007 Mar 19.

ReferenceCitation: Horowitz M, Vilsbøll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

title: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials


title: A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

summary: The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

location_country:
Italy
South Africa
Netherlands
Germany
France
Belgium
Denmark
Canada

location_facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus

location_facility: Med. Einrichtung der Universitat zu Koln

location_facility: Department of Medicine, Health Sciences Centre

location_facility: Boehringer Ingelheim Investigational Site

location_facility: A. O. Universitaria di Ferrara - Arcispedale S. Anna

location_facility: A.O. S. Martino e Cliniche Universitarie di Genova