title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

design_allocation: Non-Randomized

ReferenceCitation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

name: Yale University School of Medicine  New Haven Connecticut USA

family: Inzucchi

full_name: Silvio E. Inzucchi

given: Silvio E.

name: Diabetes Research Centre, University of Leicester  Leicester UK

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

family: Khunti

full_name: Kamlesh Khunti

given: Kamlesh

name: Boehringer Ingelheim International GmbH  Ingelheim Germany

family: Trivedi

full_name: Prabhav Trivedi

given: Prabhav

family: George

full_name: Jyothis T. George

given: Jyothis T.

name: Boehringer Ingelheim Pharma GmbH & Co. KG  Ingelheim Germany

family: Zwiener

full_name: Isabella Zwiener

given: Isabella

name: Boehringer Ingelheim Norway KS  Asker Norway

family: Johansen

full_name: Odd Erik Johansen

given: Odd Erik

name: Institute of Cardiovascular & Medical Sciences, University of Glasgow  Glasgow UK

family: Sattar

full_name: Naveed Sattar

given: Naveed

journal_name: Diabetes, Obesity and Metabolism

title: Empagliflozin treatment effects across categories of baseline HbA1c , body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes

ReferenceCitation: Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.

family: Shiba

full_name: Teruo Shiba

given: Teruo

family: Ishii

full_name: So Ishii

given: So

family: Okamura

full_name: Tomoo Okamura

given: Tomoo

family: Mitsuyoshi

full_name: Rika Mitsuyoshi

given: Rika

family: Pfarr

full_name: Egon Pfarr

given: Egon

family: Koiwai

full_name: Kazuki Koiwai

given: Kazuki

journal_name: Diabetes Research and Clinical Practice

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND™ MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.

name: On behalf of the EMPA-REG EXTEND™ MONO investigators

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

ReferenceCitation: Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND™ METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.

location_country:
United States
India
Switzerland
Mexico
Philippines
Germany
France
Japan
Greece
Slovakia
Ireland
Belgium
China
Turkey
Canada
Slovenia
Korea, Republic of
Taiwan
Ukraine

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type: Other Identifier

title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

acronym: Serve-HF

summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Cowie MR, Wegscheider K, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Heart Failure. N Engl J Med. 2016 Feb 18;374(7):690-1. doi: 10.1056/NEJMc1515007.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

version: submittedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Eulenburg C, Wegscheider K, Woehrle H, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Cowie MR. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modelling analysis. Lancet Respir Med. 2016 Nov;4(11):873-881. doi: 10.1016/S2213-2600(16)30244-2. Epub 2016 Aug 31.

family: Eulenburg

full_name: Christine Eulenburg

given: Christine

sequence: first

family: Wegscheider

full_name: Karl Wegscheider

given: Karl

sequence: additional

family: Woehrle

full_name: Holger Woehrle

given: Holger

family: Angermann

full_name: Christiane Angermann

given: Christiane

family: d'Ortho

full_name: Marie-Pia d'Ortho

given: Marie-Pia

family: Erdmann

full_name: Erland Erdmann

given: Erland

family: Levy

full_name: Patrick Levy

given: Patrick

family: Simonds

full_name: Anita K Simonds

given: Anita K

family: Somers

full_name: Virend K Somers

given: Virend K

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Teschler

full_name: Helmut Teschler

given: Helmut

family: Cowie

full_name: Martin R Cowie

given: Martin R

journal_name: The Lancet Respiratory Medicine

repository_institution: Imperial College London - Spiral

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Wegscheider K. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017 Aug 31;50(2). pii: 1601692. doi: 10.1183/13993003.01692-2016. Print 2017 Aug.

full_name: Martin R. Cowie

given: Martin R.

ReferenceCitation: Shafazand S, Badr MS. Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure. J Clin Sleep Med. 2016 Jan;12(1):147-50. doi: 10.5664/jcsm.5420.

name: Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, University of Miami, Miller School of Medicine

name: Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Wayne State University, School of Medicine

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

location_country:
Sweden
Switzerland
Netherlands
Finland
France
Czechia
Norway
Australia
Denmark
Germany
United Kingdom

location_facility: Hospices Civils de Lyon, Hopital de la Croix-Rousse

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Centre Hospitalier d'Antibes Juan-les-Pins

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl

location_facility: Kardiologische Praxis Dr. Siegfried Frickel

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

location_facility: Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

location_facility: Westdeutsches Herzzentrum, Universitätsklinikum Essen

location_facility: Gemeinschaftspraxis Dres. Brandt / Jakobs

location_facility: Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

location_facility: Kardiologische Praxis Dr. Burkhard-Meier

location_facility: Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

location_facility: Gemeinschaftspraxis Dres. Wauer / Windstetter

location_facility: Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz

location_facility: CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

location_facility: Charité Campus Mitte CCM- Schlafmedizinisches Zentrum


title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

summary: This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

family: Kessler

full_name: R. Kessler

given: R.

family: Partridge

full_name: M. R. Partridge

given: M. R.

family: Miravitlles

full_name: M. Miravitlles

given: M.

family: Cazzola

full_name: M. Cazzola

family: Vogelmeier

full_name: C. Vogelmeier

given: C.

family: Leynaud

full_name: D. Leynaud

given: D.

family: Ostinelli

full_name: J. Ostinelli

given: J.

journal_name: European Respiratory Journal

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Finland
France
Greece
Norway
Ireland
Belgium
Portugal
Turkey
Denmark
Germany
United Kingdom

lead_sponsor_type: industriel

status_simplified: Completed


title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

summary: This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gómez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

family: Jones

full_name: Graeme Jones

given: Graeme

family: Wallace

full_name: Thomas Wallace

given: Thomas

family: McIntosh

full_name: Matthew J. McIntosh

given: Matthew J.

family: Brockwell

full_name: Laura Brockwell

given: Laura

family: Gómez-Reino

full_name: Juan J. Gómez-Reino

given: Juan J.

family: Sebba

full_name: Anthony Sebba

given: Anthony

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Iceland
Costa Rica
France
Panama
Lithuania
Thailand
Norway
Argentina
Canada
Slovenia
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Israel
Spain

intervention_type: Drug


ReferenceType: background

ReferenceCitation: Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd. Erratum in: Transplantation. 2014 Mar 27;97(6):38.

ReferenceCitation: Krämer BK, Albano L, Banas B, Charpentier B, Bäckman L, Tedesco-Silva H Jr, Lehner F, Mondragón-Ramírez GA, Glyda M, Cassuto-Viguier E, Viklický O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

family: Krämer

full_name: B.K. Krämer

family: Albano

full_name: L. Albano

given: L.

family: Banas

full_name: B. Banas

given: B.

family: Charpentier

full_name: B. Charpentier

family: Bäckman

full_name: L. Bäckman

family: Tedesco-Silva

full_name: H. Tedesco-Silva

given: H.

suffix: Jr.

family: Lehner

full_name: F. Lehner

given: F.

family: Mondragón-Ramírez

full_name: G.A. Mondragón-Ramírez

family: Glyda

full_name: M. Glyda

family: Cassuto-Viguier

full_name: E. Cassuto-Viguier

given: E.

family: Viklický

full_name: O. Viklický

given: O.

family: Mourad

full_name: G. Mourad

given: G.

family: Rigotti

full_name: P. Rigotti

given: P.

family: Schleibner

full_name: S. Schleibner

given: S.

family: Kamar

full_name: N. Kamar

given: N.

journal_name: Transplantation Proceedings

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

study_start_date_type: Actual

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

lead_sponsor: Astellas Pharma Inc

primary_purpose: Prevention

location_country:
Greece
Romania
Belgium
Russian Federation
France
Poland
Slovakia
Norway
Argentina
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Spain

acronym: OSAKA

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

summary: To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus


title: An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

summary: The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country: Macedonia, The Former Yugoslav Republic of

intervention_type: Other


ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

name: Glenn Heller, Martin Fleisher, and Howard I. Scher, Memorial Sloan Kettering Cancer Center; Howard I. Scher, Weill Cornell Medical College, New York, NY; Robert McCormack, Janssen Research & Development, Raritan, NJ; Thian Kheoh and Arturo Molina, Janssen Research & Development, Los Angeles; Dana T. Aftab, Exelixis, South San Francisco; Mohammad Hirmand, Medivation, San Francisco, CA; Matthew R. Smith, Massachusetts General Hospital, Boston; Ana Limon, Takeda Oncology, Cambridge, MA; Robert Dreicer,...

family: Heller

full_name: Glenn Heller

given: Glenn

family: McCormack

full_name: Robert McCormack

given: Robert

family: Kheoh

full_name: Thian Kheoh

given: Thian

family: Molina

full_name: Arturo Molina

given: Arturo

family: Smith

full_name: Matthew R. Smith

given: Matthew R.

family: Dreicer

full_name: Robert Dreicer

family: Saad

full_name: Fred Saad

given: Fred

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Aftab

full_name: Dana T. Aftab

given: Dana T.

family: Hirmand

full_name: Mohammad Hirmand

given: Mohammad

family: Limon

full_name: Ana Limon

given: Ana

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Fleisher

full_name: Martin Fleisher

given: Martin

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Scher

full_name: Howard I. Scher

given: Howard I.

journal_name: Journal of Clinical Oncology

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

name: Clinical PharmacologyMillennium Pharmaceuticals, Inc.Cambridge Massachusetts USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

family: Suri

full_name: A Suri

given: A

name: Ann Arbor Pharmacometrics GroupAnn Arbor Michigan USA

family: Chapel

full_name: S Chapel

given: S

name: Drug Metabolism and PharmacokineticsMillennium Pharmaceuticals, Inc.Cambridge Massachusetts USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

family: Lu

full_name: C Lu

given: C

family: Venkatakrishnan

full_name: K Venkatakrishnan

given: K

journal_name: Clinical Pharmacology & Therapeutics

title: Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis

ReferenceCitation: Saad F, Fizazi K, Jinga V, Efstathiou E, Fong PC, Hart LL, Jones R, McDermott R, Wirth M, Suzuki K, MacLean DB, Wang L, Akaza H, Nelson J, Scher HI, Dreicer R, Webb IJ, de Wit R; ELM-PC 4 investigators. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 2015 Mar;16(3):338-48. doi: 10.1016/S1470-2045(15)70027-6. Epub 2015 Feb 18.

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
Spain
France
Japan
Lithuania
Poland
Slovakia
Canada
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Belarus
Latvia

title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)


title: A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock

summary: The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

ReferenceCitation: Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-α polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.

family: Yates

full_name: James W. T. Yates

given: James W. T.

family: Das

full_name: Shampa Das

given: Shampa

family: Mainwaring

full_name: Guy Mainwaring

given: Guy

family: Kemp

full_name: John Kemp

given: John

journal_name: Journal of Pharmacokinetics and Pharmacodynamics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_country:
Finland
France
Belgium
Australia
Spain
Canada
Czech Republic


title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

acronym: TRILOGY ACS

summary: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

ReferenceCitation: Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.

name: Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).

family: Marquis-Gravel

full_name: Guillaume Marquis-Gravel

given: Guillaume

family: Neely

full_name: Megan L. Neely

given: Megan L.

name: Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).

family: Valgimigli

full_name: Marco Valgimigli

given: Marco

name: Department of Clinical and Experimental Medicine, Policlinic “G. Martino”, University of Messina, Italy (F.C.).

family: Costa

full_name: Francesco Costa

given: Francesco

name: Department of Biomedical Data Sciences, Leiden University Medical Center, the Netherlands (D.V.K.).

name: Predictive Analytics and Comparative Effectiveness Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA (D.V.K.).

family: Van Klaveren

full_name: David Van Klaveren

given: David

family: Altner

full_name: Rituparna Altner

given: Rituparna

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

name: Canadian VIGOUR Centre and Division of Cardiology, University of Alberta, Edmonton, Canada (P.W.A.).

family: Armstrong

full_name: Paul W. Armstrong

given: Paul W.

name: Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).

family: Fox

full_name: Keith A. A. Fox

given: Keith A. A.

name: Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand (H.D.W.).

family: White

full_name: Harvey D. White

given: Harvey D.

name: Division of Cardiology, Duke University School of Medicine, Durham, NC (E.M.O., M.T.R.).

family: Ohman

full_name: E. Magnus Ohman

given: E. Magnus

family: Roe

full_name: Matthew T. Roe

given: Matthew T.

journal_name: Circulation: Cardiovascular Quality and Outcomes

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.

family: Kaul

full_name: Padma Kaul

given: Padma

family: Alexander

full_name: Karen P. Alexander

given: Karen P.

family: Savu

full_name: Anamaria Savu

given: Anamaria

family: Goodman

full_name: Shaun G. Goodman

given: Shaun G.

full_name: Keith A. Fox

given: Keith A.

title: Sex And Prognostic Significance of Self-Reported Frailty in Non–ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial

ReferenceCitation: Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.

name: Division of Cardiology (A.C.F., R.D.L., E.M.O., M.T.R.), Duke University, Durham, NC.

name: Duke Clinical Research Institute (A.C.F., D.C., M.L.N., R.D.L., E.M.O., M.T.R.), Duke University, Durham, NC.

name: Division of Cardiology, University of Alberta and the Canadian VIGOUR Centre, Edmonton (J.B., P.W.A.).

name: Green Lane Cardiovascular Service, Auckland City Hospital and University of Auckland, New Zealand (H.D.W.).

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.

name: Department of Medicine, National University of Singapore; Singapore

name: Duke Clinical Research Institute, Durham, NC

name: St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada

name: Department of Cardiology, Faculty of Medicine, Lund University, Lund, Sweden

name: Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands

name: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK

name: Canadian VIGOUR Centre and Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

name: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand

name: Centre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India

name: The 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud Private University, Medical School, Vienna, Austria

title: Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non–ST-Segment Elevation Acute Coronary Syndrome

ReferenceCitation: Goldstein SA, Newby LK, Cyr DD, Neely M, Lüscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4). pii: e005334. doi: 10.1161/JAHA.116.005334.

name: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC

name: University Hospital Zurich, Zurich, Switzerland

journal_name: Journal of the American Heart Association

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Relationship Between Peak Troponin Values and Long‐Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes

ReferenceCitation: Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11). pii: e003977.

ReferenceCitation: Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalán R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.

ReferenceCitation: Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.

journal_name: Journal of the American College of Cardiology

title: Spontaneous MI After Non–ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization

ReferenceCitation: Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.

ReferenceCitation: Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalán R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.

name: From the Cardiology Department, National Heart Centre Singapore, and Duke-NUS Graduate Medical School, Singapore (C.T.C.); Duke Clinical Research Institute, Durham, NC (B.N., E.M.O., M.T.R.); Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC (E.M.O., M.T.R.); Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada (P.W.A.); Department of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago,...

ReferenceCitation: Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.

ReferenceCitation: Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.

title: Long-term outcomes for women versus men with unstable angina/non–ST-segment elevation myocardial infarction managed medically without revascularization: Insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

name: Department of Medicine, Stanford University, Stanford, CA

name: Green Lane Cardiovascular Service, Auckland, New Zealand

name: Division of Cardiology, University of Alberta, Edmonton, Canada

name: Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

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

repository_institution: The Pennsylvania State University - CiteSeer X

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: The Pennsylvania State University - CiteSeer X

title: Meta‐Analysis of Intracranial Hemorrhage in Acute Coronary Syndromes: Incidence, Predictors, and Clinical Outcomes

ReferenceCitation: Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.

ReferenceCitation: Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24. Erratum in: Am Heart J. 2014 Oct;168(4):605.

ReferenceCitation: Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8. Erratum in: Lancet. 2013 Aug 31;382(9894):768.

ReferenceCitation: Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.

title: Platelet Function During Extended Prasugrel and Clopidogrel Therapy for Patients With ACS Treated Without Revascularization

ReferenceCitation: Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteză M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

title: Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization

ReferenceCitation: Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12. Review.

title: Importance of potent P2Y12receptor blockade in acute myocardial infarction: focus on prasugrel

ReferenceCitation: Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.

title: Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non–ST-segment elevation myocardial infarction: The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
Costa Rica
Spain
Croatia
France
Lithuania
Panama
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Philippines
Bulgaria
Malta
Hungary
Ireland
Puerto Rico
Singapore
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Tunisia
Egypt
New Zealand
Turkey

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

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

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

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


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

name: Atsushi Ohtsu, National Cancer Center Hospital East, Kashiwa; Keisho Chin, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo; Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan; Jaffer A. Ajani, University of Texas MD Anderson Cancer Center, Houston, TX; Tarek Sahmoud, Heind Smith, Syed Rizvi, David Lebwohl, Novartis Pharmaceuticals, Florham Park, NJ; Yu-Xian Bai, Tumor Hospital of Harbin Medical University, Harbin; Hong-Ming Pan, Sir Run Run Shaw Hospital, Zhejiang; Lin Shen...

family: Ohtsu

full_name: Atsushi Ohtsu

given: Atsushi

family: Ajani

full_name: Jaffer A. Ajani

given: Jaffer A.

family: Bai

full_name: Yu-Xian Bai

given: Yu-Xian

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

family: Chung

full_name: Hyun-Cheol Chung

given: Hyun-Cheol

family: Pan

full_name: Hong-Ming Pan

given: Hong-Ming

family: Sahmoud

full_name: Tarek Sahmoud

given: Tarek

family: Shen

full_name: Lin Shen

given: Lin

family: Yeh

full_name: Kun-Huei Yeh

given: Kun-Huei

family: Chin

full_name: Keisho Chin

given: Keisho

family: Muro

full_name: Kei Muro

given: Kei

family: Kim

full_name: Yeul Hong Kim

given: Yeul Hong

family: Ferry

full_name: David Ferry

family: Tebbutt

full_name: Niall C. Tebbutt

given: Niall C.

family: Al-Batran

full_name: Salah-Eddin Al-Batran

given: Salah-Eddin

family: Smith

full_name: Heind Smith

given: Heind

family: Costantini

full_name: Chiara Costantini

given: Chiara

family: Rizvi

full_name: Syed Rizvi

given: Syed

family: Lebwohl

full_name: David Lebwohl

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study

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

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

location_facility: University of Washington Cancer Care Seattle Cancer Alliance

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: Loma Linda Oncology Medical Group Loma Linda

location_facility: Henry Ford Hospital Dept. of Henry Ford Hospital

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

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

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

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


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

name: Xavier Pivot, Centre Hospitalier Universitaire, Hôpital Jean Minjoz, Besançon, France; Alexey Manikhas, St Petersburg City Oncology Dispensary; Vladimir Semiglazov, Petrov Research Institute of Oncology, St Petersburg, Russian Federation; Bogdan Żurawski, Franciszek Lukaszczyk Oncology Center, Bydgoszcz; Ewa Chmielowska, Centrum Onkologii im. Prof Franciszka Lukaszczyka Oddzial Kliniczny Onkologii, Bydgoszcz, and Uniwersytet Mikolaja Kopernika Torun, Torun; Boguslawa Karaszewska, Przychodnia Lekarska...

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Manikhas

full_name: Alexey Manikhas

given: Alexey

family: Żurawski

full_name: Bogdan Żurawski

given: Bogdan

family: Chmielowska

full_name: Ewa Chmielowska

given: Ewa

family: Karaszewska

full_name: Boguslawa Karaszewska

given: Boguslawa

family: Allerton

full_name: Rozenn Allerton

given: Rozenn

family: Chan

full_name: Stephen Chan

given: Stephen

family: Fabi

full_name: Alessandra Fabi

given: Alessandra

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Gori

full_name: Stefania Gori

given: Stefania

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: Dank

full_name: Magdolna Dank

given: Magdolna

family: Hornyak

full_name: Lajos Hornyak

given: Lajos

family: Margolin

full_name: Sara Margolin

given: Sara

family: Nusch

full_name: Arnd Nusch

given: Arnd

family: Parikh

full_name: Roma Parikh

given: Roma

family: Nagi

full_name: Fareha Nagi

given: Fareha

family: DeSilvio

full_name: Michelle DeSilvio

given: Michelle

family: Santillana

full_name: Sergio Santillana

given: Sergio

family: Swaby

full_name: Ramona F. Swaby

given: Ramona F.

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

publisher_group: American Society of Clinical Oncology (ASCO)

title: CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

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

lead_sponsor: Novartis Pharmaceuticals

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

ipd_sharing: Undecided

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

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


ReferenceCitation: Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.

family: Vandenberghe

full_name: Rik Vandenberghe

given: Rik

name: for the Bapineuzumab 3000 and 3001 Clinical Study Investigators

family: Rinne

full_name: Juha O. Rinne

given: Juha O.

family: Boada

full_name: Mercè Boada

given: Mercè

family: Katayama

full_name: Sadao Katayama

given: Sadao

family: Scheltens

full_name: Philip Scheltens

given: Philip

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Tuchman

full_name: Michael Tuchman

given: Michael

family: Gass

full_name: Achim Gass

given: Achim

family: Fiebach

full_name: Jochen B. Fiebach

given: Jochen B.

family: Hill

full_name: Derek Hill

given: Derek

family: Lobello

full_name: Kasia Lobello

given: Kasia

family: Li

full_name: David Li

given: David

family: McRae

full_name: Tom McRae

given: Tom

family: Lucas

full_name: Prisca Lucas

given: Prisca

family: Evans

full_name: Iona Evans

given: Iona

family: Booth

full_name: Kevin Booth

given: Kevin

family: Luscan

full_name: Gerald Luscan

given: Gerald

family: Wyman

full_name: Bradley T. Wyman

given: Bradley T.

family: Hua

full_name: Lisa Hua

given: Lisa

family: Yang

full_name: Lingfeng Yang

given: Lingfeng

family: Brashear

full_name: H. Robert Brashear

given: H. Robert

family: Black

full_name: Ronald S. Black

given: Ronald S.

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: University College London - UCL Discovery

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery
refubium.fu-berlin.de

repositories_institution: University College London - UCL Discovery

title: Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials

ReferenceCitation: Lacey L, Bobula J, Rüdell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.

title: Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer’s Disease: Determinants and Level of Changes Observed

location_country:
Finland
Australia
Belgium
Croatia
France
Japan
Poland
Slovakia
Argentina
South Africa
Chile
Sweden
Switzerland
Netherlands
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
New Zealand
Spain

location_facility: Psychiatricka nemocnica Michalovce, n.o.

location_facility: National Hospital Organization Maizuru Medical Center

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: University of Pennsylvania-Penn Memory Center

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: University of Michigan Hospital and Health System

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: National Hospital Organization Kokura Medical Center

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Unita' Operativa Complessa di Neurologia

location_facility: Institute for Cardiovascular Diseases of Vojvodina

location_facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

location_facility: Fundacio ACE Institut Catala de Neurociences Aplicades

location_facility: Participant and Clinical Interactions Resources

location_facility: Sezione di Neurologia - Dipartimento di Neuroscienze

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: Alzheimer's Research Corp./Merician Institute for Aging

location_facility: Ohio State University Imaging@Martha Moorehouse

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: UAB Clinical Research Pharmacy-Russell Clinic

location_facility: Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: Centre d'Imagerie medicale de Basse Normandie

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Wm S. Middleton Memorial Veterans Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: General Clincial Research Center (Infusion Location)

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: The Center for Pharmaceutical Research P.C.

location_facility: Kansai Medical University Takii Hospital

location_facility: Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,

location_facility: Rhode Island Mood and Memory Research Institute

location_facility: Kobe City Hospital Org Kobe City Medical Cente West Hp

location_facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

location_facility: Clinical Centre Kragujevac, Clinic of Psichiatry

location_facility: Centro Internacional de Medicina Avanzda (CIMA)

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

location_facility: McCusker Alzheimer's Research Foundation, Inc.

location_facility: UPENN Clinical and Transitional Research Center

location_facility: MAC UK Neuroscience, Research Assessment Centre

location_facility: National Hospital Organization Niigata National Hospital

location_facility: Carolina Neuropsychological Services, Inc

location_facility: CeSI (Centro di Scienze dell'invecchiamento) -

location_facility: Southern Illinois University School of Medicine Department

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong

title: A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers

summary: This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.


family: Vandenberghe

full_name: Rik Vandenberghe

given: Rik

family: Rinne

full_name: Juha O. Rinne

given: Juha O.

family: Boada

full_name: Mercè Boada

given: Mercè

family: Katayama

full_name: Sadao Katayama

given: Sadao

family: Scheltens

full_name: Philip Scheltens

given: Philip

family: Vellas

full_name: Bruno Vellas

given: Bruno

repositories_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

location_country:
Finland
Belgium
Australia
Russian Federation
Croatia
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Switzerland
Netherlands
Portugal
United States
Germany
United Kingdom
Italy
Serbia
Mexico
New Zealand
Spain

location_facility: Psychiatricka nemocnica Michalovce, n.o.

location_facility: Methodist Medical Center Research Department

location_facility: Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych

location_facility: National Hospital Organization Maizuru Medical Center

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: Memory Enhancement Center of New Jersey, Inc.

location_facility: KonKuk University Hospital, Department of NeuroPsychiatry

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: University of Rochester/Strong Memorial Hospital

location_facility: UPENN Clinical and Translational Research Center (CTRC)

location_facility: Hospital of the University of Pennsylvania (PET)

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Fundació ACE Institut Catala de Neurociences Aplicades

location_facility: National Hospital Organization Kokura Medical Center

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: AD-CARE, University of Rochester Medical Center

location_facility: Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Unita' Operativa Complessa di Neurologia

location_facility: Medical Research and Health Education Foundation, Incorporated

location_facility: University of Viriginia Investigational Pharmacy

location_facility: Institute for Neurodegenerative Disorders

location_facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Medical University of South Carolina Investigational Drug Service

location_facility: Alexian Brothers Neurosciences Institute

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Clinical Trials of America, Incorporated

location_facility: The Ohio State University Medical Center

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: Ohio State University Imaging at Martha Morehouse

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: The Ohio State University Hospitals Clinic

location_facility: Saint-Petersburg State institution of healthcare, City geriatric medico-social center

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Four Rivers Clinical Research, Incorporated

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Institutional Review Board / Ethics Committee

location_facility: Investigational New Drug Services, IDS Pharmacy

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: Carolina Neuropsychological Services, Inc.

location_facility: University of Virginia General Clinical Research Center

location_facility: Klinik fur Psychiatrie und Psychotherapie

location_facility: Seoul National University Bundang Hospital, Department of Psychiatry

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: Kansai Medical University Takii Hospital

location_facility: University of North Texas Health Science Center

location_facility: Southern Illinois University School of Medicine

location_facility: Hospital of the University of Pennslyvania

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: McCusker Alzheimer's Research Foundation Inc.

location_facility: Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko

location_facility: The clinic: Minnes- och geriatrikmottagningen

location_facility: Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: Nippon Medical School Musashikosugi Hospital

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers


title: A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

ReferenceCitation: Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.

family: Schwartz

full_name: Gregory G. Schwartz

given: Gregory G.

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

family: Ballantyne

full_name: Christie M. Ballantyne

given: Christie M.

family: Barter

full_name: Philip J. Barter

given: Philip J.

full_name: Donald M. Black

given: Donald M.

family: Kallend

full_name: David Kallend

given: David

family: Laghrissi-Thode

full_name: Fouzia Laghrissi-Thode

given: Fouzia

family: Leitersdorf

full_name: Eran Leitersdorf

given: Eran

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

family: Olsson

full_name: Anders G. Olsson

given: Anders G.

family: Preiss

full_name: David Preiss

family: Shah

full_name: Prediman K. Shah

given: Prediman K.

family: Tardif

full_name: Jean-Claude Tardif

given: Jean-Claude

family: Kittelson

full_name: John Kittelson

given: John

journal_name: Diabetes Care

oa_colors: green other

license: implied-oa

license_normalized: implied-oa

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

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16.

family: Salahuddin

full_name: Taufiq Salahuddin

ReferenceCitation: Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833.

name: Cardiology Section, Veterans Affairs Medical Center and University of Colorado School of Medicine, Denver

name: Division of Atherosclerosis and Vascular Medicine, Baylor College of Medicine, Houston, Texas

name: School of Medical Sciences, University of New South Wales, Sydney, New South Wales, Australia

name: The Medicines Company, Zurich, Switzerland

name: Division of Endocrinology and Metabolism, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Keenan Research Centre for Biomedical Science, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Department of Medicine, Hadassah Hebrew University Medical Center, Jerusalem, Israel

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland

name: South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia

name: Department of Medicine and Health, Linköping University, Linköping, Sweden

name: Cedars-Sinai Heart Institute, Los Angeles, California

name: Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada

ReferenceCitation: Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1). pii: e004119. doi: 10.1161/JAHA.116.004119.

name: Cardiology Section, VA Medical Center and University of Colorado School of Medicine, Denver, CO

name: University of Colorado School of Public Health, Aurora, CO

name: University of New South Wales, Sydney, Australia

name: Division of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St Michael's Hospital, University of Toronto, Canada

name: South Australian Health and Medical Research Institute, University of Adelaide, Australia

name: Cedars‐Sinai Heart Institute, Los Angeles, CA

name: Montreal Heart Institute, Université de Montréal, Canada

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Australian Catholic University - Research Bank

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boulé M, Alem S, Grégoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rhéaume E, Dubé MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

name: From the Montreal Heart Institute (J.-C.T., D.R., M. Brodeur, M. Boulé, S.A., J.C.G., P.L.L., R.I., E.R., M.-P.D.), Université de Montréal, Faculty of Medicine (J.-C.T., J.C.G., P.L.L., R.I., E.R., M.-P.D.), Université de Montréal Beaulieu-Saucier Pharmacogenomics Center (Y.F.Z., R.F., S.P., I.M., M.-P.D.), Montreal Health Innovations Coordinating Center (MHICC) (M.-C.G.), Montreal, Canada; Linkoping University, Department of Medicine and Health, Stockholm, Sweden (A.G.O.); and Veterans Affairs...

ReferenceCitation: Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544. Erratum in: J Am Coll Cardiol. 2015 Jul 21;66(3):334.

title: Fasting Triglycerides Predict Recurrent Ischemic Events in Patients With Acute Coronary Syndrome Treated With Statins

ReferenceCitation: Tardif JC, Rhéaume E, Lemieux Perreault LP, Grégoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dubé MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

name: Montreal Heart Institute (J.-C.T., E.R., L.-P.L.P., J.C.G., Y.F.Z., G.A., S.P., A.B., D.R., P.L.L’., R.I., M.-C.G., I.M., M.-P.D.), Université de Montréal (J.-C.T., E.R., J.C.G., P.L.L’., R.I., M.-P.D.), Université de Montréal Beaulieu-Saucier Pharmacogenomics, Centre Montreal, Quebec, Canada (L.-P.L.P., Y.F.Z., G.A., S.P., A.B., I.M., M.-P.D.), Montreal Health Innovations Coordinating Centre (MHICC) (M.-C.G.), Montreal, Quebec, Canada; Stockholm Heart Center, Stockholm, Sweden (A.G.O.); Veterans...

title: Pharmacogenomic Determinants of the Cardiovascular Effects of Dalcetrapib

ReferenceCitation: Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.

repository_institution: The University of Queensland - Queensland's institutional digital repository

title: Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome

ReferenceCitation: Lüscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Münzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

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

ReferenceCitation: Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342.

title: No clinically relevant drug–drug interactions when dalcetrapib is co-administered with atorvastatin

ReferenceCitation: Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.

title: Rationale and design of the dal-OUTCOMES trial: Efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome

ReferenceCitation: Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.

title: Safety and Tolerability of Dalcetrapib††Conflicts of interest: Dr. Stein has received grants for studies of lipid-modifying agents, has received consulting fees and honoraria for professional input regarding agents to modify lipid profile, and/or has delivered lectures for the American Association for Clinical Chemistry, Washington, District of Columbia; Abbott Laboratories, Abbott Park, Illinois; AstraZeneca, Wilmington, Delaware; the United States Food and Drug Administration, Washington, District of Columbia; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Isis Pharmaceuticals, Inc., Carlsbad, California; Merck & Co., Whitehouse Station, New Jersey; the National Lipid Association, Jacksonville, Florida; Novartis International AG, Basel Switzerland; Reliant Pharmaceuticals, Inc., Liberty Corner, New Jersey; Daiichi Sankyo Co., Ltd., Tokyo, Japan; Schering-Plough Corporation, Kenilworth, New Jersey; Takeda Pharmaceutical Company Ltd., Osaka, Japan; and Wyeth, Madison, New Jersey. Dr. Stroes has received consulting fees and honoraria from F. Hoffmann-La Roche Ltd. and Novartis International AG. Dr. Steiner has received consulting fees and honoraria from F. Hoffmann-La Roche Ltd.; Solvay, Brussels, Belgium; Ethypharm S.A., Saint-Cloud, France; and Merck Frosst Canada Ltd. (Kirkland, Quebec, Canada)/Schering-Plough Corporation. Dr. Buckley has received research grants from AstraZeneca; Merck Sharp & Dohme, Dublin, Ireland; and Pfizer, Inc., New York, New York. Dr. Buckley has received honoraria and consulting fees and/or delivered lectures for AstraZeneca; Bristol-Myers Squibb, New York, New York; F. Hoffmann-La Roche Ltd.; Novartis International AG; Pfizer, Inc.; and Sanofi-Aventis, Paris, France. Dr. Capponi has received consulting fees and honoraria from F. Hoffmann-La Roche Ltd. Dr. Burgess is an employee of Hoffmann-La Roche Inc., Nutley, New Jersey. Drs. Niesor and Kallend are employees of F. Hoffmann-La Roche Ltd. Dr. Kastelein has received research grants, honoraria, or consulting fees for professional input and/or has delivered lectures for Pfizer, Inc.; Merck Sharp & Dohme; F. Hoffmann-La Roche Ltd.; Novartis International AG; Isis Pharmaceuticals, Inc.; Kowa Pharmaceutical Company Ltd., Nagoya, Japan; Schering-Plough Corporation; and AstraZeneca.

location_country:
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