title: An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

summary: This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 500 individuals.

design_allocation: Non-Randomized

location_country:
Poland
Portugal
Saudi Arabia
Greece
Italy
Australia
Spain
Canada
Czech Republic
United Kingdom
Hungary
France
Romania
Netherlands


title: A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).

summary: A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, Chen TY, Kluetz PG. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. Clin Trials. 2022 Jun;19(3):267-273. doi: 10.1177/17407745221093935. Epub 2022 May 15.

ReferenceCitation: Singh J, Bourke S, Dyer M, Devlin N, Longworth L. An Analysis of 5-Level Version of EQ-5D Adjusting for Treatment Switching: The Case of Patients With Epidermal Growth Factor Receptor T790M-Positive Nonsmall Cell Lung Cancer Treated With Osimertinib. Value Health. 2022 Jul;25(7):1205-1211. doi: 10.1016/j.jval.2022.01.022. Epub 2022 Apr 2.

ReferenceCitation: Papadimitrakopoulou VA, Mok TS, Han JY, Ahn MJ, Delmonte A, Ramalingam SS, Kim SW, Shepherd FA, Laskin J, He Y, Akamatsu H, Theelen WSME, Su WC, John T, Sebastian M, Mann H, Miranda M, Laus G, Rukazenkov Y, Wu YL. Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis. Ann Oncol. 2020 Nov;31(11):1536-1544. doi: 10.1016/j.annonc.2020.08.2100. Epub 2020 Aug 27.

ReferenceCitation: Papadimitrakopoulou VA, Han JY, Ahn MJ, Ramalingam SS, Delmonte A, Hsia TC, Laskin J, Kim SW, He Y, Tsai CM, Hida T, Maemondo M, Kato T, Jenkins S, Patel S, Huang X, Laus G, Markovets A, Thress KS, Wu YL, Mok T. Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum-pemetrexed for T790M mutation-positive advanced non-small cell lung cancer. Cancer. 2020 Jan 15;126(2):373-380. doi: 10.1002/cncr.32503. Epub 2019 Nov 26.

ReferenceCitation: Wu YL, Ahn MJ, Garassino MC, Han JY, Katakami N, Kim HR, Hodge R, Kaur P, Brown AP, Ghiorghiu D, Papadimitrakopoulou VA, Mok TSK. CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non-Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3). J Clin Oncol. 2018 Sep 10;36(26):2702-2709. doi: 10.1200/JCO.2018.77.9363. Epub 2018 Jul 30.

ReferenceCitation: Lee CK, Novello S, Rydén A, Mann H, Mok T. Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial. J Clin Oncol. 2018 Jun 20;36(18):1853-1860. doi: 10.1200/JCO.2017.77.2293. Epub 2018 May 7.

ReferenceCitation: Akamatsu H, Katakami N, Okamoto I, Kato T, Kim YH, Imamura F, Shinkai M, Hodge RA, Uchida H, Hida T. Osimertinib in Japanese patients with EGFR T790M mutation-positive advanced non-small-cell lung cancer: AURA3 trial. Cancer Sci. 2018 Jun;109(6):1930-1938. doi: 10.1111/cas.13623. Epub 2018 May 31.

ReferenceCitation: Mok TS, Wu Y-L, Ahn M-J, Garassino MC, Kim HR, Ramalingam SS, Shepherd FA, He Y, Akamatsu H, Theelen WS, Lee CK, Sebastian M, Templeton A, Mann H, Marotti M, Ghiorghiu S, Papadimitrakopoulou VA; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640. doi: 10.1056/NEJMoa1612674. Epub 2016 Dec 6.

ReferenceCitation: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

ipd_sharing: Yes

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.

lead_sponsor: AstraZeneca

location_country:
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Sweden
Hungary
Korea, Republic of
United States
France
China
Mexico
Japan
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

acronym: GARDENIA

intervention_type: Other

title: Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

study_completion_date_type: Actual

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

ReferenceCitation: Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6. Epub 2021 Nov 17.

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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:
Portugal
Romania
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Sweden
Hungary
Korea, Republic of
France
Israel
Singapore
South Africa
Belgium
Norway
Germany
Czechia

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

location_facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Universitair Ziekenhuis Brussel; Neurology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

summary: This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.

status_simplified: Completed


title: A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

lead_sponsor: Pfizer

type: Other Identifier

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

location_country:
Spain
Greece
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of California, San Francisco Medical Center

location_facility: Emory University, Winship Cancer Institute

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Hospital Clinico Universitario de Valencia

location_facility: TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I

location_facility: NY Presbyterian - Weill Cornell Medical Center

location_facility: General Hospital of Athens "Evangelismos"

summary:
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.

Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.


title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

ReferenceType: background

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

ReferenceCitation: Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.

ipd_sharing: Undecided

lead_sponsor: Symphogen A/S

location_country:
Poland
Spain
Italy
Austria
Russian Federation
Hungary
United States
France
Belgium
Germany

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Seconda Università degli Studi di Napoli

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie


title: Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

summary:
180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

ReferenceCitation: Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15.

lead_sponsor: Galapagos NV

location_country:
Poland
Romania
United Kingdom
Russian Federation
Czech Republic
Hungary
France
Belgium
Germany

location_facility: Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults

location_facility: Outpatient Clinic of Internal Medicine and Gastroenterology

location_facility: Vladimirsky Regional Clinical Research Institute

location_facility: Lille Regional University Hospital Center

location_facility: Mechnikov North-Western State Medical University

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: Institute of Clinical and Experimental Medicine

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Saint Etienne University Hospital Center

location_facility: Internal Medicine Group Practice Oldenburg

location_facility: Semashko Nizhny Novgorod Regional Clinical Hospital

location_facility: Clinical Hospital of Ministry of Internal Affairs and Administration


acronym: BIRCH

title: A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

location_country:
Bosnia and Herzegovina
Hong Kong
Slovenia
Italy
Georgia
Australia
Netherlands
Canada
Spain
Switzerland
United Kingdom
United States
France
Singapore
Turkey
Belgium
Japan
Germany
Bulgaria

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Washington University School of Medicine

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Uni of Maryland; Greenebaum Cancer Center

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Yokohama Municipal Citizen'S Hospital; Respiratory Medicine

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Toranomon Hospital; Respiratory Medicine

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

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

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: National Cancer Centre; Medical Oncology

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: Kitasato University Hospital; Respiratory Medicine

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Specialized Hospital for Active Treatment of Oncology

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: University of Virginia; Office of Sponsored Programs

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: University Clinical Center Sarajevo;Institute of oncology

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Ege University School of Medicine; Chest Diseases Department

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Research institute for Clinical Medicine

location_facility: Hopital Arnaud De Villeneuve; Maladies Respiratoires

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

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

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: University Clinical Center Sarajevo;Clinic for Pulmonary disease

location_facility: Ankara Ataturk Chest Diseases Training and Research Hospital

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Georgetown University Medical Center Lombardi Cancer Center

summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Greece
Latvia
Russian Federation
Canada
Hungary
United States
France
Mexico
Germany


title: A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors

summary: This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

status: Terminated

lead_sponsor: Amgen

location_country:
Poland
Spain
Greece
Austria
Australia
Italy
Canada
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
Chile
France
Peru
Belgium
Germany
Czechia

status_simplified: Unknown


title: A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

lead_sponsor: MedImmune LLC

ReferenceCitation: Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.

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

summary: The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).


title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).

summary: This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.

lead_sponsor: Eisai Limited

location_country:
Denmark
Spain
Italy
Austria
United Kingdom
Sweden
France
Germany


title: EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease

acronym: EPIDEPSO

summary: The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Spain
Ireland
Austria
Greece
Russian Federation
United Kingdom
France
Israel
South Africa
Belgium
Norway
Netherlands


title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

summary: An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

ReferenceCitation: Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Spain
Italy
Austria
Ireland
United Kingdom
Sweden
France
Germany

location_facility: 1160.85.04916 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04946 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4805 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4312 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04918 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04948 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3302A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3324A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4304 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04947 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3321A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4309 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04934 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04941 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3306A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04928 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3322A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3313A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.35301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3310A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04943 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04944 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04922 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3402 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04945 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3320A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04930 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3315A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3319A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3309A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4603 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04920 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04927 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04917 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3311A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04949 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3331A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4802 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04939 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4308 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04910 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3325A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4601 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04940 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3304A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04932 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4803 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04907 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04402 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04904 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04926 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3333A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4806 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03910 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04923 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4804 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3314A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04906 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4303 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03911 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04909 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04931 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04406 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3318A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4311 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04952 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04921 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03907 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04933 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4302 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3317A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4305 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3406 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04929 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04935 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4307 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3407 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04912 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3303A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3334A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3308A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04915 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03906 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04404 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3307A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04924 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3323A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04936 Boehringer Ingelheim Investigational Site


title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)

lead_sponsor: Ferring Pharmaceuticals

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.

ReferenceCitation: Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.

location_country:
Spain
Greece
United Kingdom
Netherlands
United States
France
Germany

location_facility: DCT -Celebration, LLC dba Discovery Clinical Trials

location_facility: Albert Schweitzer Ziekenhuis, Ioc., Dordwijk

location_facility: Hôpital Saint Louis, Radiotherapy Departement

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: CRLC Val d'Aurelle Oncology Radiotherapy

location_facility: Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie

location_facility: Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre

location_facility: University General Hospital of Loannina, Medical School

location_facility: Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie

location_facility: Northern Centre for Cancer Treatment, Newcastle General Hospital

location_facility: Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie

location_facility: General University Hospital of Alexandroupolis

location_facility: Oncology Royal United Hospital Bath NHS Trust

location_facility: General Hospital of Athens, "Sismanogleio", University of Athens, Marouse

summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


acronym: RELY-ABLE

title: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

ReferenceCitation: Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.

location_country:
United Kingdom
Italy
United States
Belgium
Philippines
Romania
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
India
Israel
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Finland
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

location_facility: 1160.71.1673 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1169 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0187 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.874A Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0480 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0133 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0315 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0816 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1586 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0692 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1682 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0213 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0431 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.880B Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0725 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0317 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.884A Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0542 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0673 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0422 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0333 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0904 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1501 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0360 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0478 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0142 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1671 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1121 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0433 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1741 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1072 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0064 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1070 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0705 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0784 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0047 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0832 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1356 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1425 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0001 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0349 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0346 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0150 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0833 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0615 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0255 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0813 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0541 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1432 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1349 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0709 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0944 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1626 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0006 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0578 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0129 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1745 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0274 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0119 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0410 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1503 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0295 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1341 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0084 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0445 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1755 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0284 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0940 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1117 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0178 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1472 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1513 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1111 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0281 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0024 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1172 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0376 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1057 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0293 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0208 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0035 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0694 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0384 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0156 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1350 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1065 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1394 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0836 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0701 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0086 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1397 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0263 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0778 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0356 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0203 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1107 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0970 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1674 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0367 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0585 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1421 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1091 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1652 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.880A Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1744 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0096 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.880J Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1543 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0104 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0780 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0838 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1112 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.882A Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0018 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1635 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.879B Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0617 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0012 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0132 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0612 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0221 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1018 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0814 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0839 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1354 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0710 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0465 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0414 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1679 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1751 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1056 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0625 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0962 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0931 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1678 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0369 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0643 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0443 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1676 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0652 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1338 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0479 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0549 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0308 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0257 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1331 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0466 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1582 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1105 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.1681 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1512 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0966 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0198 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1624 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1422 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1116 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0021 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0451 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0675 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0229 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.879H Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0080 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1509 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0510 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.882H Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0279 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0302 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1095 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1511 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0002 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0435 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0110 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0103 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1119 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0901 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0618 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0547 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0644 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0072 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0099 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0650 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0611 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0003 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0434 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0449 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0696 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0571 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0075 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1438 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1505 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1014 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1067 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0177 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0452 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0561 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0201 Boehringer Ingelheim Investigational Site

summary:
The purposes of this study are:

To evaluate the long-term safety of dabigatran etexilate
To assess the effect of a knowledge translation intervention on patient outcomes


acronym: STABILITY

title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Sjölin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15.

ReferenceCitation: Held C, Hadziosmanovic N, Aylward PE, Hagström E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. Epub 2022 Jan 21.

ReferenceCitation: Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2022 Jan;65(1):101-112. doi: 10.1007/s00125-021-05574-5. Epub 2021 Sep 25.

ReferenceCitation: Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagström E, Held C, Kleber ME, Koenig W, März W, Stewart RAH, White HD, Åberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.

ReferenceCitation: White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.

ReferenceCitation: Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylhä A, Lindbäck J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7.

ReferenceCitation: Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641.

ReferenceCitation: Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Östlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10). pii: e005077. doi: 10.1161/JAHA.116.005077.

ReferenceCitation: Hagström E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, López-Sendón J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.

ReferenceCitation: Guimarães PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagström E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9). pii: e006695. doi: 10.1161/JAHA.117.006695.

ReferenceCitation: Stewart RAH, Hagström E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, López-Sendón JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8). pii: e006096. doi: 10.1161/JAHA.117.006096.

ReferenceCitation: Lindholm D, Lindbäck J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagström E, Held C, Koenig W, Östlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, März W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.

ReferenceCitation: Vedin O, Hagström E, Östlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.

ReferenceCitation: Hagström E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Östlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.

ReferenceCitation: Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagström E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Östlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6). pii: e003407. doi: 10.1161/JAHA.116.003407.

ReferenceCitation: Hijazi Z, Lindbäck J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.

ReferenceCitation: Vedin O, Hagström E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16.

ReferenceCitation: Vedin O, Hagström E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10.

ReferenceCitation: STABILITY Investigators, White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, López-Sendón J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.

ReferenceCitation: Vedin O, Hagström E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.

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:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands
Pakistan

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.