title: A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension

acronym: REGAIN CONTROL

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS).
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

name: Institute of General Practice and Evidence-Based Health Services Research; Medical University of Graz; Graz Austria

family: Semlitsch

full_name: Thomas Semlitsch

given: Thomas

name: Institute for General Practice; Goethe University; Frankfurt am Main Germany

family: Engler

full_name: Jennifer Engler

given: Jennifer

name: Institute of General Practice and Evidence-Based Health Services Research, Medical University of Graz; Graz, Austria / Institute of General Practice, Goethe University; Frankfurt am Main Austria

family: Siebenhofer

full_name: Andrea Siebenhofer

given: Andrea

name: Institute of General Practice and Evidence-Based Health Services Research / Institute for Medical Informatics, Statistics and Documentation; Medical University of Graz; Graz Austria

family: Jeitler

full_name: Klaus Jeitler

given: Klaus

family: Berghold

full_name: Andrea Berghold

name: Institute of General Practice and Evidence-Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism; Medical University of Graz; Graz Austria

family: Horvath

full_name: Karl Horvath

given: Karl

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyên-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

name: Institute of Clinical Trials and Methodology, University College London, London, UK;

family: Freemantle

full_name: Nick Freemantle

given: Nick

name: Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau, CIBERDEM, Barcelona, Spain;

family: Mauricio

full_name: Didac Mauricio

given: Didac

name: Center for Endocrine and Metabolic Diseases, Fondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy;

family: Giaccari

full_name: Andrea Giaccari

family: Bailey

full_name: Timothy Bailey

given: Timothy

name: Department of Diabetology, Endocrinology, and Nutrition, Bichat Hospital, AP-HP, Paris, France;

name: INSERM U1138, Centre de Recherche des Cordeliers, Paris, France;

name: UFR de Médecine, Paris University, Paris, France;

family: Roussel

full_name: Ronan Roussel

given: Ronan

name: CPCLIN Clinical Research Center, São Paulo, Brazil;

family: Franco

full_name: Denise Franco

given: Denise

family: Berthou

full_name: Baptiste Berthou

given: Baptiste

family: Pilorget

full_name: Valerie Pilorget

given: Valerie

family: Westerbacka

full_name: Jukka Westerbacka

given: Jukka

family: Bosnyak

full_name: Zsolt Bosnyak

given: Zsolt

family: Bonnemaire

full_name: Mireille Bonnemaire

given: Mireille

family: Cali

full_name: Anna M. G. Cali

given: Anna M. G.

family: Nguyên-Pascal

full_name: My-Liên Nguyên-Pascal

given: My-Liên

name: Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes and Université Paris Sud, Paris, France;

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

name: Servei d´Endocrinologia i Nutrició, Hospital Universitari Bellvitge, L’Hospitalet de Llobregat, IDIBELL, Barcelona, Spain;

name: Faculty of Medicine, Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, University of Freiburg, Freiburg, Germany;

name: The CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA;

name: Obesity and Endocrinology Clinical Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK;

name: Diabetes and Endocrinology Center, Multicare Rockwood Clinic, Spokane, WA, USA;

name: Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK

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

repository_institution: University College London - UCL Discovery

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
Italy
Brazil
Switzerland
Finland
France
Greece
Romania
Ireland
Spain
United Kingdom

location_facility:
Investigational Site Number 380031
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Investigational Site Number 642002
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Investigational Site Number 380011
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Investigational Site Number 380001
Investigational Site Number 642003
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Investigational Site Number 380004
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Investigational Site Number 300002
Investigational Site Number 724023
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Investigational Site Number 724019
Investigational Site Number 372003
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Investigational Site Number 380025
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Investigational Site Number 250011
Investigational Site Number 250008
Investigational Site Number 724024
Investigational Site Number 380017
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Investigational Site Number 300003
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Investigational Site Number 826008
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Investigational Site Number 380002
Investigational Site Number 246002
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Investigational Site Number 076009
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Investigational Site Number 380014
Investigational Site Number 826023
Investigational Site Number 756002
Investigational Site Number 380015


design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

enrollment_type: Actual

primary_purpose: Treatment

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

location_facility: St. Louis University Cancer Center - Hematology/Oncology

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: Robert H. Lurie Comprehensive Cancer Center

location_facility: University of California, Irvine Medical Center

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

summary:
This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.

For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster.

This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Bourlière M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Lédinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.

family: Bourlière

full_name: Marc Bourlière

given: Marc

sequence: first

family: Gordon

full_name: Stuart C. Gordon

given: Stuart C.

sequence: additional

family: Flamm

full_name: Steven L. Flamm

given: Steven L.

family: Cooper

full_name: Curtis L. Cooper

given: Curtis L.

family: Ramji

full_name: Alnoor Ramji

given: Alnoor

family: Tong

full_name: Myron Tong

given: Myron

family: Ravendhran

full_name: Natarajan Ravendhran

given: Natarajan

family: Vierling

full_name: John M. Vierling

given: John M.

family: Tran

full_name: Tram T. Tran

given: Tram T.

family: Pianko

full_name: Stephen Pianko

given: Stephen

family: Bansal

full_name: Meena B. Bansal

given: Meena B.

family: de Lédinghen

full_name: Victor de Lédinghen

given: Victor

family: Hyland

full_name: Robert H. Hyland

given: Robert H.

family: Stamm

full_name: Luisa M. Stamm

given: Luisa M.

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Zhang

full_name: Jie Zhang

given: Jie

family: Huang

full_name: K.C. Huang

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Verna

full_name: Elizabeth C. Verna

given: Elizabeth C.

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Landis

full_name: Charles S. Landis

given: Charles S.

family: Younes

full_name: Ziad H. Younes

given: Ziad H.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

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

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

summary: The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.


title: A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

summary: Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Sun Pharma Advanced Research Company Limited

location_country:
Italy
India
France
Romania
Hungary
Belgium
Singapore
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Memorial Sloan Kettering Cancer Center - MAIN

location_facility: ICO Girona - Hospital Universitari de Girona Dr Josep Trueta

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Huntsman Cancer Institute University of Utah

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: CHU de Nancy - Hôpital de Brabois Adultes

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Ferrarotto Alessi)

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

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

location_facility: The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute

location_facility: Board of Regents of the University System of Georgia


ReferenceCitation: Moehler M, Dvorkin M, Boku N, Özgüroğlu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coşkun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.

name: Department of Internal Medicine, Johannes-Gutenberg University, Mainz, Germany

family: Moehler

full_name: Markus Moehler

given: Markus

name: Department of Oncology, Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary, Omsk, Russian Federation

family: Dvorkin

full_name: Mikhail Dvorkin

given: Mikhail

name: National Cancer Center Hospital, Tokyo, Japan

family: Boku

full_name: Narikazu Boku

given: Narikazu

name: Clinical Trial Unit, Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul, Turkey

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

family: Ryu

full_name: Min-Hee Ryu

given: Min-Hee

name: Department of Research, Oncology Institute Prof Dr Ion Chiricuţă, Cluj Napoca, Romania

family: Muntean

full_name: Alina S. Muntean

given: Alina S.

name: Dipartimento di Oncologia Clinica e Sperimentale, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy

family: Lonardi

full_name: Sara Lonardi

given: Sara

name: Arkhangelsk Clinical Oncological Dispensary, State Budgetary Healthcare Institution of Arkhangelsk Region, Arkhangelsk, Russian Federation

family: Nechaeva

full_name: Marina Nechaeva

given: Marina

name: Hospital de Câncer de Barretos-Fundação Pio XII, São Paulo, Brazil

family: Bragagnoli

full_name: Arinilda C. Bragagnoli

given: Arinilda C.

name: Department of Medical Oncology, Akdeniz University Medical Faculty, Antalya, Turkey

family: Coşkun

full_name: Hasan S. Coşkun

given: Hasan S.

name: Hospital Universitario HM Sanchinarro, Madrid, Spain

name: CEU Universidad San Pablo, Madrid, Spain

family: Cubillo Gracian

full_name: Antonio Cubillo Gracian

given: Antonio

family: Takano

full_name: Toshimi Takano

given: Toshimi

name: Eastern Health, Box Hill Hospital, Monash University, Melbourne, Victoria, Australia

family: Wong

full_name: Rachel Wong

given: Rachel

name: Rhode Island Hospital, Brown University, Providence, RI

family: Safran

full_name: Howard Safran

given: Howard

name: Oregon Health & Science University, Portland, OR

family: Vaccaro

full_name: Gina M. Vaccaro

given: Gina M.

name: Ronald Reagan University of California Los Angeles Medical Center, Santa Monica, CA

family: Wainberg

full_name: Zev A. Wainberg

given: Zev A.

name: EMD Serono Research & Development Institute, Inc, Billerica, MA; an affiliate of Merck KGaA, Darmstadt, Germany

family: Silver

full_name: Matthew R. Silver

given: Matthew R.

family: Xiong

full_name: Huiling Xiong

given: Huiling

family: Hong

full_name: Janet Hong

given: Janet

name: Department of Gastroenterology and Digestive Oncology, Georges-Pompidou European Hospital, Assistance Publique–Hôpitaux de Paris, Université de Paris, Paris, France

family: Taieb

full_name: Julien Taieb

given: Julien

name: Seoul National University Hospital, Seoul, Republic of Korea

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

intervention_type: Other

status: Completed

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Brazil
United States
Germany
France
Japan
Thailand
Romania
Hungary
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: SBIH " Clinical Oncological Dispensary # 1"

location_facility: Seconda Università degli Studi di Napoli

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: Konya Necmettin Erbakan University Meram Medical Faculty

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: Saitama Medical University International Medical Center

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kyungpook National University Medical Center

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Seoul National University Bundang Hospital

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Adana Numune Training and Research Hospital

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

location_facility: Trio - Central Coast Medical Oncology Corporation

location_facility: University of Texas Health Science Center at San Antonio

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: Franciscan St. Francis Health Cancer Center

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: IMV - Instituto De Medicina Vascular Hospital Mae de Deus

location_facility: University of Texas Southwestern Medical Center

title: A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction

summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.


title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial

acronym: SECURE

summary: The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

primary_purpose: Prevention

ReferenceCitation: Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.

name: Department of Dermatology, Venerology, and Allergology, Charité – University Medicine Berlin, Berlin, Germany

name: Department of Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Berlin, Germany

family: Buttgereit

full_name: Thomas Buttgereit

given: Thomas

family: Palmowski

full_name: Andriko Palmowski

given: Andriko

family: Forsat

full_name: Noah Forsat

given: Noah

name: Department of Rheumatology, Amsterdam Rheumatology & Immunology Center, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, The Netherlands

name: Department of Epidemiology & Data Science, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, The Netherlands

family: Boers

full_name: Maarten Boers

given: Maarten

name: AGE Research Group, NIHR Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle upon Tyne Hospitals Trust, UK

family: Witham

full_name: Miles D Witham

given: Miles D

name: Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

name: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland

family: Rodondi

full_name: Nicolas Rodondi

given: Nicolas

family: Moutzouri

full_name: Elisavet Moutzouri

given: Elisavet

name: Clinical Trials Coordination Unit (UCEC), CNIC – Spanish National Center for Cardiovascular Research, Madrid, Spain

family: Navidad

full_name: Antonio Jesus Quesada Navidad

given: Antonio Jesus Quesada

name: Department of Cardiology, University Medical Center Maastricht, Maastricht, The Netherlands

family: van’t Hof

full_name: Arnoud W J van’t Hof

given: Arnoud W J

name: Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands

family: van der Worp

full_name: Bart van der Worp

given: Bart

name: Fundació Salut i Envelliment-Universitat Autònoma de Barcelona, Barcelona, Spain

family: Coll-Planas

full_name: Laura Coll-Planas

given: Laura

name: Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands

family: Voshaar

full_name: Marieke Voshaar

given: Marieke

name: Patient Research Partner, VU Medical Center, Amsterdam, The Netherlands

family: de Wit

full_name: Maarten de Wit

name: Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

family: da Silva

full_name: José da Silva

given: José

name: Institute of Process and Particle Engineering , Graz University of Technology, Graz, Austria

family: Stegemann

full_name: Sven Stegemann

given: Sven

name: Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands

family: Bijlsma

full_name: Johannes W Bijlsma

given: Johannes W

name: Department Acute Geriatric Care, Faculty of Geriatric Medicine, Medical University of Vienna, Vienna, Austria

family: Koeller

full_name: Marcus Koeller

given: Marcus

name: Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Institute for Evidence-based Medicine in Old Age|IEMO, Leiden, The Netherlands

family: Mooijaart

full_name: Simon Mooijaart

given: Simon

name: School of Epidemiology and Public Health, University College Cork, Cork, Ireland

family: Kearney

full_name: Patricia M Kearney

given: Patricia M

full_name: Frank Buttgereit

given: Frank

journal_name: Age and Ageing

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Barriers and potential solutions in the recruitment and retention of older patients in clinical trials—lessons learned from six large multicentre randomized controlled trials

lead_sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

location_country: Italy France Czechia Poland Hungary Spain Germany

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Hospital Universitario Reina Sofia de Cordoba

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Presidio Ospedaliero San Filippo Neri-ASL Roma E

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: IRCCS Fondazione S. Maugeri Istit. di Cassano Murge

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Hospital Clinic Universitari de Valencia

location_facility: Gesundheitszentrum Bitterfeld /Wolfen GmbH

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy

location_facility: Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

location_facility: ASL FG Ospedale "Teresa Masselli Mascia"

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego

location_facility: Ospedale Ss Giovanni di Dio e Ruggi d'Aragona

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Hospital Universitario Principe de Asturias

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Centrum Kardiologiczne "Pro Corde" Sp. z o.o.

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: ASST Di Monza-Presidio Ospedaliero di Desio

location_facility: ASST Della Valle Olona-Ospedale di Saronno

location_facility: ASST di Bergamo Ovest-Ospedale di Treviglio

location_facility: Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu

location_facility: Klinik am See, Rehabilitationszentrum für innere Medizin

location_facility: Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)

location_facility: Centre Hospitalier Régional et Universitaire de Lille

location_facility: Ospedale Generale di Zona-Ospedale Valduce

location_facility: ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.

location_facility: AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli

location_facility: Fejér Megyei Szent György Egyetemi Kórház

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Ospedale Bolognini di Seriate - ASST BERGAMO EST


title: A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

acronym: dal-GenE

summary: A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

ReferenceCitation: Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.

family: Black

full_name: Donald M. Black

given: Donald M.

family: Miller

full_name: Michael Miller

given: Michael

family: Heinonen

full_name: Therese M. Heinonen

given: Therese M.

family: Zhang

full_name: Guili Zhang

given: Guili

journal_name: Journal of Cardiovascular Pharmacology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Advancing Beyond Failed HDL Clinical Trials to Pharmacogenetic Studies of ADCY9 and CETP inhibition

ReferenceCitation: Tardif JC, Dubé MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.

family: Tardif

full_name: Jean-Claude Tardif

given: Jean-Claude

family: Dubé

full_name: Marie-Pierre Dubé

given: Marie-Pierre

family: Pfeffer

full_name: Marc A. Pfeffer

given: Marc A.

family: Waters

full_name: David D. Waters

given: David D.

family: Koenig

full_name: Wolfgang Koenig

given: Wolfgang

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Mooser

full_name: Vincent Mooser

given: Vincent

family: White

full_name: Harvey D. White

given: Harvey D.

full_name: Therese Heinonen

given: Therese

family: Guertin

full_name: Marie-Claude Guertin

given: Marie-Claude

journal_name: American Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

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

host_type: repository

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

repository_institution: California Digital Library - eScholarship

repository_institution: The University of Glasgow - Enlighten: Publications

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Argentina
Canada
South Africa
Chile
Sweden
United Arab Emirates
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

location_facility:
Institut de Cardiologie de Montreal
Research Site


ReferenceCitation: Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Hussain

full_name: Maha Hussain

given: Maha

family: Gschwend

full_name: Jürgen E Gschwend

given: Jürgen E

family: Albers

full_name: Peter Albers

given: Peter

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Daneshmand

full_name: Siamak Daneshmand

given: Siamak

family: Nishiyama

full_name: Hiroyuki Nishiyama

given: Hiroyuki

family: Majchrowicz

full_name: Martin Majchrowicz

given: Martin

family: Degaonkar

full_name: Viraj Degaonkar

given: Viraj

family: Shi

full_name: Yi Shi

given: Yi

family: Mariathasan

full_name: Sanjeev Mariathasan

given: Sanjeev

family: Grivas

full_name: Petros Grivas

given: Petros

family: Drakaki

full_name: Alexandra Drakaki

given: Alexandra

family: O'Donnell

full_name: Peter H O'Donnell

given: Peter H

family: Rosenberg

full_name: Jonathan E Rosenberg

given: Jonathan E

family: Geynisman

full_name: Daniel M Geynisman

given: Daniel M

family: Petrylak

full_name: Daniel P Petrylak

given: Daniel P

family: Hoffman-Censits

full_name: Jean Hoffman-Censits

given: Jean

family: Bedke

full_name: Jens Bedke

given: Jens

family: Kalebasty

full_name: Arash Rezazadeh Kalebasty

given: Arash Rezazadeh

family: Zakharia

full_name: Yousef Zakharia

given: Yousef

family: van der Heijden

full_name: Michiel S van der Heijden

given: Michiel S

family: Sternberg

full_name: Cora N Sternberg

given: Cora N

family: Davarpanah

full_name: Nicole N Davarpanah

given: Nicole N

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Switzerland
Netherlands
China
United States
Germany
United Kingdom
Italy
Serbia
Czechia
Israel
Spain
Turkey

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: SpecjalistycznySzpital Miejski w Toruniu; Oddział Urologii Ogólnej i Onkologicznej

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: National Cancer Center Hospital; Urology

location_facility: SBEI of HPE "Bashkir State Medical University" of MoH RF

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Diakonie-Klinikum Stuttgart; Urologische Klinik

location_facility: University Hospital of Patras Medical Oncology

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: The Ohio State University Wexner Medical Center

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: University of Chicago; Hematology/Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Tampere University Hospital; Dept Of Urology

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Turku University Central Hospital; Urology clinic

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Az. Osp. Cardarelli; Divisione Di Oncologia

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Friendship Hospital, Capital Medical University

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: Wake Forest University Baptist Medical Center

location_facility: Austin and Repatriation Medical Centre; Cancer Services

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

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Rambam Health Care Campus; Oncology - Hafia

location_facility: GU "Institution of urology of Academy Medical science of Ukraine"

location_facility: Helsinki University Central Hospital; Urology Clinics

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Universitätsmedizin Rostock, Urologische Klinik und Poliklinik

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Albert B. Chandler Medical Center; University of Kentucky

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: University Hospital Motol; Department of Urology

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

location_facility: Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii

location_facility: Iwate Medical University Hospital; Urology

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: The Second Affiliated Hospital, Sun Yat-sen University

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

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

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Centre D'Oncologie de Gentilly; Oncology

title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.


ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

family: Burris

full_name: Howard A. Burris

given: Howard A.

family: Chan

full_name: Arlene Chan

given: Arlene

family: Bardia

full_name: Aditya Bardia

given: Aditya

family: Thaddeus Beck

full_name: J. Thaddeus Beck

given: J.

family: Sohn

full_name: Joohyuk Sohn

given: Joohyuk

family: Neven

full_name: Patrick Neven

given: Patrick

family: Tripathy

full_name: Debu Tripathy

given: Debu

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Chia

full_name: Stephen Chia

given: Stephen

family: Esteva

full_name: Francisco J. Esteva

given: Francisco J.

family: Hart

full_name: Lowell Hart

given: Lowell

family: Zarate

full_name: Juan Pablo Zarate

given: Juan Pablo

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Lorenc

full_name: Karen Rodriguez Lorenc

given: Karen Rodriguez

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

journal_name: British Journal of Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5. Erratum in: Ann Oncol. 2021 Oct;32(10):1307.

family: Slamon

full_name: D.J. Slamon

full_name: P. Neven

given: P.

full_name: S. Chia

given: S.

family: Jerusalem

full_name: G. Jerusalem

given: G.

family: De Laurentiis

full_name: M. De Laurentiis

given: M.

full_name: S. Im

family: Petrakova

full_name: K. Petrakova

given: K.

family: Valeria Bianchi

full_name: G. Valeria Bianchi

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

name: Department of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain

name: SOLTI Breast Cancer Research Group, Barcelona, Spain

name: Translational Genomics and Targeted Therapies in Solid Tumors, Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

name: Department of Medicine, University of Barcelona, Barcelona, Spain

name: Institute of Oncology (IOB) Quiron, Barcelona, Spain

name: Novartis Institutes for BioMedical Research, Cambridge, MA

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11.

name: From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) — all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen–European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University...

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

name: Department of Medical Oncology, Sarah Cannon Research Institute & Tennessee Oncology PLLC, Nashville, TN 37203, USA

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.

name: Dennis J. Slamon, University of California Los Angeles Medical Center, Santa Monica, CA; Patrick Neven, Multidisciplinary Breast Centre, Universitair Ziekenhuis, Leuven; Guy Jerusalem, Centre Hospitalier Universitaire de Liege and Liege University, Liège, Belgium; Stephen Chia, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Peter A. Fasching, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen; Arnd Nusch, Practice for Hematology and Internal...

title: Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Jordan
Malaysia
Australia
Belgium
Russian Federation
Denmark
France
Poland
Thailand
Norway
Canada
Korea, Republic of
Colombia
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Lebanon
Mexico
Czechia
Spain
Turkey

location_facility: Central Coast Medical Oncology Corporation SC

location_facility: Ironwood Cancer and Research Centers SC-2

location_facility: Virginia Mason Medical Center-Oncology SC

location_facility: University of New Mexico Cancer Center SC

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Penn State University Milton S Hershey Medical Center SC

location_facility: Florida Cancer Research Institute Dept of Oncology

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

location_facility: NYU Langone Medical Center CV Research center NYU Langone Medical Center

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC

title: A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

summary: This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.


ReferenceCitation: Kuemmel S, Tondini CA, Abraham J, Nowecki Z, Itrych B, Hitre E, Karaszewska B, Juárez-Ramiro A, Morales-Vásquez F, Pérez-García JM, Cardona-Huerta S, Monturus E, Sequi M, Restuccia E, Benyunes M, Martín M. Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study. Breast Cancer Res Treat. 2021 Jun;187(2):467-476. doi: 10.1007/s10549-021-06145-3. Epub 2021 Mar 21.

family: Kuemmel

full_name: Sherko Kuemmel

given: Sherko

family: Tondini

full_name: Carlo A. Tondini

given: Carlo A.

family: Abraham

full_name: Jacinta Abraham

given: Jacinta

family: Nowecki

full_name: Zbigniew Nowecki

given: Zbigniew

family: Itrych

full_name: Bartosz Itrych

given: Bartosz

family: Hitre

full_name: Erika Hitre

given: Erika

family: Karaszewska

full_name: Bogusława Karaszewska

given: Bogusława

family: Juárez-Ramiro

full_name: Alejandro Juárez-Ramiro

given: Alejandro

family: Morales-Vásquez

full_name: Flavia Morales-Vásquez

given: Flavia

family: Pérez-García

full_name: Jose Manuel Pérez-García

given: Jose Manuel

family: Cardona-Huerta

full_name: Servando Cardona-Huerta

given: Servando

family: Monturus

full_name: Estefania Monturus

given: Estefania

family: Sequi

full_name: Marco Sequi

given: Marco

family: Restuccia

full_name: Eleonora Restuccia

given: Eleonora

family: Benyunes

full_name: Mark Benyunes

given: Mark

family: Martín

full_name: Miguel Martín

given: Miguel

journal_name: Breast Cancer Research and Treatment

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Mexico
Spain
France
Bulgaria
Poland
Hungary
Belgium
Portugal
Germany
United Kingdom
Canada

acronym: MetaPHer

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

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

location_facility: Hopital Saint Joseph; Service de Rhumatologie

location_facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD

location_facility: Superare Centro de Infusion S.A. de C.V.

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Onkologische Schwerpunktpraxis Dr. Joerg Schilling

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Pole Sante Republique; Pharmacie Oncologique

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

location_facility: Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Ospedale Santo Stefano, Azienda USL Centro Prato

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie

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

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie

location_facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

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

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

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

study_completion_date_type: Actual

title: A MULTICENTER, OPEN-LABEL, SINGLE-ARM SAFETY STUDY OF HERCEPTIN® SC IN COMBINATION WITH PERJETA® AND DOCETAXEL IN TREATMENT OF PATIENTS WITH HER2−POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT)

summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

status_simplified: Completed


title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

summary: The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

currency_apc_doaj: GBP

journal_name: Respiratory Research

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Dundee - Discovery Research Portal

repositories_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.

family: Bateman

full_name: E.D. Bateman

family: Tashkin

full_name: D. Tashkin

given: D.

family: Siafakas

full_name: N. Siafakas

given: N.

family: Dahl

full_name: R. Dahl

given: R.

family: Towse

full_name: L. Towse

given: L.

family: Massey

full_name: D. Massey

family: Pavia

full_name: D. Pavia

family: Zhong

full_name: N.S. Zhong

title: A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients

location_country:
Finland
Malaysia
Greece
Australia
Denmark
Taiwan
India
France
Lithuania
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: 205.372.31009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11016 London Road Diagnostic Clinic and Medical Centre

location_facility: 205.372.86008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01055 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11005 Professional Corp. Respirology

location_facility: 205.372.35804 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01022 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01031 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52016 Hospital General de Mexicali

location_facility: 205.372.45006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.42102 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01063 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88608 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01064 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.

location_facility: 205.372.31002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44028 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01068 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01046 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01044 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11007 Heritage Medical Research Building

location_facility: 205.372.65001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01039 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.42103 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01037 Boehringer Ingelheim Investigational Site

location_facility: 205.372.45004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88606 National Cheng Kung University Hospital

location_facility: 205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

location_facility: 205.372.90010 Selcuk Universitesi Tip Fakultesi

location_facility: 205.372.49003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01035 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

location_facility: 205.372.01024 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.37003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52014 Hospital Angeles de las Lomas

location_facility: 205.372.27002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11009 White Hills Medical Clinic

location_facility: 205.372.44019 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01062 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01067 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88605 Chang Gung Memorial Hosp-Linkou

location_facility: 205.372.61002 Woolcock Institute of Medical Research

location_facility: 205.372.88602 Taipei Veterans General Hospital

location_facility: 205.372.44011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11020 Wetaskiwin Lung Laboratory

location_facility: 205.372.91001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01040 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D

location_facility: 205.372.49007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35803 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55012 Universidade Federal de Santa Catarina

location_facility: 205.372.91005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01036 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44022 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.45002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44026 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.34005 Hospital San Pedro de Alcántara

location_facility: 205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari

location_facility: 205.372.52001 Hospital General del Estado de Sonora

location_facility: 205.372.39008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44021 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88604 Tri-Service General Hospital

location_facility: 205.372.36006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52018 Hospital Universitario de Chihuahua

location_facility: 205.372.47001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01028 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11012 West Lincoln Memorial Hospital

location_facility: 205.372.86002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30019 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11018 Pacific Lung Health Centre

location_facility: 205.372.31005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52010 Hospital General Agustin O´Haran

location_facility: 205.372.86010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01038 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01053 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.65005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88609 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)

location_facility: 205.372.52002 Unidad de Investigación clínica en Medicina

location_facility: 205.372.55009 Hospital das Clínicas de Goiânia

location_facility: 205.372.01056 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44027 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44023 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01021 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49016 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61003 Sir Charles Gairdner Hospital

location_facility: 205.372.01045 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01048 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90008 Erciyes Universitesi Tip Fakultesi

location_facility: 205.372.44013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11003 London Road Diagnostic Clinic and Medical Centre

location_facility: 205.372.44012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01026 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi

location_facility: 205.372.44020 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01066 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91008 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia


title: A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

acronym: RECORD

summary: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

ReferenceType: background

ReferenceCitation: Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. Epub 2005 Jul 16.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. Epub 2007 Jun 5.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.

ReferenceCitation: Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.

ReferenceCitation: Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015 Jun;52(3):539-46. doi: 10.1007/s00592-014-0691-y. Epub 2014 Dec 19.

family: Jones

full_name: Nigel P. Jones

given: Nigel P.

family: Curtis

full_name: Paula S. Curtis

given: Paula S.

family: Home

full_name: Philip D. Home

given: Philip D.

journal_name: Acta Diabetologica

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.

family: MacDonald

full_name: M. R. MacDonald

given: M. R.

family: Petrie

full_name: M. C. Petrie

given: M. C.

full_name: P. D. Home

given: P. D.

family: Komajda

full_name: M. Komajda

given: M.

full_name: N. P. Jones

given: N. P.

family: Beck-Nielsen

full_name: H. Beck-Nielsen

given: H.

family: Gomis

full_name: R. Gomis

family: Hanefeld

full_name: M. Hanefeld

family: Pocock

full_name: S. J. Pocock

given: S. J.

full_name: P. S. Curtis

given: P. S.

family: McMurray

full_name: J. J. V. McMurray

given: J. J. V.

journal_name: Diabetes Care

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

repository_institution: Australian Catholic University - Research Bank

repository_institution: Newcastle Univesity - Newcastle University ePrints

title: Incidence and Prevalence of Unrecognized Myocardial Infarction in People With Diabetes: A substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study

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:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Sweden
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
New Zealand
Spain
Estonia
Latvia