Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes
Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance
2 other identifiers
interventional
607
14 countries
223
Brief Summary
Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Jan 2017
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedStudy Start
First participant enrolled
January 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2018
CompletedFebruary 12, 2019
December 1, 2018
1.7 years
November 14, 2016
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)
In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination
After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)
Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose
After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure using validated assays
Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma. Categories: Edoxaban and its metabolite (D21-2393)
Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay
Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393
Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Secondary Outcomes (5)
Efficacy: Number of participants with composite event 1
within 3 years
Efficacy: Number of participants with composite event 2
within 3 years
Safety: Number of participants with major bleeding (including intracranial)
within 3 years
Safety: Number of participants with clinically relevant bleeding
within 3 years
Safety: Number of participants with any bleeding
within 3 years
Study Arms (2)
Edoxaban 75 mg
EXPERIMENTALEdoxaban 60 mg + edoxaban 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.
Edoxaban 60 mg
ACTIVE COMPARATOREdoxaban 60 mg + placebo 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.
Interventions
Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.
Eligibility Criteria
You may qualify if:
- Meets protocol-specified criteria for qualification
- Is able to follow the protocol specified contraception methods
- Is willing and able to comply with any restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
You may not qualify if:
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Quintiles, Inc.collaborator
Study Sites (233)
O L V Ziekenhuis
Aalst, 9300, Belgium
ZNA Middelheim
Antwerp, 2260, Belgium
AZ Sint-Jan Brugge
Bruges, 8000, Belgium
C H U Brugmann - Site Victor Horta
Brussels, 1020, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
St-Franciskus Ziekenhuis
Heusden-Zolder, 3550, Belgium
Universitairsitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
C H R de la Citadelle
Liège, 4000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
AZ Turnhout - Campus Sint-Elisabeth
Turnhout, 2300, Belgium
MHAT 'Sveta Ekaterina' EOOD
Dimitrovgrad, 6400, Bulgaria
MHAT Dr Tota Venkova AD
Gabrovo, 5300, Bulgaria
Medical Center Haskovo EOOD
Haskovo, 6300, Bulgaria
MHAT-Haskovo AD
Haskovo, 6300, Bulgaria
MHAT - Pazardzhik AD
Pazardzhik, 4400, Bulgaria
MHAT Sv Pantaleymon - Pleven OOD
Pleven, 5800, Bulgaria
SHATC Pleven EAD
Pleven, 5800, Bulgaria
UMHAT 'Dr Georgi Stranski' EAD
Pleven, 5800, Bulgaria
UMHAT Sv Georgi EAD
Plovdiv, 4000, Bulgaria
MHAT-Plovdiv AD
Plovdiv, 4002, Bulgaria
Second MHAT - Sofia AD
Sofia, 1202, Bulgaria
Fifth MHAT - Sofia EAD
Sofia, 1233, Bulgaria
NMTH Tsar Boris III
Sofia, 1233, Bulgaria
MHAT - National Heart Hospital EAD
Sofia, 1309, Bulgaria
UMHAT Alexandrovska EAD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL' EAD
Sofia, 1527, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
UMHAT 'Sveta Anna' AD
Sofia, 1750, Bulgaria
SHATC Cardiolife OOD
Varna, 9000, Bulgaria
General Hospital Dubrovnik
Dubrovnik, 20000, Croatia
General Hospital Dr Tomislav Bardek
Koprivnica, 48000, Croatia
Special Hospital for medical rehabilitation
Krapinske Toplice, 49217, Croatia
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
General Hospital Dr Josip Bencevic
Slavonski Brod, 35000, Croatia
General Hospital Varazdin
Varaždin, 42000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Clinical Hospital Sveti Duh
Zagreb, 10000, Croatia
University Hospital center Zagreb (2108)
Zagreb, 10000, Croatia
University Hospital center Zagreb (2110)
Zagreb, 10000, Croatia
Innera s r o
Benešov, 256 01, Czechia
Poliklinika Humanitas
Bílovec, 743. 01, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Edumed s.r.o
Broumov, 550 01, Czechia
Nemocnice Havlickuv Brod, p.o.
Havlíčkův Brod, 580 22, Czechia
Kardio-Pisova, s.r.o.
Hradec Králové, 500 02, Czechia
Oblastni nemocnice Kolin, a.s.
Kolín, 280 00, Czechia
Centrum pro choroby srdce a cev
Kroměříž, 767 01, Czechia
Kromerizska nemocnice, a.s.
Kroměříž, 767 01, Czechia
InterKardioML s r o
Mariánské Lázně, 353 01, Czechia
PV - kardiologie s.r.o.
Pardubice, 530 02, Czechia
Ordince pro choroby srdce a cev
Prague, 101 00, Czechia
AVICENA -KARDIOLOGIE, INTERNA s.r.o.
Prague, 110 00, Czechia
Nemocnice na Frantisku
Prague, 110 00, Czechia
Kardio-Pisova sro
Prague, 148 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Corintez s.r.o
Prague, 158 00, Czechia
Poliklinika RAVAK
Příbram, 261 01, Czechia
Oblastni nemocnice Pribram, a.s.
Příbram, 261 95, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Poliklinika Masarykuv Dum, s.r.o.
Trutnov, 541 01, Czechia
Clinical Trials Services s.r.o
Uherské Hradiště, 686 01, Czechia
Krajska nemocnice T Bati a s
Zlín, 760 01, Czechia
Bispebjeg og Fredeiksberg Hospital
Copenhagen, 2400, Denmark
Amager Hospital
Copenhagen S, 2300, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Holbæk Sygehus
Holbæk, 4300, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Rigshospitalet
København Ø, 2100, Denmark
Nykøbing F Sygehus
Nykøbing Falster, 4800, Denmark
Slagelse Sygehus
Slagelse, 4200, Denmark
Regionshospitalet Viborg
Viborg, 8800, Denmark
East Tallinn Central Hospital
Tallinn, 101389, Estonia
Dr Arvo Rosenthal LLC
Tallinn, 13419, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Principal SMO Kft
Baja, 6500, Hungary
Grof Tisza Istvan Korhaz
Berettyóújfalu, 4101, Hungary
Belgyogyaszati es Kardiologiai Maganrendelo
Békéscsaba, 5600, Hungary
Budapesti Szent Ferenc Korhaz
Budapest, 1021, Hungary
Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
Szent Margit Korhaz
Budapest, 1032, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106, Hungary
Semmelweis Egyetem
Budapest, 1122, Hungary
Semmelweis Egyetem
Budapest, 1125, Hungary
Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
Budapest, 1135, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Kozpont (4002)
Debrecen, 4032, Hungary
Debreceni Egyetem Klinikai Kozpont (4025)
Debrecen, 4032, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
Hódmezővásárhely, 6800, Hungary
Studium Egeszseghaz Kft
Kalocsa, 6300, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000, Hungary
Selye Janos Korhaz
Komárom, 2921, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, 8800, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Csongrad Megyei Dr Bugyi Istvan Korhaz
Szentes, 6600, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Jeruzsalemhegyi Egeszseghaz
Veszprém, 8200, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Daugavpils Regional Hospital
Daugavpils, LV-5417, Latvia
Jelgava Outpatient Clinic
Jelgava, LV-3001, Latvia
Dr Iveta Neniske GP Practice
Jēkabpils, LV-5201, Latvia
Dr R Eglite's Private practice
Kuldīga, LV-3301, Latvia
Inese Cebere GP practice
Liepāja, LV-3401, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV-1002, Latvia
Clinic of GP A Lasmanis ALMA
Riga, LV-1010, Latvia
GK Neiroklinika
Riga, LV-1011, Latvia
Health Centre 4
Riga, LV-1012, Latvia
Dr D Harasimjuka GP Practice
Valmiera, LV-4201, Latvia
Regional Hospital of Ziemelkurzeme
Ventspils, LV-3601, Latvia
Kaunas Clinical Hospital Public Institution
Kaunas, 47144, Lithuania
Saules Seimos Medicinos Centras JSC
Kaunas, 49449, Lithuania
Elite Medicale JSC
Kaunas, 50177, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103)
Kaunas, LT-50009, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Cardiology and Rehabilitation Clinic JSC
Klaipėda, 91131, Lithuania
Klaipeda Republican Hospital Public Institution
Klaipėda, 92231, Lithuania
Vilnius University Hospital Santariskiu Clinic Public Institution
Vilnius, LT-08661, Lithuania
CERMED
Bialystok, 15-270, Poland
KLIMED Marek Klimkiewicz
Bialystok, 15-765, Poland
KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
Elblag, 82-300, Poland
Synexus Polska SCM Sp z o o Gdansku
Gdansk, 80-382, Poland
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman
Gdynia, 81-157, Poland
Synexus Polska Sp z o o Oddzial w Gdyni
Gdynia, 81-384, Poland
Synexus Polska Sp z o o Oddzial w Katowicach
Katowice, 40-040, Poland
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
Krakow, 31-023, Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, 95-054, Poland
Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak
Libiąż, 32-590, Poland
Polimedica Centrum Badań Profilaktyki I Leczenia
Lodz, 90-302, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, 93-153, Poland
Medicome Sp z o o
Oświęcim, 32-600, Poland
SPZOZ w Pulawach Szpital Specjalistyczny
Puławy, 24-100, Poland
Janusz Spyra Specjalistyczna Praktyka Lekarska
Ruda Śląska, 41-709, Poland
Centrum Medyczne Sabamed - Rzeszów
Rzeszów, 35-006, Poland
Centrum Medyczne Medyk
Rzeszów, 35-055, Poland
NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog
Sopot, 81-717, Poland
Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez
Szczecin, 70-506, Poland
Synexus Polska Sp z o o Oddział w Warszawie
Warsaw, 01-192, Poland
Synexus Polska Sp z o o Oddział we Wroclawiu
Wroclaw, 50-088, Poland
KO-MED Centra Kliniczne Zamosc
Zamość, 22-400, Poland
KLIMED Marek Klimkiewicz
Łomża, 18-404, Poland
TSHI Altay Territorial Cardiologocal dispensary
Barnaul, 656055, Russia
City Hospital 1
Chelyabinsk, 454048, Russia
FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
Kemerovo, 650002, Russia
Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways
Kemerovo, 650055, Russia
FSHI "MSU of MoIA of RF of Kemerovo Region"
Kemerovo, 650099, Russia
SBIH of Moscow City Clinical Hospital 17
Moscow, 119620, Russia
FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF
Moscow, 121522, Russia
SBIH of Novosibirsk Region Clinical Emergency Hospital 2
Novosibirsk, 630008, Russia
Ultramed
Omsk, 644024, Russia
SBEI HPE Orenburg State Medical University of the MoH of the RF
Orenburg, 460000, Russia
SPb SBIH City Hospital 38 n a N A Semashko
Pushkin, 196601, Russia
SBI of Ryazan region Regional Clinical Cardiological Dispensary
Ryazan, 390026, Russia
FSBIH SPb Clinical Hospital of RAS
Saint Petersburg, 194017, Russia
FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine
Saint Petersburg, 194044, Russia
StP SHI Clinical hospital of St Luka
Saint Petersburg, 194044, Russia
SBI of HE Northwestern SMU n a I I Mechnikov
Saint Petersburg, 195067, Russia
SHI "Center of Occupational Pathology"
Saint Petersburg, 195271, Russia
LLC "Institute of Medical Investigations"
Saint Petersburg, 196084, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
LLC Medical Institute on Krestovsky
Saint Petersburg, 197110, Russia
North-West Federal Medical Research Center n a V A Almazov
Saint Petersburg, 197341, Russia
SPb SBIH City Hospital 15
Saint Petersburg, 198205, Russia
FSBI Saint-Petersburg Multidisciplinary Centre
Saint Petersburg, 199004, Russia
SPB SHI Pokrovskaya City Hospital
Saint Petersburg, 199106, Russia
SBEI HPE Smolensk State Medical University of the MoH of the RF
Smolensk, 214019, Russia
FSBI Research Institute for Cardiology of Siberian Branch RAMS
Tomsk, 634012, Russia
SBIH of Yaroslavl region Regional Clinical Hospital
Yaroslavl, 150062, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, 11040, Serbia
Dedinje Cardiovascular Institute
Belgrade, 11040, Serbia
Clinical Center Bezanijska kosa
Belgrade, 11080, Serbia
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, 21204, Serbia
Clinical Center Kragujevac
Kragujevac, 11000, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Niska Banja
Niška Banja, 18205, Serbia
Stredoslovensky ustav srdcovych a cievnych chorob a s
Banská Bystrica, 97401, Slovakia
Alian s r o
Bardejov, 8501, Slovakia
Cardioconsult s r o
Bratislava, 81104, Slovakia
DIAMETABOL s r o
Bratislava, 82106, Slovakia
Veria s r o
Bratislava, 85101, Slovakia
Medicalgroup s r o
Košice, 4001, Slovakia
KARDIO 1 s r o
Lučenec, 984 39, Slovakia
Kardiologicka ambulancia Dr Kolikova
Považská Bystrica, 1701, Slovakia
Medispol s r o
Prešov, 8001, Slovakia
Interna SK s r o
Svidník, 8901, Slovakia
MEDIVASA s r o
Žilina, 1001, Slovakia
Hospital Virgen del Mar
Almería, 4120, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital Quiron Barcelona
Barcelona, 8023, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, 8830, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Nuestra Señora del Prado
Talavera de la Reina, 45600, Spain
Cherkasy Regional Cardiological Center
Cherkasy, 18009, Ukraine
CI Cherkasy RH of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76018, Ukraine
Ivano-Frankivsk Regional Clinical Cardiology Dispensary
Ivano-Frankivsk, 76018, Ukraine
GI L T Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039, Ukraine
Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
Kharkiv, 61103, Ukraine
SI Institute of General & Emergency Surgery of NAMS of Ukraine
Kharkiv, 61103, Ukraine
SMPI Central Clinical Hospital of Ukrzaliznytsia
Kharkiv, 61103, Ukraine
CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU
Kharkiv, 61176, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, 01103, Ukraine
Kyiv City Clinical Hospital 1
Kyiv, 2091, Ukraine
Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC
Kyiv, 2091, Ukraine
SI Heart Institute of the MoH of Ukraine
Kyiv, 2660, Ukraine
SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)
Kyiv, 3680, Ukraine
SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)
Kyiv, 3680, Ukraine
CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
Lutsk, 43024, Ukraine
Regional State Clinical Treatment-Diagnostic Cardiological Centre
Lviv, 79015, Ukraine
CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery
Odesa, 65025, Ukraine
Multifield Medical Center of Odesa NMU (University Clinic 1)
Odesa, 65026, Ukraine
First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy
Poltava, 36038, Ukraine
Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU
Uzhhorod, 88000, Ukraine
M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1
Vinnytsia, 21018, Ukraine
CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU
Zaporizhzhya, 69001, Ukraine
O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC
Zhytomyr, 10003, Ukraine
CI Central City Hospital 2 of Zhytomyr
Zhytomyr, 10004, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2016
First Posted
November 16, 2016
Study Start
January 24, 2017
Primary Completion
October 9, 2018
Study Completion
October 9, 2018
Last Updated
February 12, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/