Clinical trial NCT02964949: Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes
Official title: Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Nonvalvular Atrial Fibrillation
High Creatinine Clearance
Developmental Phase III
Anticoagulant Naïve
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2016-11-16
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Primary outcomes:
measure: Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)
timeFrame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
measure: Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)
timeFrame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
measure: Pharmacodynamics: Mean exposure using validated assays
timeFrame: 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)
measure: Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay
timeFrame: 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:
measure: Efficacy: Number of participants with composite event 1
timeFrame: within 3 years
measure: Efficacy: Number of participants with composite event 2
timeFrame: within 3 years
measure: Safety: Number of participants with major bleeding (including intracranial)
timeFrame: within 3 years
measure: Safety: Number of participants with clinically relevant bleeding
timeFrame: within 3 years
measure: Safety: Number of participants with any bleeding
timeFrame: within 3 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O L V Ziekenhuis
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Bruxelles
country: Belgium
facility: C H U Brugmann - Site Victor Horta
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Heusden-Zolder
country: Belgium
facility: St-Franciskus Ziekenhuis
city: Leuven
country: Belgium
facility: Universitairsitaire Ziekenhuizen Leuven
city: Liege
country: Belgium
facility: C H R de la Citadelle
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Turnhout
country: Belgium
facility: AZ Turnhout - Campus Sint-Elisabeth
city: Dimitrovgrad
country: Bulgaria
facility: MHAT 'Sveta Ekaterina' EOOD
city: Gabrovo
country: Bulgaria
facility: MHAT Dr Tota Venkova AD
city: Haskovo
country: Bulgaria
facility: Medical Center Haskovo EOOD
city: Haskovo
country: Bulgaria
facility: MHAT-Haskovo AD
city: Pazardzhik
country: Bulgaria
facility: MHAT - Pazardzhik AD
city: Pleven
country: Bulgaria
facility: MHAT Sv Pantaleymon - Pleven OOD
city: Pleven
country: Bulgaria
facility: SHATC Pleven EAD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr Georgi Stranski' EAD
city: Plovdiv
country: Bulgaria
facility: UMHAT Sv Georgi EAD
city: Plovdiv
country: Bulgaria
facility: MHAT-Plovdiv AD
city: Sofia
country: Bulgaria
facility: Second MHAT - Sofia AD
city: Sofia
country: Bulgaria
facility: Fifth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: NMTH Tsar Boris III
city: Sofia
country: Bulgaria
facility: MHAT - National Heart Hospital EAD
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL' EAD
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Sveta Anna' AD
city: Varna
country: Bulgaria
facility: SHATC Cardiolife OOD
city: Dubrovnik
country: Croatia
facility: General Hospital Dubrovnik
city: Koprivnica
country: Croatia
facility: General Hospital Dr Tomislav Bardek
city: Krapinske Toplice
country: Croatia
facility: Special Hospital for medical rehabilitation
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Slavonski Brod
country: Croatia
facility: General Hospital Dr Josip Bencevic
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: University Hospital center Zagreb (2108)
city: Zagreb
country: Croatia
facility: University Hospital center Zagreb (2110)
city: Benesov
country: Czechia
facility: Innera s r o
city: Bilovec
country: Czechia
facility: Poliklinika Humanitas
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Broumov
country: Czechia
facility: Edumed s.r.o
city: Havlickuv Brod
country: Czechia
facility: Nemocnice Havlickuv Brod, p.o.
city: Hradec Kralove
country: Czechia
facility: Kardio-Pisova, s.r.o.
city: Kolin
country: Czechia
facility: Oblastni nemocnice Kolin, a.s.
city: Kromeriz
country: Czechia
facility: Centrum pro choroby srdce a cev
city: Kromeriz
country: Czechia
facility: Kromerizska nemocnice, a.s.
city: Marianske Lazne
country: Czechia
facility: InterKardioML s r o
city: Pardubice
country: Czechia
facility: PV - kardiologie s.r.o.
city: Prague
country: Czechia
facility: Corintez s.r.o
city: Praha 10
country: Czechia
facility: Ordince pro choroby srdce a cev
city: Praha 1
country: Czechia
facility: AVICENA -KARDIOLOGIE, INTERNA s.r.o.
city: Praha 1
country: Czechia
facility: Nemocnice na Frantisku
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Kardio-Pisova sro
city: Pribram 8
country: Czechia
facility: Poliklinika RAVAK
city: Příbram
country: Czechia
facility: Oblastni nemocnice Pribram, a.s.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Trutnov
country: Czechia
facility: Poliklinika Masarykuv Dum, s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Clinical Trials Services s.r.o
city: Zlin
country: Czechia
facility: Krajska nemocnice T Bati a s
city: Copenhagen S
country: Denmark
facility: Amager Hospital
city: Copenhagen
country: Denmark
facility: Bispebjeg og Fredeiksberg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Nykøbing Falster
country: Denmark
facility: Nykøbing F Sygehus
city: Slagelse
country: Denmark
facility: Slagelse Sygehus
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Dr Arvo Rosenthal LLC
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Baja
country: Hungary
facility: Principal SMO Kft
city: Bekescsaba
country: Hungary
facility: Belgyogyaszati es Kardiologiai Maganrendelo
city: Berettyoujfalu
country: Hungary
facility: Grof Tisza Istvan Korhaz
city: Budapest
country: Hungary
facility: Budapesti Szent Ferenc Korhaz
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont (4002)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont (4025)
city: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Hodmezovasarhely
country: Hungary
facility: Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
city: Kalocsa
country: Hungary
facility: Studium Egeszseghaz Kft
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
city: Komarom
country: Hungary
facility: Selye Janos Korhaz
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Korhaz
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr Bugyi Istvan Korhaz
city: Veszprem
country: Hungary
facility: Jeruzsalemhegyi Egeszseghaz
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Jekabpils
country: Latvia
facility: Dr Iveta Neniske GP Practice
city: Jelgava
country: Latvia
facility: Jelgava Outpatient Clinic
city: Kuldiga
country: Latvia
facility: Dr R Eglite's Private practice
city: Liepaja
country: Latvia
facility: Inese Cebere GP practice
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Clinic of GP A Lasmanis ALMA
city: Riga
country: Latvia
facility: GK Neiroklinika
city: Riga
country: Latvia
facility: Health Centre 4
city: Valmiera
country: Latvia
facility: Dr D Harasimjuka GP Practice
city: Ventspils
country: Latvia
facility: Regional Hospital of Ziemelkurzeme
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital Public Institution
city: Kaunas
country: Lithuania
facility: Saules Seimos Medicinos Centras JSC
city: Kaunas
country: Lithuania
facility: Elite Medicale JSC
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Klaipeda
country: Lithuania
facility: Cardiology and Rehabilitation Clinic JSC
city: Klaipeda
country: Lithuania
facility: Klaipeda Republican Hospital Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic Public Institution
city: Bialystok
country: Poland
facility: CERMED
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Elblag
country: Poland
facility: KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
city: Gdansk
country: Poland
facility: Synexus Polska SCM Sp z o o Gdansku
city: Gdynia
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman
city: Gdynia
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Gdyni
city: Katowice
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Katowicach
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek ALL-MED
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med
city: Libiaz
country: Poland
facility: Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak
city: Lodz
country: Poland
facility: Polimedica Centrum Badań Profilaktyki I Leczenia
city: Lodz
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
city: Lomza
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Oswiecim
country: Poland
facility: Medicome Sp z o o
city: Pulawy
country: Poland
facility: SPZOZ w Pulawach Szpital Specjalistyczny
city: Ruda Slaska
country: Poland
facility: Janusz Spyra Specjalistyczna Praktyka Lekarska
city: Rzeszow
country: Poland
facility: Centrum Medyczne Sabamed - Rzeszów
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog
city: Szczecin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez
city: Warszawa
country: Poland
facility: Synexus Polska Sp z o o Oddział w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp z o o Oddział we Wroclawiu
city: Zamosc
country: Poland
facility: KO-MED Centra Kliniczne Zamosc
city: Barnaul
country: Russian Federation
facility: TSHI Altay Territorial Cardiologocal dispensary
city: Chelyabinsk
country: Russian Federation
facility: City Hospital 1
city: Kemerovo
country: Russian Federation
facility: FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
city: Kemerovo
country: Russian Federation
facility: Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways
city: Kemerovo
country: Russian Federation
facility: FSHI "MSU of MoIA of RF of Kemerovo Region"
city: Moscow
country: Russian Federation
facility: SBIH of Moscow City Clinical Hospital 17
city: Moscow
country: Russian Federation
facility: FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF
city: Novosibirsk
country: Russian Federation
facility: SBIH of Novosibirsk Region Clinical Emergency Hospital 2
city: Omsk
country: Russian Federation
facility: Ultramed
city: Orenburg
country: Russian Federation
facility: SBEI HPE Orenburg State Medical University of the MoH of the RF
city: Pushkin
country: Russian Federation
facility: SPb SBIH City Hospital 38 n a N A Semashko
city: Ryazan'
country: Russian Federation
facility: SBI of Ryazan region Regional Clinical Cardiological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: FSBIH SPb Clinical Hospital of RAS
city: Saint Petersburg
country: Russian Federation
facility: FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine
city: Saint Petersburg
country: Russian Federation
facility: StP SHI Clinical hospital of St Luka
city: Saint Petersburg
country: Russian Federation
facility: SBI of HE Northwestern SMU n a I I Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: SHI "Center of Occupational Pathology"
city: Saint Petersburg
country: Russian Federation
facility: LLC "Institute of Medical Investigations"
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical Institute on Krestovsky
city: Saint Petersburg
country: Russian Federation
facility: North-West Federal Medical Research Center n a V A Almazov
city: Saint Petersburg
country: Russian Federation
facility: SPb SBIH City Hospital 15
city: Saint Petersburg
country: Russian Federation
facility: FSBI Saint-Petersburg Multidisciplinary Centre
city: Saint Petersburg
country: Russian Federation
facility: SPB SHI Pokrovskaya City Hospital
city: Smolensk
country: Russian Federation
facility: SBEI HPE Smolensk State Medical University of the MoH of the RF
city: Tomsk
country: Russian Federation
facility: FSBI Research Institute for Cardiology of Siberian Branch RAMS
city: Yaroslavl'
country: Russian Federation
facility: SBIH of Yaroslavl region Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Dr Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niska Banja
country: Serbia
facility: Niska Banja
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases of Vojvodina
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky ustav srdcovych a cievnych chorob a s
city: Bardejov
country: Slovakia
facility: Alian s r o
city: Bratislava
country: Slovakia
facility: Cardioconsult s r o
city: Bratislava
country: Slovakia
facility: DIAMETABOL s r o
city: Bratislava
country: Slovakia
facility: Veria s r o
city: Kosice
country: Slovakia
facility: Medicalgroup s r o
city: Lucenec
country: Slovakia
facility: KARDIO 1 s r o
city: Povazska Bystrica
country: Slovakia
facility: Kardiologicka ambulancia Dr Kolikova
city: Presov
country: Slovakia
facility: Medispol s r o
city: Svidnik
country: Slovakia
facility: Interna SK s r o
city: Zilina
country: Slovakia
facility: MEDIVASA s r o
city: Almeria
country: Spain
facility: Hospital Virgen del Mar
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Quiron Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Deu
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Talavera de la Reina
country: Spain
facility: Hospital Nuestra Señora del Prado
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Cardiological Center
city: Cherkasy
country: Ukraine
facility: CI Cherkasy RH of Cherkasy Regional Council
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Cardiology Dispensary
city: Kharkiv
country: Ukraine
facility: GI L T Malaya Therapy National Institute of the NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
city: Kharkiv
country: Ukraine
facility: SI Institute of General & Emergency Surgery of NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: SMPI Central Clinical Hospital of Ukrzaliznytsia
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU
city: Kyiv
country: Ukraine
facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital 1
city: Kyiv
country: Ukraine
facility: Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC
city: Kyiv
country: Ukraine
facility: SI Heart Institute of the MoH of Ukraine
city: Kyiv
country: Ukraine
facility: SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)
city: Kyiv
country: Ukraine
facility: SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)
city: Luts'k
country: Ukraine
facility: CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
city: Lviv
country: Ukraine
facility: Regional State Clinical Treatment-Diagnostic Cardiological Centre
city: Odesa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery
city: Odesa
country: Ukraine
facility: Multifield Medical Center of Odesa NMU (University Clinic 1)
city: Poltava
country: Ukraine
facility: First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy
city: Uzhgorod
country: Ukraine
facility: Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU
city: Vinnytsya
country: Ukraine
facility: M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1
city: Zaporizhzhya
country: Ukraine
facility: CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU
city: Zhytomyr
country: Ukraine
facility: O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC
city: Zhytomyr
country: Ukraine
facility: CI Central City Hospital 2 of Zhytomyr
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: