Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Last updated: February 8, 2019
Sponsor: Daiichi Sankyo, Inc.
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT02964949
DU176b-C-E314
2016-001795-30
  • Ages > 18
  • All Genders

Study 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

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 andmedications

  • Voluntarily consents to participate and provides written informed consent prior to anyprotocol-specific procedures

Exclusion

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, ordrugs (including nicotine and alcohol) outside protocol-specified parameters

  • Has signs, symptoms or history of any condition that, per protocol or in the opinionof 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 throughpregnancy or breast-feeding)

  3. the analysis of results

Study Design

Total Participants: 607
Study Start date:
January 24, 2017
Estimated Completion Date:
October 09, 2018

Connect with a study center

  • O L V Ziekenhuis

    Aalst, 9300
    Belgium

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  • ZNA Middelheim

    Antwerpen, 2260
    Belgium

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    Brugge, 8000
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  • C H U Brugmann - Site Victor Horta

    Bruxelles, 1020
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  • Jessa Ziekenhuis - Campus Virga Jesse

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    Leuven, 3000
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  • C H R de la Citadelle

    Liege, 4000
    Belgium

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  • AZ Sint-Maarten

    Mechelen, 2800
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  • AZ Turnhout - Campus Sint-Elisabeth

    Turnhout, 2300
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    Site Not Available

  • MHAT 'Sveta Ekaterina' EOOD

    Dimitrovgrad, 6400
    Bulgaria

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  • MHAT Dr Tota Venkova AD

    Gabrovo, 5300
    Bulgaria

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  • MHAT-Haskovo AD

    Haskovo, 6300
    Bulgaria

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  • Medical Center Haskovo EOOD

    Haskovo, 6300
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  • MHAT - Pazardzhik AD

    Pazardzhik, 4400
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    Pleven, 5800
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  • SHATC Pleven EAD

    Pleven, 5800
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    Pleven, 5800
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    Ukraine

    Site Not Available

  • Ivano-Frankivsk Regional Clinical Cardiology Dispensary

    Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU

    Kharkiv, 61176
    Ukraine

    Site Not Available

  • GI L T Malaya Therapy National Institute of the NAMS of Ukraine

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • SI Institute of General & Emergency Surgery of NAMS of Ukraine

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • SMPI Central Clinical Hospital of Ukrzaliznytsia

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

    Kyiv, 01103
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital 1

    Kyiv, 2091
    Ukraine

    Site Not Available

  • Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC

    Kyiv, 2091
    Ukraine

    Site Not Available

  • SI Heart Institute of the MoH of Ukraine

    Kyiv, 2660
    Ukraine

    Site Not Available

  • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)

    Kyiv, 3680
    Ukraine

    Site Not Available

  • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)

    Kyiv, 3680
    Ukraine

    Site Not Available

  • Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC

    Kyyiv, 2091
    Ukraine

    Site Not Available

  • CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

    Luts'k, 43024
    Ukraine

    Site Not Available

  • Regional State Clinical Treatment-Diagnostic Cardiological Centre

    Lviv, 79015
    Ukraine

    Site Not Available

  • CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery

    Odesa, 65025
    Ukraine

    Site Not Available

  • Multifield Medical Center of Odesa NMU (University Clinic 1)

    Odesa, 65026
    Ukraine

    Site Not Available

  • First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy

    Poltava, 36038
    Ukraine

    Site Not Available

  • Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1

    Vinnytsya, 21018
    Ukraine

    Site Not Available

  • CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU

    Zaporizhzhya, 69001
    Ukraine

    Site Not Available

  • CI Central City Hospital 2 of Zhytomyr

    Zhytomyr, 10004
    Ukraine

    Site Not Available

  • O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC

    Zhytomyr, 10003
    Ukraine

    Site Not Available

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