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

NCT02964949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2019-02-12

No results posted yet for this 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).

Conditions

Interventions

DRUG

Edoxaban

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-10-09
Completion
2018-10-09

Countries

  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964949 on ClinicalTrials.gov