NCT03666650

Brief Summary

Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

September 8, 2018

Last Update Submit

September 13, 2019

Conditions

Blood Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

  • correlation of edoxaban peak plasma concentrations and viscoelastic analysis

    viscoelastic test values and blood coagulation laboratory parameters

    1 day

Study Arms (1)

Rotem

OTHER
Drug: Edoxaban 60 MG

Interventions

Edoxaban 60 MGDRUG

Viscoelastic analysis and standard laboratory tests after edoxaban ingestion

Rotem

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

  • intolerance of the study drug history of bleeding disorder or similar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Southwest Finland, 20500, Finland

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Study Principal Investigator, Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 12, 2018

Study Start

November 26, 2018

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)