NCT01028950

Brief Summary

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 16, 2010

Status Verified

June 1, 2010

Enrollment Period

11 months

First QC Date

December 7, 2009

Last Update Submit

June 14, 2010

Conditions

Venous Thromboembolism

Keywords

YM150BleedingVTEFXa inhibitorDeep Vein ThrombosisVenous thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Composite assessment of VTE events and all cause death

    Until day 28

Secondary Outcomes (1)

  • Incidence of bleeding events

    Until day 28

Study Arms (1)

YM150 group

EXPERIMENTAL
Drug: YM150

Interventions

YM150DRUG

oral

YM150 group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
  • Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
  • Written informed consent obtained

You may not qualify if:

  • Subject has history of deep vein thrombosis and/or pulmonary embolism
  • Subject has a hemorrhagic disorder and/or coagulation disorder
  • Subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent
  • Subject has an acute bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg
  • Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Venous ThromboembolismHemorrhageVenous Thrombosis

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosis

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 16, 2010

Record last verified: 2010-06

Locations

JP(5)