NCT00937911

Brief Summary

The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
9 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

10 months

First QC Date

July 9, 2009

Last Update Submit

June 14, 2010

Conditions

Venous Thromboembolism

Keywords

YM150BleedingAnticoagulantVenous thromboembolismFXa inhibitor

Outcome Measures

Primary Outcomes (1)

  • Incidence of venous thromboembolism

    Until day 12

Secondary Outcomes (4)

  • Incidence of deep vein thrombosis

    Until day 35

  • Incidence of pulmonary embolism

    Until day 35

  • All cause mortality

    Until day 35

  • Incidence of bleeding event

    Until day 35

Study Arms (1)

YM150 group

EXPERIMENTAL
Drug: YM150

Interventions

YM150DRUG

oral

YM150 group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
  • Written informed consent obtained before screening

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 the screening visit
  • Subject has an acute bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Venous ThromboembolismHemorrhage

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 16, 2010

Record last verified: 2010-06

Locations

JP(8)