NCT00408239

Brief Summary

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

Trial Health

93
On Track

Trial Health Score

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

Enrollment
367

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
8 countries

19 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

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

2.2 years

First QC Date

December 4, 2006

Last Update Submit

December 15, 2011

Conditions

Thromboembolism

Keywords

Factor Xa inhibitorThromboembolismArthroplastyKnee ReplacementPrevention and Control

Outcome Measures

Primary Outcomes (1)

  • All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment

    2 Weeks

Secondary Outcomes (3)

  • Venous thromboembolism and/or bleeds

    2 Weeks

  • Other safety assessments

    2 Weeks

  • PK, PD variables

    2 Weeks

Study Arms (3)

1

EXPERIMENTAL

Dose regimen 1

Drug: YM150

2

ACTIVE COMPARATOR
Drug: enoxaparin

3

EXPERIMENTAL

Dose regimen 2

Drug: YM150

Interventions

YM150DRUG

Oral

13
enoxaparinDRUG

Sub cutaneous

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective primary total knee replacement surgery
  • Legal minimum age requirement ( country-specific)
  • Written informed consent has been obtained

You may not qualify if:

  • Documented history or considered to be at increased risk of venous thromboembolism
  • Subjects considered to be at increased risk of bleeding:
  • Known hemorrhagic disorder and/or coagulation disorder
  • Thrombocytopenia
  • Clinically important bleeding occurred within 3 months prior to the screening visit
  • Acute bacterial endocarditis
  • Severe hypertension
  • Retinopathy
  • Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Jakarta, 14460, Indonesia

Location

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushyu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Unknown Facility

Kelantan, 16150, Malaysia

Location

Unknown Facility

Kuala Lumpur, 59100, Malaysia

Location

Unknown Facility

Manila, 1008, Philippines

Location

Unknown Facility

Quezon City, 1114, Philippines

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Incheon, 405-760, South Korea

Location

Unknown Facility

Jeonnam, 519-809, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Kaohsiung City, 833, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 6, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

JP(7)PH(2)KR(3)SG(1)TW(1)ID(1)MY(2)TH(2)