Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement - Tabular View

Tracking Information

First Received Date ^ICMJE

December 4, 2006

Last Updated Date

April 20, 2009

Start Date ^ICMJE

December 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00408239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Venous thromboembolism and/or bleeds [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
Other safety assessments [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
PK, PD variables [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Venous thromboembolism, bleedings, other safety assessments,
PK, PD variables

Descriptive Information

Brief Title ^ICMJE

Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement

Official Title ^ICMJE

Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-Controlled, Open Label, Dose-Escalation Study

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Thromboembolism

Intervention ^ICMJE

Drug: YM150
Drug: enoxaparin

Study Arms / Comparison Groups

Experimental: Dose regimen 1
Experimental: Dose regimen 2

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

367

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Indonesia, Japan, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00408239

Responsible Party

Director, Astellas Pharma, Inc

Study ID Numbers ^ICMJE

150-CL-029

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP