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

Purpose

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

Condition	Intervention	Phase
Thromboembolism	Drug: YM150 Drug: enoxaparin	Phase II

MedlinePlus related topics:

Knee Replacement

Drug Information available for:

Enoxaparin Sodium Antithrombin III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose regimen 1	Drug: YM150 Oral
2: Active Comparator	Drug: enoxaparin Sub cutaneous
3: Experimental Dose regimen 2	Drug: YM150 Oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408239

Contacts


Contact: Clinical Development Administration Dept. Astellas Pharma, Inc		clinicaltrials_info@jp.astellas.com

Locations


Indonesia
		Recruiting
	Jakarta, Indonesia, 14460

Japan
		Recruiting
	Tohoku region, Japan
		Recruiting
	Kanto region, Japan
		Recruiting
	Chubu region, Japan
		Recruiting
	Kansai region, Japan
		Recruiting
	Chugoku region, Japan
		Recruiting
	Shikoku region, Japan
		Recruiting
	Kyushyu region, Japan

Korea, Republic of
		Recruiting
	Seoul, Korea, Republic of, 110-744
		Recruiting
	In Cheon, Korea, Republic of, 405-760
		Recruiting
	Jeonnam, Korea, Republic of, 519-809

Malaysia
		Recruiting
	Kuala Lumpur, Malaysia, 59100
		Recruiting
	Kelantan, Malaysia, 16150

Philippines
		Recruiting
	Manila, Philippines, 1008
		Recruiting
	Quezon City, Philippines, 1114

Singapore
		Recruiting
	Singapore, Singapore

Taiwan
		Recruiting
	Kaohsiung, Taiwan, 833

Thailand
		Recruiting
	Bangkok, Thailand
		Recruiting
	Chiang Mai, Thailand, 50200

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Chair:	Central Contact	Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc ( Director )
Study ID Numbers:	150-CL-029
First Received:	December 4, 2006
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00408239
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Korea: Food and Drug Administration; Taiwan: Department of Health; Malaysia: Ministry of Health; Philippines: Department of Health; Singapore: Health Sciences Authority; Thailand: Ministry of Public Health; Indonesia: National Agency of Drug and Food Control

Keywords provided by Astellas Pharma Inc:

Factor Xa inhibitor

Thromboembolism

Arthroplasty

Knee Replacement

Prevention and Control

Study placed in the following topic categories:

Embolism and Thrombosis

Embolism

Vascular Diseases

Venous Thromboembolism

Antithrombin III

Thrombosis

Thromboembolism

Enoxaparin

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00408239