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

Thromboembolism Clinical Trial

— PEARL-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408239
• Other study ID #: 150-CL-029
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2006
• Last updated: December 15, 2011
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: December 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationTaiwan: Department of HealthMalaysia: Ministry of HealthPhilippines: Department of HealthSingapore: Health Sciences AuthorityThailand: Ministry of Public HealthIndonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• YM150
Oral
• enoxaparin
Sub cutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Venous thromboembolism and/or bleeds		2 Weeks	Yes
Secondary	Other safety assessments		2 Weeks	No
Secondary	PK, PD variables		2 Weeks	No