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

Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement (PEARL-1)

This study has been completed.

First Received on December 4, 2006. Last Updated on December 15, 2011 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00408239

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

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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Enoxaparin Sodium YM150

U.S. FDA Resources

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 ]

Enrollment:	367
Study Start Date:	December 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

Locations

Indonesia

Jakarta, Indonesia, 14460
Japan

Chubu region, Japan

Chugoku region, Japan

Kansai region, Japan

Kanto region, Japan

Kyushyu region, Japan

Shikoku region, Japan

Tohoku region, Japan
Korea, Republic of

In Cheon, Korea, Republic of, 405-760

Jeonnam, Korea, Republic of, 519-809

Seoul, Korea, Republic of, 110-744
Malaysia

Kelantan, Malaysia, 16150

Kuala Lumpur, Malaysia, 59100
Philippines

Manila, Philippines, 1008

Quezon City, Philippines, 1114
Singapore

Singapore, Singapore
Taiwan

Kaohsiung, Taiwan, 833
Thailand

Bangkok, Thailand

Chiang Mai, Thailand, 50200

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00408239 History of Changes
Other Study ID Numbers:	150-CL-029
Study First Received:	December 4, 2006
Last Updated:	December 15, 2011
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

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012