Prevention of Venous Thromboembolism in Subjects Undergoi... | NCT00937911

Studies
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

NCT00937911

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jun 16, 2010Estimated

Enrollment

101Actual

Phase

Phase 3

Conditions

Venous Thromboembolism

Interventions

YM150

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2010

Last Update Posted Date

Jun 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Label	Type	Description	Intervention Names
YM150 group	Experimental		Drug: YM150

Name	Type	Description	Arm Group Labels	Other Names
YM150	Drug	oral	YM150 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of venous thromboembolism		Until day 12

Secondary Outcomes

Measure	Description	Time Frame
Incidence of deep vein thrombosis		Until day 35
Incidence of pulmonary embolism		Until day 35
All cause mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
Written informed consent obtained before screening

Exclusion Criteria:

Subject has history of deep vein thrombosis and/or pulmonary embolism
Subject has a hemorrhagic disorder and/or coagulation disorder
Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
Subject has an acute bacterial endocarditis
Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
Subject is receiving anticoagulants/antiplatelet agents
Subject has a body weight less than 40 kg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism
D006470	Hemorrhage

Ancestor Terms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chugoku			Japan