ThromboEmbolism Prevention Efficacy and Safety Trial (TEM... | NCT00041509

Studies
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

NCT00041509

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

343Actual

Phase

Phase 2

Conditions

Arthroplasty

Interventions

SB-424323
Placebo

Countries

Not provided

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2002

Primary Completion Date

May 2003Actual

Completion Date

May 2003Actual

First Submitted Date

Jul 9, 2002

First Submission Date that Met QC Criteria

Jul 11, 2002

First Posted Date

Jul 12, 2002Estimated

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

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

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 purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

343Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SB424323, 500 mg BID	Experimental	Drug: SB-424323
SB424323, 125 mg BID	Experimental	Drug: SB-424323
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB-424323	Drug	500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days	SB424323, 125 mg BID SB424323, 500 mg BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VTE	Incidence of VTE during the 28-day treatment period, including death due to VTE	28 day treatment period

Secondary Outcomes

Measure	Description	Time Frame
types of VTE	The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity	28 day treatment period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
Patients who have given written informed consent to participate in this study.

Exclusion Criteria:

Patients with a contraindication to contrast venography
Patients with an increased risk of bleeding.
Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism
D013923	Thromboembolism
D011655	Pulmonary Embolism
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided