NCT00041509

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

July 9, 2002

Last Update Submit

May 24, 2017

Conditions

Arthroplasty

Keywords

venous thromboembolismthromboembolismpulmonary embolismdeep vein thrombosis

Outcome Measures

Primary Outcomes (1)

  • VTE

    Incidence of VTE during the 28-day treatment period, including death due to VTE

    28 day treatment period

Secondary Outcomes (1)

  • types of VTE

    28 day treatment period

Study Arms (3)

SB424323, 500 mg BID

EXPERIMENTAL
Drug: SB-424323

SB424323, 125 mg BID

EXPERIMENTAL
Drug: SB-424323

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SB-424323DRUG

500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

SB424323, 125 mg BIDSB424323, 500 mg BID
PlaceboDRUG

matching placebo, oral, BID for 28 days

Placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous ThromboembolismThromboembolismPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThrombosis

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2002

First Posted

July 12, 2002

Study Start

January 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

May 30, 2017

Record last verified: 2017-05