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Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement

NCT00641732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1045

Last updated 2016-04-13

No results posted yet for this study

Summary

The purpose of this study is to determine if TAK-442, once daily (QD) or twice daily (BID), is as safe and effective as enoxaparin in preventing the development of blood clots after knee replacement surgery.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

TAK-442

TAK-442 40 mg, tablets, orally, once daily for up to 10 days.

DRUG

TAK-442

TAK-442 80 mg, tablets, orally, once daily for up to 10 days.

DRUG

TAK-442

TAK-442 10 mg, tablets, orally, twice daily for up to 10 days.

DRUG

TAK-442

TAK-442 20 mg, tablets, orally, twice daily for up to 10 days.

DRUG

TAK-442

TAK-442 40mg, tablets, orally, twice daily for up to 10 days.

DRUG

TAK-442

TAK-442 80 mg, tablets, orally, twice daily for up to 10 days.

DRUG

Enoxaparin

Enoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.

Sponsors & Collaborators

Principal Investigators

  • Executive Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00641732 on ClinicalTrials.gov