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

Completed · Phase 2

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00641732

Run by

Takeda

People needed

1045

Starts

2007-10-01

Expected to finish

2008-10-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo elective, unilateral, primary, total knee replacement.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Screening laboratory tests (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory or are determined not to compromise subject safety by the investigator.

You may not qualify if…

• Received TAK-442 in a previous clinical study or as a therapeutic agent.
• Body weight greater than 150 kg.
• Known bleeding diathesis (including Von Willebrand's disease or Hemophilia A or B).
• History of intracerebral, intraocular, or gastrointestinal bleeding, or active gastric or duodenal ulceration, within the 6 months prior to Randomization.
• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including throughout the treatment period of the study due to an increased risk of bleeding, and should be stopped at least 5 days prior to surgery and in accordance with the product information:
• Parenteral anticoagulants
• Unfractionated heparin
• Low molecular weight heparin (eg, dalteparin, non-study enoxaparin)
• Direct thrombin inhibitors (eg, bivalirudin, argatroban)
• Factor Xa inhibitors (eg, fondaparinux)
• Oral anticoagulants
• Warfarin
• Anisindione
• Antiplatelet drugs
• Aspirin greater than 162 mg/day
• Clopidogrel
• Ticlopidine
• Cilostazol
• Dipyridamole
• Glycoprotein IIb/IIIa inhibitors (eg, abciximab, eptifibatide)
• NSAIDs with a half life greater than or equal to 17 hours
• Meloxicam
• Fibrinolytic agents
• tPA (alteplase, reteplase, tenecteplase)
• History of major surgery within 3 months prior to randomization; or deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.

Where it is running

• Study site — Tuscaloosa, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Montclair, California, United States
• Study site — Oceanside, California, United States
• Study site — Vista, California, United States
• Study site — Yuba City, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Centennial, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Bay Pines, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Gulf Breeze, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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