Trial Condition(s):

Venous Thromboembolism

An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism after Total Knee Replacement: a Dose-Ranging Study

Bayer Identifier:

10945

ClinicalTrials.gov Identifier:

NCT00402467

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.

Inclusion Criteria
- Male subjects aged 18 years or above and postmenopausal female subjects
- Subjects scheduled for elective total knee replacement
- Subjects written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures
Exclusion Criteria
Related to medical history:
- Any prior DVT or PE
- Myocardial infarction (MI), TIA or ischaemic stroke within the last 6 months prior to randomization
- History of heparin-induced thrombocytopenia, allergy to heparins
- Intracerebral or intraocular bleeding within the last 6 months prior to randomization
- History of gastrointestinal disease (e.g. active peptic ulcer) with gastrointestinal bleeding within the last 6 months prior to randomization
- History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug (e.g. severe active inflammatory bowel disease, short gut syndrome)
- Amputation of one leg

 Related to current symptoms or findings:
 -- Heart insufficiency NYHA III-IV
 -- Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits)including patients with acquired or congenital thrombophilia
- Thrombocytopenia (platelets < 100,000/µl)
- Macroscopic haematuria
- Allergy to contrast media
- Severe hypertension (SBP > 200mmHg, DBP >  100 mmHg)
- Impaired liver function (transaminases > 2 x ULN)
- Impaired renal function (serum creatinine > 1.5 x ULN or decreased creatinine clearance < 30ml/min)
- Active malignant disease
- Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding
- Body weight < 45 kg
- Drug- or alcohol- abuse

Related to current treatment:
- Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) and fibrinolytic therapy
- Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrollment. Patient not able to stop ASA therapy will be excluded
- All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed)
- Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole). Azole compounds should be stopped at least four days before enrollment

Miscellaneous:
- Planned intermittent pneumatic compression during active treatment period
- Planned epidural anaesthesia with indwelling epidural catheter (spinal and epidural anaesthesia without indwelling catheter is allowed)
- Therapy with another investigational product within 30 days prior to the start of the study
- Concomitant participation in another trial or study

Removal of Subjects from Study:
A subject who withdraws is one who discontinued a clinical study for any reason.
Subjects may be withdrawn from the study for the following reasons:
- At their own request or at the request of their legally acceptable representative
- If, in the investigator's opinion, continuation in the study would be detrimental to the subject's well-being
- At the specific request of the sponsor

Trial Summary

Enrollment Goal
613
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Birmingham, United States, 35205

Status
Completed
 
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Investigative Site

Welland, Canada, L3B 4W6

Status
Completed
 
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Investigative Site

Phoenix, United States, 85023

Status
Completed
 
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Investigative Site

Red Deer, Canada, T4N 6V7

Status
Completed
 
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Sudbury, Canada, P3E 6C3

Status
Completed
 
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Investigative Site

Sarasota, United States, 34239

Status
Completed
 
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Investigative Site

Winnipeg, Canada, R3A 1M3

Status
Completed
 
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Investigative Site

Lubbock, United States, 79410

Status
Completed
 
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Quebec, Canada, G1J 1Z4

Status
Completed
 
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Decatur, United States, 30033

Status
Completed
 
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Ottawa, Canada, K1H 8L6

Status
Completed
 
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Cincinnati, United States, 45219

Status
Completed
 
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Montreal, Canada, H3G 1A4

Status
Completed
 
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Investigative Site

Aurora, United States, 80011-6798

Status
Completed
 
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Investigative Site

St. Catherines, Canada, L2R 5K3

Status
Completed
 
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Kelowna, Canada, V1Y 1T2

Status
Completed
 
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Vancouver, Canada, V6Z 1Y6

Status
Completed
 
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Toronto, Canada, M3M 2G2

Status
Completed
 
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St. Petersburg, United States, 33703

Status
Completed
 
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Barrie, Canada, L4M 6M2

Status
Completed
 
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Investigative Site

Charlottetown, Canada, C1A 1L2

Status
Completed
 
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Investigative Site

Richmond Hill, Canada, L4C 4Z3

Status
Completed
 
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Investigative Site

La Mesa, United States, 91942

Status
Completed
 
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Investigative Site

Palm Beach Gardens, United States, 33410

Status
Completed
 
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Investigative Site

Torrance, United States, 90502-2004

Status
Completed
 
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Oshawa, Canada, L1G 2B9

Status
Completed
 
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Investigative Site

Peterborough, Canada, K9J 7H8

Status
Completed
 
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Investigative Site

Tucson, United States, 85712

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32216

Status
Completed
 
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Investigative Site

Niagara Falls, Canada, L2G 5X8

Status
Completed
 
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Dallas, United States, 75231

Status
Completed
 
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Investigative Site

Aurora, United States, 80012

Status
Completed
 
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Investigative Site

Edmonton, Canada, T6G 2B7

Status
Completed
 
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Investigative Site

Thunder Bay, Canada, P7B 6V4

Status
Completed
 
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Investigative Site

Kitchener, Canada, N2G 1G3

Status
Completed
 
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Investigative Site

Fredericton, Canada, E3B 5N5

Status
Completed
 
Locations

Investigative Site

Guelph, Canada, N1E 6L9

Status
Terminated
 

Trial Design