Trial Condition(s):

Venous Thromboembolism

Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

Bayer Identifier:

11528

ClinicalTrials.gov Identifier:

NCT00395772

EudraCT Number:

2004-002171-16

Study Completed

Trial Purpose

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

Inclusion Criteria
- Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
- Written informed consent
Exclusion Criteria
- Legal lower age limitations (country specific) 
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- Other indication for VKA than PE/DVT
- More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
- Participation in another pharmacotherapeutic study within the prior 30 days
- Creatinine clearance < 30 mL/min, impaired liver function (transaminases > 2 x ULN), or bacterial endocarditis
- Life expectancy < 3 months
- Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin 
- Uncontrolled hypertension: systolic blood pressure > 200 mmHg and diastolic blood pressure > 110 mmHg 
- Pregnancy or childbearing potential without proper contraceptive measures
- Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
- Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study

Trial Summary

Enrollment Goal
543
Trial Dates
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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

SAINT-ETIENNE, France, 42000

Status
Completed
 
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Investigative Site

Göteborg, Sweden, 416 85

Status
Completed
 
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Investigative Site

Johannesburg, South Africa, 2132

Status
Completed
 
Locations

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Plzen, Czech Republic, 323 33

Status
Completed
 
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Brædstrup, Denmark, 8740

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75475

Status
Completed
 
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Tel Aviv, Israel, 64239

Status
Completed
 
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Warszawa, Poland, 02-097

Status
Completed
 
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Garran, Australia, 2605

Status
Completed
 
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Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
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Investigative Site

MONTPELLIER CEDEX, France, 34295

Status
Completed
 
Locations

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Milano, Italy, 20122

Status
Completed
 
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AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
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Wroclaw, Poland, 51-124

Status
Completed
 
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Ostrava-Poruba, Czech Republic, 708 52

Status
Completed
 
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Kfar Saba, Israel, 4428164

Status
Completed
 
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Kogarah, Australia, 2217

Status
Completed
 
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Halifax, Canada, B3H 2Y9

Status
Completed
 
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Prague 5, Czech Republic, 150 00

Status
Completed
 
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Aarhus, Denmark, 8000

Status
Completed
 
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Haifa, Israel, 3109601

Status
Completed
 
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Pavia, Italy, 27100

Status
Completed
 
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GRONINGEN, Netherlands, 9713 GZ

Status
Completed
 
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Warszawa, Poland, 01-138

Status
Completed
 
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Prahran, Australia, 3181

Status
Completed
 
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Padova, Italy, 35128

Status
Completed
 
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AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
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Jönköping, Sweden, 551 85

Status
Completed
 
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Johannesburg, South Africa, 2193

Status
Completed
 
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London, Canada, N6A 4G5

Status
Completed
 
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Frederiksberg, Denmark, 2000

Status
Completed
 
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Holon, Israel, 58100

Status
Completed
 
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Västervik, Sweden, 593 81

Status
Completed
 
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Usti nad Lebem, Czech Republic, 401 13

Status
Completed
 
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VALENCIENNES CEDEX, France, 59322

Status
Completed
 
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MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 
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Clayton, Australia, 3168

Status
Completed
 
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Karlovy Vary, Czech Republic, 360 00

Status
Completed
 
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Afula, Israel, 1834111

Status
Completed
 
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Venezia, Italy, 30122

Status
Completed
 
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Box Hill, Australia, 3128

Status
Completed
 
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GRENOBLE, France, 38043

Status
Completed
 
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Ashkelon, Israel, 7830604

Status
Completed
 
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Ramat Gan, Israel, 52482

Status
Completed
 
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SITTARD, Netherlands, 6131 BK

Status
Completed
 
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HOOFDDORP, Netherlands, 2134 TM

Status
Completed
 
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ARNHEM, Netherlands, 6815 AD

Status
Completed
 
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Petah Tikva, Israel, 4941492

Status
Completed
 
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Investigative Site

Stockholm, Sweden, 118 83

Status
Completed
 
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Johannesburg, South Africa

Status
Completed
 
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St Leonards, Australia, 2065

Status
Completed
 
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Edmonton, Canada, T6G 2H7

Status
Completed
 
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Investigative Site

PARIS CEDEX 15, France, 75908

Status
Completed
 
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Investigative Site

Milano, Italy, 20142

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50-326

Status
Completed
 
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Investigative Site

Johannesburg, South Africa, 2191

Status
Completed
 
Locations

Investigative Site

Woolloongabba, Australia, 4102

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Bydgoszcz, Poland, 85-168

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Investigative Site

Gauteng, South Africa, 2157

Status
Completed
 
Locations

Investigative Site

BREST CEDEX, France, 29609

Status
Completed
 
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Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Investigative Site

Praha 10, Czech Republic, 10034

Status
Completed
 
Locations

Investigative Site

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98122

Status
Completed
 
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Investigative Site

Chapel Hill, United States, 27599-7035

Status
Completed
 
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Investigative Site

Curitiba, Brazil, 80050-350

Status
Completed
 
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Investigative Site

AMERSFOORT, Netherlands, 3818 TZ

Status
Completed
 
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Investigative Site

Zefat, Israel, 1311001

Status
Completed
 
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Investigative Site

Haifa, Israel, 3339419

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3436212

Status
Completed
 
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Investigative Site

Fredericksburg, United States, 22401

Status
Completed
 
Locations

Investigative Site

Albuquerque, United States, 87108

Status
Completed
 
Locations

Investigative Site

Albuquerque, United States, 87131

Status
Completed
 
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Investigative Site

São Paulo, Brazil, 01323-001

Status
Completed
 
Locations

Investigative Site

Sorocaba, Brazil

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90470 340

Status
Completed
 

Trial Design