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

EU CT Number:

Not Available

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
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

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
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Investigative Site

Plzen, Czech Republic, 323 33

Status
Completed
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Investigative Site

Brædstrup, Denmark, 8740

Status
Completed
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Investigative Site

PARIS, France, 75475

Status
Completed
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Investigative Site

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
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Investigative Site

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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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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Milano, Italy, 20142

Status
Completed
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Wroclaw, Poland, 50-326

Status
Completed
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Johannesburg, South Africa, 2191

Status
Completed
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Investigative Site

Woolloongabba, Australia, 4102

Status
Completed
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Investigative Site

Milano, Italy, 20132

Status
Completed
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Investigative Site

Bydgoszcz, Poland, 85-168

Status
Completed
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Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
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Investigative Site

Gauteng, South Africa, 2157

Status
Completed
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Investigative Site

BREST CEDEX, France, 29609

Status
Completed
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Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
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Investigative Site

Praha 10, Czech Republic, 10034

Status
Completed
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Reggio Emilia, Italy, 42100

Status
Completed
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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
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Investigative Site

Haifa, Israel, 3436212

Status
Completed
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Investigative Site

Fredericksburg, United States, 22401

Status
Completed
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Investigative Site

Albuquerque, United States, 87108

Status
Completed
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Investigative Site

Albuquerque, United States, 87131

Status
Completed
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Investigative Site

São Paulo, Brazil, 01323-001

Status
Completed
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Investigative Site

Sorocaba, Brazil

Status
Completed
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Investigative Site

Porto Alegre, Brazil, 90470 340

Status
Completed

Trial Design