check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

11528

ClinicalTrials.gov Identifier:

NCT00395772

EudraCT Number:

2004-002171-16

EU CT Number:

Not Available
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
December 2004 - December 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
SAINT-ETIENNE, 42000, France
Completed
Göteborg, 416 85, Sweden
Completed
Johannesburg, 2132, South Africa
Completed
Plzen, 323 33, Czech Republic
Completed
Brædstrup, 8740, Denmark
Completed
PARIS, 75475, France
Completed
Tel Aviv, 64239, Israel
Completed
Warszawa, 02-097, Poland
Completed
Garran, 2605, Australia
Completed
Hradec Kralove, 500 05, Czech Republic
Completed
MONTPELLIER CEDEX, 34295, France
Completed
Milano, 20122, Italy
Completed
AMSTERDAM, 1081 HV, Netherlands
Completed
Wroclaw, 51-124, Poland
Completed
Ostrava-Poruba, 708 52, Czech Republic
Completed
Kfar Saba, 4428164, Israel
Completed
Kogarah, 2217, Australia
Completed
Halifax, B3H 2Y9, Canada
Completed
Prague 5, 150 00, Czech Republic
Completed
Aarhus, 8000, Denmark
Completed
Haifa, 3109601, Israel
Completed
Pavia, 27100, Italy
Completed
GRONINGEN, 9713 GZ, Netherlands
Completed
Warszawa, 01-138, Poland
Completed
Prahran, 3181, Australia
Completed
Padova, 35128, Italy
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
Jönköping, 551 85, Sweden
Completed
Johannesburg, 2193, South Africa
Completed
London, N6A 4G5, Canada
Completed
Frederiksberg, 2000, Denmark
Completed
Holon, 58100, Israel
Completed
Västervik, 593 81, Sweden
Completed
Usti nad Lebem, 401 13, Czech Republic
Completed
VALENCIENNES CEDEX, 59322, France
Completed
MAASTRICHT, 6229 HX, Netherlands
Completed
Clayton, 3168, Australia
Completed
Karlovy Vary, 360 00, Czech Republic
Completed
Afula, 1834111, Israel
Completed
Venezia, 30122, Italy
Completed
Box Hill, 3128, Australia
Completed
GRENOBLE, 38043, France
Completed
Ashkelon, 7830604, Israel
Completed
Ramat Gan, 52482, Israel
Completed
SITTARD, 6131 BK, Netherlands
Completed
HOOFDDORP, 2134 TM, Netherlands
Completed
ARNHEM, 6815 AD, Netherlands
Completed
Petah Tikva, 4941492, Israel
Completed
Stockholm, 118 83, Sweden
Completed
Johannesburg, South Africa
Completed
St Leonards, 2065, Australia
Completed
Edmonton, T6G 2H7, Canada
Completed
PARIS CEDEX 15, 75908, France
Completed
Milano, 20142, Italy
Completed
Wroclaw, 50-326, Poland
Completed
Johannesburg, 2191, South Africa
Completed
Woolloongabba, 4102, Australia
Completed
Milano, 20132, Italy
Completed
Bydgoszcz, 85-168, Poland
Completed
Stockholm, 171 76, Sweden
Completed
Gauteng, 2157, South Africa
Completed
BREST CEDEX, 29609, France
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
Praha 10, 10034, Czech Republic
Completed
Reggio Emilia, 42100, Italy
Completed
Seattle, 98122, United States
Completed
Chapel Hill, 27599-7035, United States
Completed
Curitiba, 80050-350, Brazil
Completed
AMERSFOORT, 3818 TZ, Netherlands
Completed
Zefat, 1311001, Israel
Completed
Haifa, 3339419, Israel
Completed
Haifa, 3436212, Israel
Completed
Fredericksburg, 22401, United States
Completed
Albuquerque, 87108, United States
Completed
Albuquerque, 87131, United States
Completed
São Paulo, 01323-001, Brazil
Completed
Sorocaba, Brazil
Completed
Porto Alegre, 90470 340, Brazil
Withdrawn
Montreal, H3T 1E2, Canada
Withdrawn
Hørsholm, DK-2970, Denmark
Withdrawn
LEIDEN, 2333 ZA, Netherlands
Withdrawn
Toronto, M5G 2N2, Canada

Primary Outcome

  • The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks.
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No

Secondary Outcome

  • The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks.
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • The separate components of the primary efficacy outcome at 12 weeks.
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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