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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site SAINT-ETIENNE, France, 42000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plzen, Czech Republic, 323 33 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brædstrup, Denmark, 8740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Garran, Australia, 2605 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 51-124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava-Poruba, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kogarah, Australia, 2217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halifax, Canada, B3H 2Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prague 5, Czech Republic, 150 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frederiksberg, Denmark, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Västervik, Sweden, 593 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Usti nad Lebem, Czech Republic, 401 13 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VALENCIENNES CEDEX, France, 59322 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlovy Vary, Czech Republic, 360 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Venezia, Italy, 30122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRENOBLE, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 52482 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SITTARD, Netherlands, 6131 BK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOFDDORP, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARNHEM, Netherlands, 6815 AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 2H7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-326 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2191 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woolloongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gauteng, South Africa, 2157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST CEDEX, France, 29609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chapel Hill, United States, 27599-7035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Curitiba, Brazil, 80050-350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMERSFOORT, Netherlands, 3818 TZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zefat, Israel, 1311001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3339419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fredericksburg, United States, 22401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 01323-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sorocaba, Brazil | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90470 340 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 12 weeks
Secondary Outcome
- The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks.Timeframe: 12 weeks
- The separate components of the primary efficacy outcome at 12 weeks.Timeframe: 12 weeks
Additional Information
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