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

Completed · Phase 2

Conditions studied: Venous Thromboembolism

In brief

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 facts

Study ID

NCT00395772

Run by

Bayer

People needed

543

Starts

2004-12-01

Expected to finish

2005-12-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Albuquerque, New Mexico, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Fredericksburg, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Canberra, Australian Capital Territory, Australia
• Study site — Sydney, New South Wales, Australia
• Study site — Sydney, New South Wales, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Curitiba, Paraná, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — Sorocaba, São Paulo, Brazil
• Study site — Edmonton, Alberta, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — London, Ontario, Canada
• Study site — Hradec Králové, Czechia
• Study site — Karlovy Vary, Czechia
• Study site — Ostrava, Czechia
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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