Clinical trial NCT00839163: Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Official title: ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thrombosis
Deep Vein Thrombosis
Keywords: Embolism and Thrombosis
Pulmonary embolism
Embolism
Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.


Eligibility criteria: Inclusion Criteria:

- Patients with acute symptomatic proximal deep vein thrombosis

Exclusion Criteria:

* Contraindication to comparator drugs
* Symptomatic Pulmonary embolism
* Conditions with increased bleeding risk
* Unstable patients with reduced life expectancy
* Severe renal impairment
* Impaired liver function
* Strong CYP 3A4 inhibitors
* Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
* NSAIDs with half-life \> 17 hours

Primary outcomes:
measure: Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
timeFrame: 21 days
Secondary outcomes:
measure: Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
timeFrame: Day 21
measure: Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
timeFrame: Day 84
measure: Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
timeFrame: Day 1-84
measure: Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period
timeFrame: Day 1-84
measure: Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug
timeFrame: Day 1-114
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Graz
country: Austria
state: Steiermark
city: Wien
country: Austria
city: Wien
country: Austria
city: Duffel
country: Belgium
city: Leuven
country: Belgium
city: Sao Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Barranquilla
country: Colombia
city: Bogotá
country: Colombia
city: Medellín
country: Colombia
city: Brno
country: Czechia
city: Kladno
country: Czechia
city: Ostrava
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 2
country: Czechia
city: Praha 6
country: Czechia
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Karlsbad
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Bergisch Gladbach
country: Germany
state: Nordrhein-Westfalen
city: Paderborn
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szentes
country: Hungary
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Tel Aviv
country: Israel
city: Rozzano
country: Italy
state: Milano
city: Bologna
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Perugia
country: Italy
city: Piacenza
country: Italy
city: Reggio Emilia
country: Italy
city: Varese
country: Italy
city: Arnhem
country: Netherlands
city: Den Bosch
country: Netherlands
city: Den Haag
country: Netherlands
city: Dirksland
country: Netherlands
city: Enschede
country: Netherlands
city: Leidschendam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Lima Cercado
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bialystok
country: Poland
city: Bytom
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Bloemfontein
country: South Africa
state: Freestate
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Cape Town
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Badalona
country: Spain
state: Barcelona
city: Olot
country: Spain
state: Girona
city: La Laguna
country: Spain
state: Tenerife
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Jönköping
country: Sweden
city: Lund
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Luzern
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: