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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00839163




Registration number
NCT00839163
Ethics application status
Date submitted
6/02/2009
Date registered
6/02/2009
Date last updated
27/10/2014

Titles & IDs
Public title
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Scientific 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.
Secondary ID [1] 0 0
2004-001083-43
Secondary ID [2] 0 0
11223
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Enoxaparin/Vitamin K-Antagonist

Experimental: Arm 1 -

Experimental: Arm 2 -

Experimental: Arm 3 -

Experimental: Arm 4 -

Active Comparator: Arm 5 -


Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

Treatment: Drugs: Enoxaparin/Vitamin K-Antagonist
Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Timepoint [1] 0 0
21 days
Secondary outcome [1] 0 0
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Timepoint [1] 0 0
Day 21
Secondary outcome [2] 0 0
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Timepoint [2] 0 0
Day 84
Secondary outcome [3] 0 0
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Timepoint [3] 0 0
Day 1-84
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Day 1-84
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 1-114

Eligibility
Key inclusion criteria
- Patients with acute symptomatic proximal deep vein thrombosis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2217 - Sydney
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment postcode(s) [5] 0 0
3135 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Duffel
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Colombia
State/province [9] 0 0
Barranquilla
Country [10] 0 0
Colombia
State/province [10] 0 0
Bogotá
Country [11] 0 0
Colombia
State/province [11] 0 0
Medellín
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Brno
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Kladno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Plzen
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Praha 10
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 6
Country [19] 0 0
Germany
State/province [19] 0 0
Baden-Württemberg
Country [20] 0 0
Germany
State/province [20] 0 0
Bayern
Country [21] 0 0
Germany
State/province [21] 0 0
Hessen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Sachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Hungary
State/province [26] 0 0
Debrecen
Country [27] 0 0
Hungary
State/province [27] 0 0
Pecs
Country [28] 0 0
Hungary
State/province [28] 0 0
Szentes
Country [29] 0 0
Israel
State/province [29] 0 0
Afula
Country [30] 0 0
Israel
State/province [30] 0 0
Ashkelon
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Holon
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Israel
State/province [34] 0 0
Kfar Saba
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Aviv
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Bologna
Country [38] 0 0
Italy
State/province [38] 0 0
Padova
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Italy
State/province [40] 0 0
Perugia
Country [41] 0 0
Italy
State/province [41] 0 0
Piacenza
Country [42] 0 0
Italy
State/province [42] 0 0
Reggio Emilia
Country [43] 0 0
Italy
State/province [43] 0 0
Varese
Country [44] 0 0
Netherlands
State/province [44] 0 0
Arnhem
Country [45] 0 0
Netherlands
State/province [45] 0 0
Den Bosch
Country [46] 0 0
Netherlands
State/province [46] 0 0
Den Haag
Country [47] 0 0
Netherlands
State/province [47] 0 0
Dirksland
Country [48] 0 0
Netherlands
State/province [48] 0 0
Enschede
Country [49] 0 0
Netherlands
State/province [49] 0 0
Leidschendam
Country [50] 0 0
Netherlands
State/province [50] 0 0
Rotterdam
Country [51] 0 0
New Zealand
State/province [51] 0 0
Auckland
Country [52] 0 0
New Zealand
State/province [52] 0 0
Christchurch
Country [53] 0 0
Peru
State/province [53] 0 0
Lima Cercado
Country [54] 0 0
Peru
State/province [54] 0 0
Lima
Country [55] 0 0
Poland
State/province [55] 0 0
Bialystok
Country [56] 0 0
Poland
State/province [56] 0 0
Bytom
Country [57] 0 0
Poland
State/province [57] 0 0
Gdansk
Country [58] 0 0
Poland
State/province [58] 0 0
Katowice
Country [59] 0 0
Poland
State/province [59] 0 0
Lublin
Country [60] 0 0
Poland
State/province [60] 0 0
Olsztyn
Country [61] 0 0
Poland
State/province [61] 0 0
Poznan
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
South Africa
State/province [63] 0 0
Freestate
Country [64] 0 0
South Africa
State/province [64] 0 0
Gauteng
Country [65] 0 0
South Africa
State/province [65] 0 0
Western Cape
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona
Country [67] 0 0
Spain
State/province [67] 0 0
Girona
Country [68] 0 0
Spain
State/province [68] 0 0
Tenerife
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
Sweden
State/province [71] 0 0
Göteborg
Country [72] 0 0
Sweden
State/province [72] 0 0
Halmstad
Country [73] 0 0
Sweden
State/province [73] 0 0
Jönköping
Country [74] 0 0
Sweden
State/province [74] 0 0
Lund
Country [75] 0 0
Switzerland
State/province [75] 0 0
Basel
Country [76] 0 0
Switzerland
State/province [76] 0 0
Bern
Country [77] 0 0
Switzerland
State/province [77] 0 0
Luzern
Country [78] 0 0
Switzerland
State/province [78] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00839163
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications