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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00839163




Registration number
NCT00839163
Ethics application status
Date submitted
6/02/2009
Date registered
9/02/2009
Date last updated
7/09/2023

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
Sex
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
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
613
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
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Kladno
Country [14] 0 0
Czechia
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czechia
State/province [15] 0 0
Plzen
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 10
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czechia
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00839163