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AzTrials

Venous ThrombosisPhase 2NCT00839163

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and Enoxaparin/Vitamin K-Antagonist in people with Venous Thrombosis and Deep Vein Thrombosis, run by Bayer at 110 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thrombosis, Deep Vein Thrombosis
What is being tested?
Xarelto (Rivaroxaban, BAY59-7939) and Enoxaparin/Vitamin K-Antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
613 participants
Where
110 sitesin 19 countries
Study dates
Mar 2004to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with acute symptomatic proximal deep vein thrombosis

Who cannot join

  • Contraindication to comparator drugs
  • Symptomatic Pulmonary embolism
  • Conditions with increased bleeding risk
  • Unstable patients with reduced life expectancy
  • Severe renal impairment
  • Impaired liver function
Show all 9Show fewer
  • Strong CYP 3A4 inhibitors
  • Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
  • NSAIDs with half-life > 17 hours

Trial locations and contacts

110 sites in 19 countries.

110 sites in 19 countries

Canada11 sites

  • Study site

    Greater Sudbury, Ontario, P3E 3B5

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3T 1M5

  • Study site

    North Bay, Ontario, P1B 5A4

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Toronto, Ontario, M3N 1N1

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Windsor, Ontario, N8X 3V6

Other trials in Canada

Germany10 sites

  • Study site

    Bergisch Gladbach, North Rhine-Westphalia, 51429

  • Study site

    Berlin, 10365

  • Study site

    Berlin, 10787

  • Study site

    Darmstadt, Hesse, 64276

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Heidelberg, Baden-Wurttemberg, 69115

  • Study site

    Karlsbad, Baden-Wurttemberg, 76307

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 80336

  • Study site

    Paderborn, North Rhine-Westphalia, 33098

Other trials in Germany

Italy10 sites

  • Study site

    Bologna, 40138

  • Study site

    Milan, 20142

  • Study site

    Milan, 20162

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90129

  • Study site

    Perugia, 06122

  • Study site

    Piacenza, 29100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Rozzano, Milano, 20089

  • Study site

    Varese, 21100

Other trials in Italy

Poland8 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bytom, 41-902

  • Study site

    Gdansk, 80-952

  • Study site

    Katowice, 40-752

  • Study site

    Lublin, 20-718

  • Study site

    Olsztyn, 10-560

  • Study site

    Poznan, 61-833

  • Study site

    Warsaw, 02-097

Other trials in Poland

Spain8 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08036

  • Study site

    Girona, 17007

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28007

  • Study site

    Olot, Girona, 17800

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Valencia, 46010

Other trials in Spain

Australia7 sites

  • Study site

    Adelaide, South Australia, 5011

  • Study site

    Adelaide, South Australia, 5042

  • Study site

    Melbourne, Victoria, 3128

  • Study site

    Melbourne, Victoria, 3135

  • Study site

    Melbourne, Victoria, 3181

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Sydney, New South Wales, 2217

Other trials in Australia

Czechia7 sites

  • Study site

    Brno, 656 91

  • Study site

    Kladno, 27259

  • Study site

    Ostrava, 728 80

  • Study site

    Pilsen, 30599

  • Study site

    Prague, 10034

  • Study site

    Prague, 12808

  • Study site

    Prague, 169 02

Other trials in Czechia

Israel7 sites

  • Study site

    Afula, 18101

  • Study site

    Ashkelon, 78306

  • Study site

    Haifa, 31096

  • Study site

    Holon, 58100

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Netherlands7 sites

  • Study site

    's-Hertogenbosch, 5211 RB

  • Study site

    Arnhem, 6815 AD

  • Study site

    Dirksland, 3247 BW

  • Study site

    Enschede, 7511 JX

  • Study site

    Leidschendam, 2262 BA

  • Study site

    Rotterdam, 3083 AN

  • Study site

    The Hague, 2512 VA

Other trials in Netherlands

South Africa6 sites

  • Study site

    Bloemfontein, Freestate, 9300

  • Study site

    Cape Town, Western Cape, 7531

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0157

  • Study site

    Pretoria, Gauteng, PRETORIA

  • Study site

    Somerset West, Western Cape, 7130

Other trials in South Africa

Sweden5 sites

  • Study site

    Gothenburg, 413 45

  • Study site

    Gothenburg, 416 85

  • Study site

    Halmstad, 301 85

  • Study site

    Jönköping, 551 85

  • Study site

    Lund, 221 85

Other trials in Sweden

Hungary4 sites

  • Study site

    Budapest, 1115

  • Study site

    Debrecen, 4032

  • Study site

    Pécs, 7624

  • Study site

    Szentes, 6600

Other trials in Hungary

Switzerland4 sites

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Lucerne, 6000

  • Study site

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1171

Other trials in Austria

Colombia3 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Medellín

Other trials in Colombia

New Zealand3 sites

  • Study site

    Auckland, 0622

  • Study site

    Auckland, 1023

  • Study site

    Christchurch, 8011

Other trials in New Zealand

Peru3 sites

  • Study site

    Lima, 01

  • Study site

    Lima, 31

  • Study site

    Lima Cercado, LIMA 1

Other trials in Peru

Belgium2 sites

  • Study site

    Duffel, 2570

  • Study site

    Leuven, 3000

Other trials in Belgium

Brazil2 sites

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    São Paulo, São Paulo, 04544 000

Other trials in Brazil

About this study

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.

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.

Being tested
Xarelto (Rivaroxaban, BAY59-7939), Enoxaparin/Vitamin K-Antagonist
Keywords
Embolism and Thrombosis, Pulmonary embolism, Embolism, Thrombosis
Medical subject headings
Venous Thrombosis, Embolism and Thrombosis, Pulmonary Embolism, Embolism, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

  • Enoxaparin/Vitamin K-AntagonistDrug

    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

Study groups in NCT00839163
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 4ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 5Active comparatorNot described
Receives: Drug: Enoxaparin/Vitamin K-Antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to treatment as determined by a Complete Compression Ultra sound (CCUS)

    Measured: 21 days

Secondary outcomes (5)

  1. Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan

    Measured: Day 21

  2. Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)

    Measured: Day 84

  3. Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)

    Measured: Day 1-84

  4. 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

    Measured: Day 1-84

  5. 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

    Measured: Day 1-114

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2009 (estimated)
  2. Study startMar 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
613 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00839163
Sponsor's protocol ID
11223
Other IDs
2004-001083-43, ODIXa-DVT, 2004
Status last verified
Oct 2014
First submitted
6 Feb 2009
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and Enoxaparin/Vitamin K-Antagonist in people with Venous Thrombosis and Deep Vein Thrombosis, run by Bayer at 110 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Canada, Germany, Italy, Poland, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to treatment as determined by a Complete Compression Ultra sound (CCUS) (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00839163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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