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

September 6, 2023 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
613

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2217
    • South Australia
      • Adelaide, South Australia, Australia, 5042
      • Adelaide, South Australia, Australia, 5011
    • Victoria
      • Melbourne, Victoria, Australia, 3135
      • Melbourne, Victoria, Australia, 3128
      • Melbourne, Victoria, Australia, 3181
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Austria
      • Wien, Austria, 1090
      • Wien, Austria, 1171
    • Steiermark
      • Graz, Steiermark, Austria, 8036
  • Belgium
      • Duffel, Belgium, 2570
      • Leuven, Belgium, 3000
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04544 000
      • São Paulo, SP, Brazil, 01323-001
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton, Ontario, Canada, L8N 4A6
      • North Bay, Ontario, Canada, P1B 5A4
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Sudbury, Ontario, Canada, P3E 3B5
      • Toronto, Ontario, Canada, M3N 1N1
      • Windsor, Ontario, Canada, N8X 3V6
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
      • Montreal, Quebec, Canada, H2W 1T8
  • Colombia
      • Barranquilla, Colombia
      • Bogotá, Colombia
      • Medellín, Colombia
  • Czechia
      • Brno, Czechia, 656 91
      • Kladno, Czechia, 27259
      • Ostrava, Czechia, 728 80
      • Plzen, Czechia, 30599
      • Praha 10, Czechia, 10034
      • Praha 2, Czechia, 12808
      • Praha 6, Czechia, 169 02
  • Germany
      • Berlin, Germany, 10787
      • Berlin, Germany, 10365
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69115
      • Karlsbad, Baden-Württemberg, Germany, 76307
      • Mannheim, Baden-Württemberg, Germany, 68167
    • Bayern
      • München, Bayern, Germany, 80336
    • Hessen
      • Darmstadt, Hessen, Germany, 64276
    • Nordrhein-Westfalen
      • Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
      • Paderborn, Nordrhein-Westfalen, Germany, 33098
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
  • Hungary
      • Budapest, Hungary, 1115
      • Debrecen, Hungary, 4032
      • Pecs, Hungary, 7624
      • Szentes, Hungary, 6600
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78306
      • Haifa, Israel, 31096
      • Holon, Israel, 58100
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Tel Aviv, Israel, 64239
  • Italy
      • Bologna, Italy, 40138
      • Milano, Italy, 20162
      • Milano, Italy, 20142
      • Padova, Italy, 35128
      • Palermo, Italy, 90129
      • Perugia, Italy, 06122
      • Piacenza, Italy, 29100
      • Reggio Emilia, Italy, 42100
      • Varese, Italy, 21100
    • Milano
      • Rozzano, Milano, Italy, 20089
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
      • Den Bosch, Netherlands, 5211 RB
      • Den Haag, Netherlands, 2512 VA
      • Dirksland, Netherlands, 3247 BW
      • Enschede, Netherlands, 7511 JX
      • Leidschendam, Netherlands, 2262 BA
      • Rotterdam, Netherlands, 3083 AN
  • New Zealand
      • Auckland, New Zealand, 1023
      • Auckland, New Zealand, 0622
      • Christchurch, New Zealand, 8011
  • Peru
      • Lima, Peru, 01
      • Lima, Peru, 31
      • Lima Cercado, Peru, LIMA 1
  • Poland
      • Bialystok, Poland, 15-276
      • Bytom, Poland, 41-902
      • Gdansk, Poland, 80-952
      • Katowice, Poland, 40-752
      • Lublin, Poland, 20-718
      • Olsztyn, Poland, 10-560
      • Poznan, Poland, 61-833
      • Warszawa, Poland, 02-097
  • South Africa
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9300
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0084
      • Pretoria, Gauteng, South Africa, 0157
      • Pretoria, Gauteng, South Africa, PRETORIA
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7531
      • Somerset West, Western Cape, South Africa, 7130
  • Spain
      • Barcelona, Spain, 08036
      • Girona, Spain, 17007
      • Madrid, Spain, 28006
      • Madrid, Spain, 28007
      • Valencia, Spain, 46010
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
    • Girona
      • Olot, Girona, Spain, 17800
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
  • Sweden
      • Göteborg, Sweden, 416 85
      • Göteborg, Sweden, 413 45
      • Halmstad, Sweden, 301 85
      • Jönköping, Sweden, 551 85
      • Lund, Sweden, 221 85
  • Switzerland
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3010
      • Luzern, Switzerland, 6000
      • Zürich, Switzerland, 8091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Drug: 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).
Drug: 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).
Drug: 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).
Drug: 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).
Experimental: Arm 2
Drug: 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).
Drug: 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).
Drug: 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).
Drug: 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).
Experimental: Arm 3
Drug: 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).
Drug: 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).
Drug: 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).
Drug: 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).
Experimental: Arm 4
Drug: 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).
Drug: 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).
Drug: 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).
Drug: 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).
Active Comparator: Arm 5
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Time Frame: 21 days
21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Time Frame: Day 21
Day 21
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Time Frame: Day 84
Day 84
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Time Frame: Day 1-84
Day 1-84
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
Time Frame: Day 1-84
Day 1-84
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
Time Frame: Day 1-114
Day 1-114

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11223 (FUNDESALUD)
  • 2004-001083-43 (EudraCT Number)
  • ODIXa-DVT (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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