ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial (ODiXaHip)

December 15, 2014 updated by: Bayer

Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

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.
641

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

  • Austria
      • Wien, Austria, 1220
    • Niederösterreich
      • Wiener Neustadt, Niederösterreich, Austria, 2700
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
  • Belgium
      • Baudour, Belgium, 7331
      • Bruxelles, Belgium, 1090
      • Gent, Belgium, 9000
      • HUY, Belgium, 4500
  • Denmark
      • Hellerup, Denmark, 2900
      • Herlev, Denmark, 2730
      • Hørsholm, Denmark, DK-2970
      • Silkeborg, Denmark, 8600
  • France
      • Amiens, France, 80030
      • Lille Cedex, France, 59037
      • Nancy, France, 54037
  • Germany
      • Berlin, Germany, 14165
    • Baden-Württemberg
      • Rheinfelden, Baden-Württemberg, Germany, 79618
    • Bayern
      • Fürth, Bayern, Germany, 90766
      • Garmisch-Partenkirchen, Bayern, Germany, 82467
    • Hessen
      • Frankfurt, Hessen, Germany, 60528
      • Frankfurt, Hessen, Germany, 65929
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
  • Israel
      • Haifa, Israel, 31096
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
      • Zerifin, Israel, 70300
  • Netherlands
      • Amersfoort, Netherlands, 3818 ES
      • Zwolle, Netherlands, 8025 AB
  • Norway
      • Notodden, Norway, NO-3675
      • Oslo, Norway, 0440
      • Rjukan, Norway, NO-3660
  • Poland
      • Bialystok, Poland, 15-276
      • Gdansk, Poland, 80-742
      • Krakow, Poland, 31-826
      • Lodz, Poland, 91-425
      • Lublin, Poland, 20-090
      • Lublin, Poland, 20-718
      • Warszawa, Poland, 00-909
  • Sweden
      • Göteborg, Sweden, 416 85
      • Jönköping, Sweden, 551 85
      • Kungälv, Sweden, 442 83
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male patients aged 18 years or above and postmenopausal female patients.
  • Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis).
  • Patients' written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.

Exclusion Criteria:

  • DVT or PE within the previous 6 months prior to study entry.
  • Myocardial infarction (MI) or cerebrovascular attack (CVA), TIA or ischaemic stroke within the last 6 months prior to study entry.
  • History of heparin-induced thrombocytopenia, allergy to heparins.
  • Intracerebral or intraocular bleeding within the last 6 months prior to study entry.
  • History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study.
  • History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug
  • Amputation of one leg.Related to current symptoms or findings
  • Heart insufficiency NYHA III-IV.
  • Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits).
  • Thrombocytopenia (platelets < 50.000/µl).
  • Macroscopic haematuria.
  • Allergy to contrast media.
  • Severe hypertension (SBP > 200mmHg, DBP > 100 mmHg).
  • Impaired liver function (transaminases > 2 x ULN).
  • Impaired renal function (serum creatinine > 1.5 x ULN).
  • Active malignant disease.
  • Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding.
  • Body weight < 45 kg.
  • Drug- or alcohol abuse.

  • Related to current treatment

    • Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium).
    • Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment
    • Treatment with heparins or Factor Xa Inhibitors other than study medication.
    • All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Arm 2
Drug: Enoxaparin
40 mg bid
Experimental: Arm 1
Drug: Rivaroxaban (BAY59-7939)
2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial

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
The primary efficacy endpoint is a composite endpoint of: - Any DVT (proximal and/or distal) and - Non fatal PE and - Death from all causes. The primary endpoint will be evaluated 5 - 9 days after surgery.
Time Frame: Assymptomatic DVT will be measured 5-9 days after surgery Symptomatc DVT , non-fatal PE and Death from all causes will be measured 41 days after surgery
Assymptomatic DVT will be measured 5-9 days after surgery Symptomatc DVT , non-fatal PE and Death from all causes will be measured 41 days after surgery

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
Incidence of DVTs (total, proximal, distal)
Time Frame: will be evaluated 5 - 9 days after surgery.
will be evaluated 5 - 9 days after surgery.
Incidence of symptomatic VTEs
Time Frame: 41 days after surgery
41 days after surgery
The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)
Time Frame: 41 days after surgery
41 days after surgery
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.
Time Frame: 41 days after surgery
41 days after surgery

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

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.
December 1, 2002

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.
November 1, 2003

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.
November 1, 2003

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 9, 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 9, 2009

First Posted (Estimate)

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 10, 2009

Study Record Updates

Last Update Posted (Estimate)

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.
December 17, 2014

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.
December 15, 2014

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.
December 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.
  • 10942

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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