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Venous ThromboembolismPhase 2ODIXa-HIP2NCT00398905

Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 61 sites in 13 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

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
726 participants
Where
61 sitesin 13 countries
Study dates
Jan 2004to Sep 2004
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

  • 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

Who cannot join

  • Any VTE prior to randomization
  • Myocardial infarction (MI) or TIA or ischaemic stroke within the last 6 months prior to randomisation
  • History of heparin-induced thrombocytopenia, allergy to heparins
  • Intracerebral or intraocular bleeding within the last 6 months prior to randomisation
  • 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 (e.g. severe active inflammatory bowel disease, short gut syndrome)
Show all 27Show fewer
  • Amputation of one leg
  • Heart insufficiency NYHA III-IV
  • Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits) including patients with acquired or congenital thrombopathy
  • Thrombocytopenia (platelets < 100.000/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 or creatinine clearance < 30 ml/min)
  • 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
  • Patients who cannot stop therapy ( in the opinion of the investigator/ physician) with anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) and fibrinolytic therapy should be excluded from the study
  • Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment. Patients not able to stop ASA therapy will be excluded
  • All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed)
  • Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole) and other strong CYP3A4 inhibitors e.g. HIV-protease inhibitors. Azole compounds and other strong CYP3A4 inhibitors
  • Therapy with another investigational product within 30 days prior start of study
  • Planned intermittent pneumatic compression during active treatment period
  • Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed)
  • Concomitant participation in another trial or study

Trial locations and contacts

61 sites in 13 countries.

61 sites in 13 countries

Germany11 sites

  • Study site

    Berlin, State of Berlin, 14165

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Frankfurt am Main, Hesse, 60528

  • Study site

    Frankfurt am Main, Hesse, 65929

  • Study site

    Fürth, Bavaria, 90766

  • Study site

    Garmisch-Partenkirchen, Bavaria, 82467

  • Study site

    Marburg, Hesse, 35043

  • Study site

    Rheinfelden, Baden-Wurttemberg, 79618

  • Study site

    Sommerfeld, Brandenburg, 16766

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Italy7 sites

  • Study site

    Gubbio, Perugia, 06024

  • Study site

    Milan, 20132

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06122

  • Study site

    Reggio Emilia, 42100

  • Study site

    Rozzano, Milano, 20089

  • Study site

    Varese, 21100

Other trials in Italy

Poland7 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Gdansk, 80-742

  • Study site

    Krakow, 31-826

  • Study site

    Lodz, 91-425

  • Study site

    Lublin, 20-090

  • Study site

    Lublin, 20-718

  • Study site

    Warsaw, 00-909

Other trials in Poland

Belgium5 sites

  • Study site

    Baudour, 7331

  • Study site

    Bruxelles - Brussel, 1020

  • Study site

    Genk, 3600

  • Study site

    Huy, 4500

  • Study site

    Sint-Truiden, 3800

Other trials in Belgium

Norway5 sites

  • Study site

    Bodø, NO-8005

  • Study site

    Drammen, NO-3019

  • Study site

    Notodden, NO-3675

  • Study site

    Oslo, 0440

  • Study site

    Rjukan, NO-3660

Other trials in Norway

Denmark4 sites

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hørsholm, DK-2970

  • Study site

    Silkeborg, 8600

Other trials in Denmark

Israel4 sites

  • Study site

    Haifa, 31096

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer, 52621

  • Study site

    Tsrifin, 70300

Other trials in Israel

Spain4 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Valencia, Valencia, 46010

Other trials in Spain

Sweden4 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Halmstad, 301 85

  • Study site

    Jönköping, 551 85

  • Study site

    Kungälv, 442 83

Other trials in Sweden

Austria3 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, State of Vienna, 1220

  • Study site

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

France3 sites

  • Study site

    Amiens, 80030

  • Study site

    Lille, 59037

  • Study site

    Poitiers, 86000

Other trials in France

Netherlands3 sites

  • Study site

    Hilversum, 1213 XZ

  • Study site

    Nijmegen, 6522 JV

  • Study site

    Sittard, 6131 BK

Other trials in Netherlands

United Kingdom1 site

  • Study site

    London, Greater London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin
Keywords
Prevention of venous thromboembolism
Medical subject headings
Venous Thromboembolism

What participants receive

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

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    2,5 mg twice daily (5 mg total daily dose)

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    5 mg twice daily (10 mg total daily dose)

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    10 mg twice daily (20 mg total daily dose)

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    20 mg twice daily (40 mg total daily dose)

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    30 mg twice daily (60 mg total daily dose)

  • EnoxaparinDrug

    40 mg once daily (40 mg total daily dose)

Study groups in NCT00398905
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 4ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 5ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 6Active comparatorNot described
Receives: Drug: Enoxaparin

What is being measured

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

  1. Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes

    Measured: 5-9 days after surgery

Secondary outcomes (4)

  1. Incidence of DVTs (total, proximal, distal)

    Measured: 5-9 days after surgery

  2. Incidence of symptomatic Venous Thrombo Embolisms (VTEs)

    Measured: 5-9 days after surgery

  3. Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug

    Measured: 40 days

  4. Healthcare Resource Utilisation Questionnaire

    Measured: 9 days and 40 days after surgery

Timeline

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

  1. First posted14 Nov 2006 (estimated)
  2. Study startJan 2004
  3. Study completionSep 2004

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
726 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398905
Sponsor's protocol ID
10944
Acronym
ODIXa-HIP2
Status last verified
May 2009
First submitted
7 Nov 2006
Last updated
8 May 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 61 sites in 13 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 3 inclusion and 27 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 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Germany, Italy, Poland, Belgium, Norway and 8 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?

Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes (time frame: 5-9 days after surgery). 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 NCT00398905.

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 8 May 2009; AzTrials last refreshed its copy on 7 Nov 2026.

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