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Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement (ODIXa-HIP2)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00398905
First received: November 7, 2006
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Incidence of DVTs (total, proximal, distal) [ Time Frame: 5-9 days after surgery ]
  • Incidence of symptomatic Venous Thrombo Embolisms (VTEs) [ Time Frame: 5-9 days after surgery ]
  • Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug [ Time Frame: 40 days ]
  • Healthcare Resource Utilisation Questionnaire [ Time Frame: 9 days and 40 days after surgery ]

Enrollment: 726
Study Start Date: January 2004
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
2,5 mg twice daily (5 mg total daily dose)
Experimental: Arm 2 Drug: Rivaroxaban (Xarelto, BAY59-7939)
5 mg twice daily (10 mg total daily dose)
Experimental: Arm 3 Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg twice daily (20 mg total daily dose)
Experimental: Arm 4 Drug: Rivaroxaban (Xarelto, BAY59-7939)
20 mg twice daily (40 mg total daily dose)
Experimental: Arm 5 Drug: Rivaroxaban (Xarelto, BAY59-7939)
30 mg twice daily (60 mg total daily dose)
Active Comparator: Arm 6 Drug: Enoxaparin
40 mg once daily (40 mg total daily dose)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398905

  Show 61 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00398905     History of Changes
Other Study ID Numbers: 10944
Study First Received: November 7, 2006
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Prevention of venous thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014