Status:
COMPLETED
ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial
Lead Sponsor:
Bayer
Conditions:
Thromboembolism
Prevention
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, significa...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT00839826
Start Date
December 1 2002
End Date
November 1 2003
Last Update
December 17 2014
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Wiener Neustadt, Lower Austria, Austria, 2700
2
Linz, Upper Austria, Austria, 4010
3
Vienna, Vienna, Austria, 1220
4
Baudour, Belgium, 7331