Trial Condition(s):

Thromboembolism, Prevention

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

Bayer Identifier:

10942

ClinicalTrials.gov Identifier:

NCT00839826

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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).

Trial Summary

Enrollment Goal
641
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Städtische Kliniken Frankfurt am Main / Hoechst

Frankfurt, Germany, 65929

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Isala Klinieken, Locatie Sophia

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

Hopital Roger Salengro - Lille

LILLE CEDEX, France, 59037

Status
Completed
 
Locations

Meander Medisch Centrum/Locatie De Lichtenberg

AMERSFOORT, Netherlands, 3818 ES

Status
Completed
 
Locations

Notodden sykehus

Notodden, Norway, NO-3675

Status
Completed
 
Locations

Donauspital im SMZ-Ost der Stadt Wien

Wien, Austria, 1220

Status
Completed
 
Locations

UZ Brussel

BRUXELLES, Belgium, 1090

Status
Completed
 
Locations

Herlev Hospital

Herlev, Denmark, 2730

Status
Completed
 
Locations

Lovisenberg Diakonale sykehus

Oslo, Norway, 0440

Status
Completed
 
Locations

SP Szpital Kliniczny AM w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Gentofte Hospital

Hellerup, Denmark, 2900

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. Rydygiera

Krakow, Poland, 31-826

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Kungälvs Sjukhus

Kungälv, Sweden, 442 83

Status
Completed
 
Locations

Allgem. öffentl. Krankenhaus Wiener Neustadt

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

RHMS Site Louis Caty

BAUDOUR, Belgium, 7331

Status
Completed
 
Locations

Nordsjællands Hospital - Hørsholm

Hørsholm, Denmark, DK-2970

Status
Completed
 
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Helse Blefjell Rjukan sykehus

Rjukan, Norway, NO-3660

Status
Active, not recruiting
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria, 4010

Status
Completed
 
Locations

Orthopädische Universitätsklinik - Friedrichsheim

Frankfurt, Germany, 60528

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Hôpital Nord - Amiens

AMIENS, France, 80030

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Hopital Central - Nancy

NANCY, France, 54037

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

Status
Completed
 
Locations

Klinikum Fürth

Fürth, Germany, 90766

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Kreiskrankenhaus Rheinfelden

Rheinfelden, Germany, 79618

Status
Completed
 
Locations

CHR de Huy

HUY, Belgium, 4500

Status
Completed
 
Locations

Uniwersytet Medyczny

Lodz, Poland, 91-425

Status
Completed
 
Locations

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany, 82467

Status
Completed
 
Locations

Szpital Kliniczny nr 3

Gdansk, Poland, 80-742

Status
Completed
 
Locations

Helios Klinikum Emil von Behring

Berlin, Germany, 14165

Status
Completed
 

Trial Design