Trial Condition(s):

Venous thrombosis, Deep Vein Thrombosis

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients with Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Bayer Identifier:

11223

ClinicalTrials.gov Identifier:

NCT00839163

EudraCT Number:

2004-001083-43

Study Completed

Trial Purpose

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

Inclusion Criteria
- Patients with acute symptomatic proximal deep vein thrombosis
Exclusion Criteria
- Contraindication to comparator drugs
- Symptomatic Pulmonary embolism
- Conditions with increased bleeding risk
- Unstable patients with reduced life expectancy
- Severe renal impairment
- Impaired liver function
- Strong CYP 3A4 inhibitors
- Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
- NSAIDs with half-life > 17 hours

Trial Summary

Enrollment Goal
613
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

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Flinders Medical Centre

Adelaide, Australia, 5042

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Ustredni vojenska nemocnice Praha

Praha 6, Czech Republic, 169 02

Status
Completed
 
Locations

Dr Bugyi Istvan Hospital

Szentes, Hungary, 6600

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Hospital Nacional Cayetano Heredia

Lima, Peru, 31

Status
Completed
 
Locations

Eastern Clinical Research Unit - Box Hill

Melbourne, Australia, 3128

Status
Completed
 
Locations

Clínica Medellín

Medellín, Colombia

Status
Completed
 
Locations

Brüderkrankenhaus St. Josef

Paderborn, Germany, 33098

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Hospital Nacional Arzobispo Loayza

Lima Cercado, Peru, LIMA 1

Status
Completed
 
Locations

Hospital da Beneficiência Portuguesa

São Paulo, Brazil, 01323-001

Status
Completed
 
Locations

Hospital Kladno

Kladno, Czech Republic, 27259

Status
Completed
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Completed
 
Locations

CHUM - Hopital Hotel-Dieu

Montreal, Canada, H2W 1T8

Status
Completed
 
Locations

Centro de Investigación Clínica FOQUS

Bogotá, Colombia

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64276

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Policlinico Universitario Monteluce

Perugia, Italy, 06122

Status
Completed
 
Locations

Haematology Service, Canterbury Health Laboratories

Christchurch, New Zealand, 8011

Status
Completed
 
Locations

Centralny Szpital Kliniczny AM

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Universitetssjukhuset Lund

Lund, Sweden, 221 85

Status
Completed
 
Locations

Hospital e Maternidade Sao Luiz

Sao Paulo, Brazil, 04544 000

Status
Completed
 
Locations

Luzerner Kantonsspital

Luzern, Switzerland, 6000

Status
Completed
 
Locations

Fakultni nemocnice u sv. Anny

Brno, Czech Republic, 656 91

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Thrombosis Unit

Auckland, New Zealand, 1023

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

St George Hospital

Sydney, Australia, 2217

Status
Completed
 
Locations

Cardiodiagnostico S. A.

Barranquilla, Colombia

Status
Completed
 
Locations

Mestska nemocnice Ostrava

Ostrava, Czech Republic, 728 80

Status
Completed
 
Locations

Sapir Medical Center, Meir General Hospital

Kfar Saba, Israel, 44281

Status
Completed
 
Locations

Stichting het van Weel Bethesda Ziekenhuis

DIRKSLAND, Netherlands, 3247 BW

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Szent Imre Hospital

Budapest, Hungary, 1115

Status
Completed
 
Locations

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Status
Completed
 
Locations

A.O.U. Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

Länssjukhuset

Halmstad, Sweden, 301 85

Status
Completed
 
Locations

Vergelegen Medi-Clinic

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Eastern Clinical Research Unit - Maroondah Hospital

Melbourne, Australia, 3135

Status
Completed
 
Locations

St. Mary's Hospital Center

Montreal, Canada, H3T 1M5

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny

Olsztyn, Poland, 10-560

Status
Completed
 
Locations

Queen Elizabeth Hospital

Adelaide, Australia, 5011

Status
Completed
 
Locations

Hamilton General Hospital

Hamilton, Canada, L8L 2X2

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Completed
 
Locations

Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis

DEN BOSCH, Netherlands, 5211 RB

Status
Completed
 
Locations

Hospital Dos de Mayo

Lima, Peru, 01

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Wilhelminenspital der Stadt Wien

Wien, Austria, 1171

Status
Completed
 
Locations

Royal Perth Hospital

Perth, Australia, 6000

Status
Completed
 
Locations

Franziskus-Krankenhaus

Berlin, Germany, 10787

Status
Completed
 
Locations

Hospital Josep Trueta

Girona, Spain, 17007

Status
Completed
 
Locations

North Shore Hospital

Auckland, New Zealand, 0622

Status
Completed
 
Locations

Samodzielny Szpital Publiczny

Bytom, Poland, 41-902

Status
Completed
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Pretoria Academic Hospital Ethics Committee

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Ottawa Health Research Institute

Ottawa, Canada, K1Y 4E9

Status
Completed
 
Locations

Vseobecná fakultni nemocnice

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Fakultni nemocnice Královské Vinohrady

Praha 10, Czech Republic, 10034

Status
Completed
 
Locations

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

SP Centralny Szpital Kliniczny im. Gibinskiego

Katowice, Poland, 40-752

Status
Completed
 
Locations

Unitas Hospital

Pretoria, South Africa, 0157

Status
Completed
 
Locations

University of Pecs, Medical & Health Science Center

Pecs, Hungary, 7624

Status
Completed
 
Locations

IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia

Poznan, Poland, 61-833

Status
Completed
 
Locations

Tiervlei Trial Centre

Cape Town, South Africa, 7531

Status
Completed
 
Locations

Evang. Krankenhaus Königin Elisabeth, Herzberge

Berlin, Germany, 10365

Status
Completed
 
Locations

Wilgers Hospital

Pretoria, South Africa, PRETORIA

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

SP Szpital Kliniczny AM w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Vinzenz Pallotti Hospital

Bergisch Gladbach, Germany, 51429

Status
Completed
 
Locations

Medisch Centrum Haaglanden, Locatie Antoniushove

LEIDSCHENDAM, Netherlands, 2262 BA

Status
Completed
 
Locations

SRH Klinikum-Karlsbad-Langensteinbach gGmbH

Karlsbad, Germany, 76307

Status
Completed
 
Locations

Medisch Spectrum Twente, Locatie Ariensplein

ENSCHEDE, Netherlands, 7511 JX

Status
Completed
 
Locations

AZ Sint-Maarten

DUFFEL, Belgium, 2570

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Fakultni nemocnice Plzen

Plzen, Czech Republic, 30599

Status
Completed
 
Locations

St. Josefskrankenhaus

Heidelberg, Germany, 69115

Status
Completed
 
Locations

Clalit Health Services - Haemek Medical Center

Afula, Israel, 18101

Status
Completed
 
Locations

AUSL Piacenza - Emilia Romagna

Piacenza, Italy, 29100

Status
Completed
 
Locations

University of the Free State

Bloemfontein, South Africa, 9300

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Completed
 
Locations

The Barzilai Medical Center Ashkelon

Ashkelon, Israel, 78306

Status
Completed
 
Locations

The Avenue Cardiovascular Centre

Melbourne, Australia, 3181

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Humber River Regional Hospital

Toronto, Canada, M3N 1N1

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

St. Paul's Hospital - Vancouver

Vancouver, Canada, V6Z 1Y6

Status
Completed
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

St. Joseph's Healthcare - Hamilton

Hamilton, Canada, L8N 4A6

Status
Completed
 
Locations

St. Joseph's Health Centre

Sudbury, Canada, P3E 3B5

Status
Completed
 
Locations

North Bay General Hospital

North Bay, Canada, P1B 5A4

Status
Completed
 
Locations

Hospital Universitario de Canarias

La Laguna, Spain, 38320

Status
Completed
 
Locations

Ikazia Ziekenhuis

ROTTERDAM, Netherlands, 3083 AN

Status
Completed
 
Locations

A.O. Osp Niguarda Ca' Granda

Milano, Italy, 20162

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Hospital Sant Jaume de Olot

Olot, Spain, 17800

Status
Completed
 
Locations

A.O. San Paolo Polo Universitario

Milano, Italy, 20142

Status
Completed
 
Locations

Ziekenhuis Rijnstate

ARNHEM, Netherlands, 6815 AD

Status
Completed
 
Locations

A.O.U. Policlinico Giaccone

Palermo, Italy, 90129

Status
Completed
 
Locations

Medisch Centrum Haaglanden, Locatie Westeinde

DEN HAAG, Netherlands, 2512 VA

Status
Completed
 
Locations

AH Research

Windsor, Canada, N8X 3V6

Status
Completed
 

Trial Design