Study Completed

Venous Thrombosis, Deep Vein Thrombosis

Bayer Identifier:

11223

ClinicalTrials.gov Identifier:

NCT00839163

EudraCT Number:

2004-001083-43

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal

613

Trial Dates

March 2004 - October 2005

Phase

Phase 2

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Allgemeines Krankenhaus der Stadt Wien Universitätskliniken	Wien, 1090, Austria
Completed	Flinders Medical Centre	Adelaide, 5042, Australia
Completed	Universitätsspital Zürich	Zürich, 8091, Switzerland
Completed	Ustredni vojenska nemocnice Praha	Praha 6, 169 02, Czech Republic
Completed	Dr Bugyi Istvan Hospital	Szentes, 6600, Hungary
Completed	Rambam Medical Center	Haifa, 31096, Israel
Completed	Hospital Nacional Cayetano Heredia	Lima, 31, Peru
Completed	Eastern Clinical Research Unit - Box Hill	Melbourne, 3128, Australia
Completed	Clínica Medellín	Medellín, Colombia
Completed	Brüderkrankenhaus St. Josef	Paderborn, 33098, Germany
Completed	A.O. di Reggio Emilia	Reggio Emilia, 42100, Italy
Completed	Hospital Nacional Arzobispo Loayza	Lima Cercado, LIMA 1, Peru
Completed	Hospital da Beneficiência Portuguesa	São Paulo, 01323-001, Brazil
Completed	Hospital Kladno	Kladno, 27259, Czech Republic
Completed	A.O. Osp Circolo e Fond.Macchi	Varese, 21100, Italy
Completed	CHUM - Hopital Hotel-Dieu	Montreal, H2W 1T8, Canada
Completed	Centro de Investigación Clínica FOQUS	Bogotá, Colombia
Completed	Klinikum Darmstadt	Darmstadt, 64276, Germany
Completed	Hospital Universitari Germans Trias i Pujol	Badalona, 08916, Spain
Completed	Policlinico Universitario Monteluce	Perugia, 06122, Italy
Completed	Haematology Service, Canterbury Health Laboratories	Christchurch, 8011, New Zealand
Completed	Centralny Szpital Kliniczny AM	Warszawa, 02-097, Poland
Completed	Universitetssjukhuset Lund	Lund, 221 85, Sweden
Completed	Hospital e Maternidade Sao Luiz	Sao Paulo, 04544 000, Brazil
Completed	Luzerner Kantonsspital	Luzern, 6000, Switzerland
Completed	Fakultni nemocnice u sv. Anny	Brno, 656 91, Czech Republic
Completed	Tel Aviv Sourasky Medical Center	Tel Aviv, 64239, Israel
Completed	Thrombosis Unit	Auckland, 1023, New Zealand
Completed	Sahlgrenska Universitetssjukhuset	Göteborg, 413 45, Sweden
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	St George Hospital	Sydney, 2217, Australia
Completed	Cardiodiagnostico S. A.	Barranquilla, Colombia
Completed	Mestska nemocnice Ostrava	Ostrava, 728 80, Czech Republic
Completed	Sapir Medical Center, Meir General Hospital	Kfar Saba, 44281, Israel
Completed	Stichting het van Weel Bethesda Ziekenhuis	DIRKSLAND, 3247 BW, Netherlands
Completed	Inselspital Bern	Bern, 3010, Switzerland
Completed	Hospital Clínico Universitario de Valencia	Valencia, 46010, Spain
Completed	Szent Imre Hospital	Budapest, 1115, Hungary
Completed	Hadassah University Hospital Ein Kerem	Jerusalem, 91120, Israel
Completed	A.O.U. Policlinico S.Orsola-Malpighi	Bologna, 40138, Italy
Completed	Länssjukhuset	Halmstad, 301 85, Sweden
Completed	Vergelegen Medi-Clinic	Somerset West, 7130, South Africa
Completed	Eastern Clinical Research Unit - Maroondah Hospital	Melbourne, 3135, Australia
Completed	St. Mary's Hospital Center	Montreal, H3T 1M5, Canada
Completed	Hospital General Universitario Gregorio Marañón	Madrid, 28007, Spain
Completed	Wojewodzki Szpital Specjalistyczny	Olsztyn, 10-560, Poland
Completed	Queen Elizabeth Hospital	Adelaide, 5011, Australia
Completed	Hamilton General Hospital	Hamilton, L8L 2X2, Canada
Completed	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Edith Wolfson Medical Center	Holon, 58100, Israel
Completed	Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis	DEN BOSCH, 5211 RB, Netherlands
Completed	Hospital Dos de Mayo	Lima, 01, Peru
Completed	Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ	Lublin, 20-718, Poland
Completed	SU/Östra	Göteborg, 416 85, Sweden
Completed	Wilhelminenspital der Stadt Wien	Wien, 1171, Austria
Completed	Royal Perth Hospital	Perth, 6000, Australia
Completed	Franziskus-Krankenhaus	Berlin, 10787, Germany
Completed	Hospital Josep Trueta	Girona, 17007, Spain
Completed	North Shore Hospital	Auckland, 0622, New Zealand
Completed	Samodzielny Szpital Publiczny	Bytom, 41-902, Poland
Completed	Länssjukhuset Ryhov	Jönköping, 551 85, Sweden
Completed	Pretoria Academic Hospital Ethics Committee	Pretoria, 0084, South Africa
Completed	Ottawa Health Research Institute	Ottawa, K1Y 4E9, Canada
Completed	Vseobecná fakultni nemocnice	Praha 2, 12808, Czech Republic
Completed	Fakultni nemocnice Královské Vinohrady	Praha 10, 10034, Czech Republic
Completed	Hospital Universitario de la Princesa	Madrid, 28006, Spain
Completed	A.O. di Padova	Padova, 35128, Italy
Completed	SP Centralny Szpital Kliniczny im. Gibinskiego	Katowice, 40-752, Poland
Completed	Unitas Hospital	Pretoria, 0157, South Africa
Completed	University of Pecs, Medical & Health Science Center	Pecs, 7624, Hungary
Completed	IRCCS Ist Clinico Humanitas	Rozzano, 20089, Italy
Completed	Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia	Poznan, 61-833, Poland
Completed	Tiervlei Trial Centre	Cape Town, 7531, South Africa
Completed	Evang. Krankenhaus Königin Elisabeth, Herzberge	Berlin, 10365, Germany
Completed	Wilgers Hospital	Pretoria, PRETORIA, South Africa
Completed	Medizinische Fakultät Carl Gustav Carus	Dresden, 01307, Germany
Completed	SP Szpital Kliniczny AM w Bialymstoku	Bialystok, 15-276, Poland
Completed	Vinzenz Pallotti Hospital	Bergisch Gladbach, 51429, Germany
Completed	Medisch Centrum Haaglanden, Locatie Antoniushove	LEIDSCHENDAM, 2262 BA, Netherlands
Completed	SRH Klinikum-Karlsbad-Langensteinbach gGmbH	Karlsbad, 76307, Germany
Completed	Medisch Spectrum Twente, Locatie Ariensplein	ENSCHEDE, 7511 JX, Netherlands
Completed	AZ Sint-Maarten	DUFFEL, 2570, Belgium
Completed	Universitätsspital Basel	Basel, 4031, Switzerland
Completed	Fakultni nemocnice Plzen	Plzen, 30599, Czech Republic
Completed	St. Josefskrankenhaus	Heidelberg, 69115, Germany
Completed	Clalit Health Services - Haemek Medical Center	Afula, 18101, Israel
Completed	AUSL Piacenza - Emilia Romagna	Piacenza, 29100, Italy
Completed	University of the Free State	Bloemfontein, 9300, South Africa
Completed	Klinikum Mannheim gGmbH	Mannheim, 68167, Germany
Completed	University of Debrecen Medical&Health Science Center	Debrecen, 4032, Hungary
Completed	The Barzilai Medical Center Ashkelon	Ashkelon, 78306, Israel
Completed	The Avenue Cardiovascular Centre	Melbourne, 3181, Australia
Completed	UZ Leuven Gasthuisberg	LEUVEN, 3000, Belgium
Completed	Humber River Regional Hospital	Toronto, M3N 1N1, Canada
Completed	Klinikum Innenstadt der Ludwigs-Maximilians-Universität	München, 80336, Germany
Completed	St. Paul's Hospital - Vancouver	Vancouver, V6Z 1Y6, Canada
Completed	Lakeridge Health-Oshawa	Oshawa, L1G 2B9, Canada
Completed	St. Joseph's Healthcare - Hamilton	Hamilton, L8N 4A6, Canada
Completed	St. Joseph's Health Centre	Sudbury, P3E 3B5, Canada
Completed	North Bay General Hospital	North Bay, P1B 5A4, Canada
Completed	Hospital Universitario de Canarias	La Laguna, 38320, Spain
Completed	Ikazia Ziekenhuis	ROTTERDAM, 3083 AN, Netherlands
Completed	A.O. Osp Niguarda Ca' Granda	Milano, 20162, Italy
Completed	Uniwersyteckie Centrum Kliniczne	Gdansk, 80-952, Poland
Completed	Hospital Sant Jaume de Olot	Olot, 17800, Spain
Completed	A.O. San Paolo Polo Universitario	Milano, 20142, Italy
Completed	Ziekenhuis Rijnstate	ARNHEM, 6815 AD, Netherlands
Completed	A.O.U. Policlinico Giaccone	Palermo, 90129, Italy
Completed	Medisch Centrum Haaglanden, Locatie Westeinde	DEN HAAG, 2512 VA, Netherlands
Completed	AH Research	Windsor, N8X 3V6, Canada

Primary Outcome

Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Time Frame:
21 days
Safety Issue:
No

Secondary Outcome

Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Time Frame:
Day 21
Safety Issue:
No
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Time Frame:
Day 84
Safety Issue:
No
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Time Frame:
Day 1-84
Safety Issue:
No
Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period
Time Frame:
Day 1-84
Safety Issue:
No
Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug
Time Frame:
Day 1-114
Safety Issue:
No

Trial design

ODIXa-DVTA prospective, randomized, multinational, multicenter, partially blinded, parallel-group, open-label active comparator controlled phase II dose finding and proof of principle trial.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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