Trial Condition(s):

Venous Thromboembolism

Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

Bayer Identifier:

11899

ClinicalTrials.gov Identifier:

NCT00439725

EudraCT Number:

2006-004494-96

Study Completed

Trial Purpose

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Inclusion Criteria
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Exclusion Criteria
- Legal lower age limitations (country specific)
 - Indication for VKA other than DVT and/or PE
 - Patients in whom anticoagulant treatment for their index PE or DVT should be continued
 - Childbearing potential without proper contraceptive measures,  pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy

Trial Summary

Enrollment Goal
1197
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Karlsbad, Germany, 76307

Status
Completed
 
Locations

Investigative Site

Mannheim, Germany, 68167

Status
Completed
 
Locations

Investigative Site

Augsburg, Germany, 86156

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Investigative Site

London, United Kingdom

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99204

Status
Completed
 
Locations

Investigative Site

Oklahoma City, United States, 73104

Status
Completed
 
Locations

Investigative Site

Albuquerque, United States, 87108

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69115

Status
Completed
 
Locations

Investigative Site

Paderborn, Germany, 33098

Status
Completed
 
Locations

Investigative Site

Magdeburg, Germany, 39112

Status
Completed
 
Locations

Investigative Site

München, Germany, 80331

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27401

Status
Completed
 
Locations

Investigative Site

LIMOGES, France, 87042

Status
Completed
 
Locations

Investigative Site

DIJON, France, 21000

Status
Completed
 
Locations

Investigative Site

COLOMBES, France, 92700

Status
Completed
 
Locations

Investigative Site

MONTPELLIER CEDEX, France, 34295

Status
Completed
 
Locations

Investigative Site

STRASBOURG CEDEX, France, 67091

Status
Completed
 
Locations

Investigative Site

AGEN CEDEX 9, France, 47923

Status
Completed
 
Locations

Investigative Site

AMIENS, France, 80000

Status
Completed
 
Locations

Investigative Site

Isleworth, United Kingdom, TW7 6AF

Status
Completed
 
Locations

Investigative Site

San Antonio, United States, 78229

Status
Completed
 
Locations

Investigative Site

Chapel Hill, United States, 27599-7035

Status
Completed
 
Locations

Investigative Site

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Investigative Site

Wroclaw, Poland, 50-326

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-066

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 01-138

Status
Completed
 
Locations

Investigative Site

Lodz, Poland, 90-153

Status
Completed
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Venezia, Italy, 30122

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27403

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21215-5271

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15224

Status
Completed
 
Locations

Investigative Site

SAINT ETIENNE, France, 42055

Status
Completed
 
Locations

Investigative Site

VERNON, France, 27200

Status
Completed
 
Locations

Investigative Site

Chieti, Italy, 66013

Status
Completed
 
Locations

Investigative Site

Parma, Italy, 43126

Status
Completed
 
Locations

Investigative Site

Xàtiva, Spain, 46800

Status
Completed
 
Locations

Investigative Site

Pamplona, Spain, 31008

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Investigative Site

BREST CEDEX, France, 29609

Status
Completed
 
Locations

Investigative Site

CLAMART, France, 92141

Status
Completed
 
Locations

Investigative Site

GRENOBLE, France, 38043

Status
Completed
 
Locations

Investigative Site

NANTES, France, 44000

Status
Completed
 
Locations

Investigative Site

ANGERS CEDEX 01, France, 49033

Status
Completed
 
Locations

Investigative Site

CLERMONT FERRAND, France, 63000

Status
Completed
 
Locations

Investigative Site

VANDOEUVRE LES NANCY, France, 54511

Status
Completed
 
Locations

Investigative Site

ARRAS, France, 62000

Status
Completed
 
Locations

Investigative Site

CASTELNAU LE LEZ, France, 34170

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Investigative Site

ARNHEM, Netherlands, 6815 AD

Status
Completed
 
Locations

Investigative Site

HOOFDDORP, Netherlands, 2134 TM

Status
Completed
 
Locations

Investigative Site

Borås, Sweden, 501 82

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Investigative Site

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Investigative Site

Västervik, Sweden, 593 81

Status
Completed
 
Locations

Investigative Site

Aarhus C, Denmark, 8000

Status
Completed
 
Locations

Investigative Site

Fredrikstad, Norway, 1603

Status
Completed
 
Locations

Investigative Site

Rud, Norway, 1309

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0407

Status
Completed
 
Locations

Investigative Site

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Investigative Site

Wroclaw, Poland, 51-124

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20142

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80131

Status
Completed
 
Locations

Investigative Site

Piacenza, Italy, 29121

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08025

Status
Completed
 
Locations

Investigative Site

Girona, Spain, 17007

Status
Completed
 
Locations

Investigative Site

Terrassa, Spain, 08221

Status
Completed
 
Locations

Investigative Site

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Investigative Site

Roodepoort, South Africa, 1724

Status
Completed
 
Locations

Investigative Site

Pretoria, South Africa, 0181

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2193

Status
Completed
 
Locations

Investigative Site

Ostrava-Poruba, Czech Republic, 708 52

Status
Completed
 
Locations

Investigative Site

Usti nad Lebem, Czech Republic, 401 13

Status
Completed
 
Locations

Investigative Site

Holon, Israel, 58100

Status
Completed
 
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

ZOTTEGEM, Belgium, 9620

Status
Completed
 
Locations

Investigative Site

GRONINGEN, Netherlands, 9713 GZ

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Investigative Site

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Investigative Site

Frederiksberg, Denmark, 2000F

Status
Completed
 
Locations

Investigative Site

Braedstrup, Denmark, 8740

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5042

Status
Completed
 
Locations

Investigative Site

Woolloongabba, Australia, 4102

Status
Completed
 
Locations

Investigative Site

Kogarah, Australia, 2217

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3135

Status
Completed
 
Locations

Investigative Site

Concord, Australia, 2139

Status
Completed
 
Locations

Investigative Site

Garran, Australia, 2605

Status
Completed
 
Locations

Investigative Site

Geelong, Australia, 3220

Status
Completed
 
Locations

Investigative Site

Gosford, Australia, 2250

Status
Completed
 
Locations

Investigative Site

Sydney, Australia, 2229

Status
Completed
 
Locations

Investigative Site

Box Hill, Australia, 3128

Status
Completed
 
Locations

Investigative Site

LISMORE, Australia, 2480

Status
Completed
 
Locations

Investigative Site

Brisbane, Australia, 4029

Status
Completed
 
Locations

Investigative Site

Salzburg, Austria, 5020

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2191

Status
Completed
 
Locations

Investigative Site

Worcester, South Africa, 6850

Status
Completed
 
Locations

Investigative Site

Pretoria, South Africa, 0157

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2157

Status
Completed
 
Locations

Investigative Site

Prague 5, Czech Republic, 150 00

Status
Completed
 
Locations

Investigative Site

Ostrava, Czech Republic, 728 80

Status
Completed
 
Locations

Investigative Site

Praha 1, Czech Republic, 110 00

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

Kladno, Czech Republic, 27259

Status
Completed
 
Locations

Investigative Site

Afula, Israel, 1834111

Status
Completed
 
Locations

Investigative Site

Kecskemet, Hungary, 6000

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Kistarcsa, Hungary, 2143

Status
Completed
 
Locations

Investigative Site

Szentes, Hungary, 6600

Status
Completed
 
Locations

Investigative Site

Curitiba, Brazil, 80050-350

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 01323-001

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 04039-004

Status
Completed
 
Locations

Investigative Site

Uberaba, Brazil, 38010 380

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

shanghai, China, 200001

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Ashkelon, Israel, 7827804

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Status
Terminated
 
Locations

Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3436212

Status
Completed
 
Locations

Investigative Site

St Leonards, Australia, 2065

Status
Completed
 
Locations

Investigative Site

Redcliffe, Australia, 4020

Status
Completed
 
Locations

Investigative Site

Clayton, Australia, 3168

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5011

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3181

Status
Completed
 
Locations

Investigative Site

Perth, Australia, 6000

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1140

Status
Completed
 
Locations

Investigative Site

Feldkirch, Austria, 6807

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100029

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100730

Status
Completed
 
Locations

Investigative Site

Pune, India, 411001

Status
Completed
 
Locations

Investigative Site

Miskolc, Hungary, 3526

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1115

Status
Completed
 
Locations

Investigative Site

Szombathely, Hungary, 9700

Status
Completed
 
Locations

Investigative Site

Rio de Janeiro, Brazil, 20551-030

Status
Completed
 
Locations

Investigative Site

Londrina, Brazil, 86038440

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

shenyang, China, 110016

Status
Completed
 
Locations

Investigative Site

Suzhou, China, 215004

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200433

Status
Completed
 
Locations

Investigative Site

New Delhi, India, 110060

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, 0850

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 169608

Status
Completed
 
Locations

Investigative Site

Christchurch, New Zealand, 8011

Status
Completed
 
Locations

Investigative Site

Auckland, New Zealand, 1023

Status
Completed
 
Locations

Investigative Site

Wellington South, New Zealand, 6021

Status
Completed
 
Locations

Investigative Site

Medan, Indonesia, 20152

Status
Completed
 
Locations

Investigative Site

Luzern, Switzerland, 6000

Status
Completed
 
Locations

Investigative Site

Genéve 14, Switzerland, 1211

Status
Completed
 
Locations

Investigative Site

Hyderabad, India, 500082

Status
Completed
 
Locations

Investigative Site

Kochi, India, 682026

Status
Completed
 
Locations

Investigative Site

Selangor, Malaysia, 68000

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, 1102

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 308433

Status
Completed
 
Locations

Investigative Site

Auckland, New Zealand, 0622

Status
Completed
 
Locations

Investigative Site

Palmerston North, New Zealand, 4414

Status
Completed
 
Locations

Investigative Site

Pathumwan, Bangkok, Thailand, 10330

Status
Completed
 
Locations

Investigative Site

Bangkok, Thailand, 10400

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 

Trial Design