Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
NCT00571649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8101
Last updated 2016-09-15
Summary
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
- DRUG
-
Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
- DRUG
-
Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days
- DRUG
-
Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-11-30
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Croatia
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hong Kong
- Hungary
- India
- Indonesia
- Israel
- Italy
- Japan
- Latvia
- Lithuania
- Luxembourg
- Malaysia
- Mexico
- Netherlands
- New Zealand
- Norway
- Pakistan
- Peru
- Poland
- Portugal
- Romania
- Russia
- Singapore
- Slovakia
- Slovenia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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