check_circleStudy Completed

Deep vein thrombosis (DVT), Pulmonary embolism (PE)

Bayer Identifier:

11702

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2006-004495-13

EU CT Number:

Not Available
The EINSTEIN DVT study

Trial purpose

Primary Objective:
To evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA (VKA: either warfarin or acenocoumarol) in the treatment of subjects with acute symptomatic deep vein thrombosis without symptomatic pulmonary embolism for the prevention of recurrent venous thromboembolic events.

Secondary Objective:
The principal safety objective was the evaluation of major and clinically relevant non-major bleeding events.

Key Participants Requirements

Sex

All

Age

18 - 95 Years
  • Inclusion criteria
    - Confirmed acute symptomatic proximal DVT without symptomatic PE

Trial summary

Enrollment Goal
3449
Trial Dates
March 2007 - April 2010
Phase
Phase 3
Could I Receive a placebo
N/A
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Trial design

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis - The EINSTEIN DVT study
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
N/A

Additional Information

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