A phase III randomised, parallel group, double-blind, active controlledstudy to investigate the efficacy and safety of oral 220 mg dabigatranetexilate (110 mg on the day of surgery followed by 220 mg once daily)compared to subcutaneous 40 mg enoxaparin once daily for 28-35 daysin prevention of venous thromboembolism in patients followingprimary elective total hip arthroplasty. (RE-NOVATE II) - RE-NOVATE II

• Conditions: Primary VTE prevention in patients following total hip replacement surgery; MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis

• Registration Number: EUCTR2007-002630-11-FI
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & CoKG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1920

Inclusion Criteria

Patients scheduled to undergo primary, unilateral, elective total hip replacement.
Male or female 18 years of age or older.
Patients giving written informed consent for study participation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of bleeding diathesis.
Ongoing treatment for VTE.
Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding).
Liver disease expected to have any potential impact on survival.
Known severe renal insufficiency (CrCl <30 ml/min).
Pre-menopausal women who:
a.Are pregnant.
b.Are nursing.
c.Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery. ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is the composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.