At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,055 enrolled
Drug / intervention
Enoxaparin +1 moredrug
Likely dose
Enoxaparin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
In Brief
A Phase 3 clinical trial evaluating Enoxaparin and Dabigatran etexilate for Venous Thromboembolism. Completed, enrolled 2,055 participants across 108 sites in 19 countries.
Detailed Summary
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, Germany, Hungary, India, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedApr 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedApr 14, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.2 years ago
Interventions
Enoxaparindrug
40 mg once daily
Dabigatran etexilatedrug
220 mg once daily