Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168818
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2005-09-12
Brief Title:
Dabigatran Etexilate in Extended Venous Thromboembolism VTE Prevention After Hip Replacement Surgery
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase III Randomised Parallel Group Double-blind Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules 150 or 220 mg Once Daily Starting With Half Dose 75 or 110 mg on the Day of Surgery Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery RE-NOVATE Extended Thromboembolism Prevention After Hip Surgery
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate compared to a standard subcutaneous regimen of enoxaparin in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-001988-21 | EUDRACT_NUMBER | EudraCT | None |