Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291330
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2006-02-13
Brief Title:
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase III Randomised Double Blind Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin INR 20-30 for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism VTE Following Initial Treatment 5-10 Days With a Parenteral Anticoagulant Approved for This Indication
Status:
COMPLETED
Status Verified Date:
2014-04
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:
RE-COVER I
Brief Summary:
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed pro re nata - prn to maintain an International Normalised Ratio INR of 20-30 for 6 month treatment of acute symptomatic venous thromboembolism VTE following initial treatment 5-10 days with a parenteral anticoagulant approved for this indication This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE After achieving non-inferiority this trial also aims to establish superiority by means of hierarchical tests of dabigatran over warfarin
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 |
|---|---|---|---|
| 2005-001999-12 | EUDRACT_NUMBER | EudraCT | None |