Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168805
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2005-09-12
Brief Title:
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily od Versus vs Enoxaparin 40mg od for Prevention of Thrombosis After Knee Surgery
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
RE-MODEL Thromboembolism Prevention After Knee Surgery Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules 150 or 220 mg Once Daily Starting With a Half Dose ie75 or 110 mg on the Day of Surgery Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days
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:
A phase III randomised parallel-group double-blind active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s 150 or 220 mg once daily starting with a half dose ie75 or 110 mg on the day of surgery comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery RE-MODEL Thromboembolism prevention after knee 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 |
|---|---|---|---|
| 2004-001317-34 | EUDRACT_NUMBER | EudraCT | None |