Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440193
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2007-02-23
Brief Title:
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This is a multicenter randomized open-label assessor-blind event-driven non-inferiority program for efficacy with a study treatment duration of 3 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE Einstein-DVT
Detailed Description:
Within the US Johnson Johnson Pharmaceutical Research Development LLC is sponsor
The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication regardless of the actual duration of study drug administration Participants who did not complete the treatment period also entered the observational period It was also possible that participants did not enter the observational period eg due to withdrawal of consent or termination of study participation Participants who were transferring from study 11702 DVT NCT00440193 to the extension study 11899 NCT00439725 did not enter the observational period
The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication regardless of the actual duration of study drug administration Participants who did not complete the treatment period also entered the observational period It was also possible that participants did not enter the observational period eg due to withdrawal of consent or termination of study participation Participants who were transferring from study 11702 DVT NCT00440193 to the extension study 11899 NCT00439725 did not enter the observational period
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 |
|---|---|---|---|
| 11702b | OTHER | Company internal | None |
| 2006-004495-13 | EUDRACT_NUMBER | None | None |