Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02524210
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2015-08-13
Brief Title:
Effect of Inhibitors of the Proton Pump on Intestinal Transporters
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study
Status:
COMPLETED
Status Verified Date:
2016-01
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:
BIPP
Brief Summary:
Dabigatran etexilate is a novel oral anticoagulant It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation However it increases the risk of gastrointestinal bleeding compared to standard treatment AVK 3 In these circumstances the risk benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump IPP
Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP omeprazole rabeprazole with dabigatran in healthy subjects
Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP omeprazole rabeprazole with dabigatran in healthy subjects
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 |
|---|---|---|---|
| 2013-004932-31 | EUDRACT_NUMBER | None | None |
| 140096A-21 | OTHER | ANSM | None |