Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00557921
Status:
TERMINATED
Last Update Posted:
2009-01-28
First Post:
2007-11-12
Brief Title:
Clopidogrel and the Optimization of Gastrointestinal Events COGENT-1
Sponsor:
Cogentus Pharmaceuticals
Organization:
Cogentus Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Double-Dummy Parallel Group Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGENT-1
Brief Summary:
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 clopidogrel and omeprazole compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease in the setting of concomitant aspirin therapy
Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin clopidogrel and dual antiplatelet regimens
The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy typically in connection with peptic ulcer disease Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs Patients taking any two of these drugs clopidogrel aspirin andor non-aspirin NSAIDs are exposed to an even higher risk of bleeding and ulcer disease
Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product CGT-2168 which has the potential to significantly reduce this problem and increase patient safety CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant omeprazole in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events
Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin clopidogrel and dual antiplatelet regimens
The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy typically in connection with peptic ulcer disease Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs Patients taking any two of these drugs clopidogrel aspirin andor non-aspirin NSAIDs are exposed to an even higher risk of bleeding and ulcer disease
Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product CGT-2168 which has the potential to significantly reduce this problem and increase patient safety CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant omeprazole in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events
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 |
|---|---|---|---|
| EudraCT 2007-005891-15 | None | None | None |