Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251953
Status:
TERMINATED
Last Update Posted:
2009-04-22
First Post:
2005-11-09
Brief Title:
GALLANT 8 Tesaglitazar Add-on to Metformin
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 24-Week Randomised Double-Blind Parallel-Group Multi-Centre Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Metformin Alone
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The development program has been terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 24-week randomized double-blind parallel-group multi-center placebo-controlled study of tesaglitazar 05 mg and 1 mg given as add-on therapy to metformin in patients with type 2 diabetes not adequately controlled on optimized metformin treatment and on dietlifestyle advice during the titration and run-in period The study comprises a 2-week enrollment period 6 week placebo metformin titration period 2-week single-blind run-in period followed by a 24-week double blind treatment period and a 3-week follow-up period
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 No 2004-000348-25 | None | None | None |