Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214591
Status:
TERMINATED
Last Update Posted:
2010-11-19
First Post:
2005-09-20
Brief Title:
GALLANT 5 Tesaglitazar Versus Metformin
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 52-wk Randomised Double-Blind Parallel-Group Multi-Centre Active-Controlled Metformin Study to Evaluate the Efficacy Safety Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
Status:
TERMINATED
Status Verified Date:
2010-11
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 52-week randomized double-blind parallel-group multi-center active-controlled metformin study of tesaglitazar in patients with type 2 diabetes not adequately controlled on diet and lifestyle advice alone during the run-in period The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks
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