Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261352
Status:
TERMINATED
Last Update Posted:
2009-04-22
First Post:
2005-12-01
Brief Title:
GALLANT 14 Tesaglitazar vs Metformin and Fenofibrate
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 24-Week Randomised Double-Blind Parallel-Group Multi-Centre Active-Controlled Metformin or Metformin Combined With Fenofibrate Study to Evaluate the Lipid Metabolic Effects Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
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 study to determine the lipid metabolic effects safety and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol HDL-C Improvement in dyslipidemia will be evaluated The study comprises a 2-week enrollment period 6-week run-in and a 24-week randomized double blind parallel group multi-center active controlled metformin with or without fenofibrate treatment period and a 3-week follow-up From visit 2 run-in all patients will receive a standardized dose of statin rosuvastatin
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 2004-02550-56 | None | None | None |