Ignite Creation Date:
2025-12-17 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 6:07 AM
Study NCT ID:
NCT00737633
Status:
TERMINATED
Last Update Posted:
2012-09-10
First Post:
2008-08-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Sponsor:
VIVUS LLC
Organization:
Study Overview
Official Title:
An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: