Ignite Creation Date:
2025-12-17 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 12:07 AM
Study NCT ID:
NCT00745251
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2008-08-31
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
Sponsor:
VIVUS LLC
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.
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?: