Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05215418
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2022-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Sponsor:
VIVUS LLC
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects
Status:
COMPLETED
Status Verified Date:
2024-06
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 study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: