Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491525
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-07-28
Brief Title:
A Study of Vibegron in Pediatric Participants 2 Years to Less Than 18 Years of Age With NDO and on CIC
Sponsor:
Urovant Sciences GmbH
Organization:
Urovant Sciences GmbH
Study Overview
Official Title:
A Phase 23 Open-label Baseline-controlled Multicenter Long-term Study to Evaluate the Safety Efficacy and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to 18 Years of Age With Neurogenic Detrusor Overactivity NDO on Clean Intermittent Catheterization CIC
Status:
RECRUITING
Status Verified Date:
2024-07
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:
KANGUROO
Brief Summary:
The purpose of this study is to evaluate the safety efficacy and PK of vibegron in pediatric participants with NDO who are regularly using CIC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None