Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02751931
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2016-04-22
Brief Title:
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
Sponsor:
Astellas Pharma Europe BV
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
An Open-label Baseline-controlled Multicenter Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity NDO on Clean Intermittent Catheterization CIC
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Crocodile
Brief Summary:
The objective of the study was to evaluate the efficacy safety tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population
Detailed Description:
This was a phase 3 open-label baseline-controlled multicenter study The study consisted of 3 periods Pretreatment period for a maximum of 28 days before baseline including screening washout if applicable and baseline
Efficacy treatment period beginning the day after baseline and continuing to week 24 Long-term safety period beginning after week 24 and continuing to week 52 end of study EOS or to the end of treatment EOT
Efficacy treatment period beginning the day after baseline and continuing to week 24 Long-term safety period beginning after week 24 and continuing to week 52 end of study EOS or to the end of treatment EOT
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 |
|---|---|---|---|
| 2015-002876-25 | EUDRACT_NUMBER | None | None |