Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT01655069
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2012-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Sponsor:
Astellas Pharma Europe B.V.
Organization:
Study Overview
Official Title:
An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)
Status:
COMPLETED
Status Verified Date:
2024-10
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:
LEOPARD
Brief Summary:
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
Detailed Description:
There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-002047-10 | EUDRACT_NUMBER | None | View |