Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT01021332
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Sponsor:
Astellas Pharma Europe B.V.
Organization:
Study Overview
Official Title:
An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Neptune II
Brief Summary:
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
Detailed Description:
This is an open-label extension study following the double blind 905-CL-055 study
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-001212-20 | EUDRACT_NUMBER | EudraCT | View |