Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510406
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2007-07-31
Brief Title:
A Study With Combination Treatment Tamsulosin Hydrochloride and Solifenacin Succinate in Male Patients With LUTSBPH
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Placebo Controlled Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms LUTS Associated With Benign Prostatic Hyperplasia BPH
Status:
COMPLETED
Status Verified Date:
2014-08
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:
SATURN
Brief Summary:
The study will examine the efficacysafety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH
Detailed Description:
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride solifenacin succinate
The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy
Other comparisons will be
Placebo and combination treatment Solifenacin monotherapy and combination treatment
The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy
Other comparisons will be
Placebo and combination treatment Solifenacin monotherapy and combination treatment
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 |
|---|---|---|---|
| EudraCT number 2006-002072-18 | None | None | None |