Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399464
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2006-11-13
Brief Title:
Efficacy and Safety of SL770499-10 Alfuzosin Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy and Safety of SL770499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 02mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia BPH
Status:
COMPLETED
Status Verified Date:
2009-10
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:
None
Brief Summary:
The primary objective of the study is to demonstrate the superiority of SL770499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH
The secondary objective is to assess the safety of SL770499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride
The secondary objective is to assess the safety of SL770499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride
Detailed Description:
None
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