Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347061
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2006-06-30
Brief Title:
Long Term Safety of SL770499-10 Alfuzosin in Patients With BPH
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Long-term Safety and Efficacy of SL770499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia BPHA Multicenter 52-week Open Label Uncontrolled Study
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:
Primary
To assess the safety of SL770499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH
Secondary
To provide the information on the efficacy of SL770499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH
To document the plasma concentration of SL770499-10 after repeated administration of SL770499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH
To assess the safety of SL770499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH
Secondary
To provide the information on the efficacy of SL770499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH
To document the plasma concentration of SL770499-10 after repeated administration of SL770499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH
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