Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220389
Status:
COMPLETED
Last Update Posted:
2008-10-16
First Post:
2005-09-14
Brief Title:
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder a Double-Blind Phase Followed by an Open-Label Extension Phase
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive BladderOAB a Double-Blind Phase Followed by an Open-Label Extension Phase
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This extension trial of SP668 consists of two phases double-blind treatment and open-label extension The trial provides subjects the option of long-term treatment with sustained release SR fesoterodine SPM 907 and to assess long-term subject safety tolerability and efficacy
Double-Blind Subjects remained on either fesoterodine 4mg 8mg or 12mg depending on their dose assignment in SP668 Previous SP668 placebo subjects received fesoterodine 4mg
Open-Label Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg
The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events residual urinary volumes laboratory parameters changes in ECG physical and urological examinations and subjects assessment of treatment tolerance
Secondary efficacy variables include various parameters derived from micturition diaries count of subjects and their dose choice throughout the trial and subjects assessment of treatment efficacy
Double-Blind Subjects remained on either fesoterodine 4mg 8mg or 12mg depending on their dose assignment in SP668 Previous SP668 placebo subjects received fesoterodine 4mg
Open-Label Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg
The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events residual urinary volumes laboratory parameters changes in ECG physical and urological examinations and subjects assessment of treatment tolerance
Secondary efficacy variables include various parameters derived from micturition diaries count of subjects and their dose choice throughout the trial and subjects assessment of treatment efficacy
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