Overactive Bladder Syndrome Clinical Trial
Official title:
A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2
week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving
either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or
placebo during the Double-Blind Treatment Period.
Two primary efficacy variables will be assessed for submission in the United States: change
in the average number of micturitions (frequency) per 24 hours and the change in the average
number of urge incontinence episodes per 24 hours. For the submissions in the European
Union, the first primary variable will be the change in the average number of micturitions
(frequency) per 24 hours and the co-primary variable is the treatment response, based on a
treatment benefit scale. All continuous variables will be measured as changes from baseline
to value after 12 weeks of treatment.
The most important safety variables included the assessment of adverse events, laboratory
parameters, changes in ECG, physical exams and measurement of residual urine.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
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