Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine
fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive
bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter
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 3 treatment arms receiving
either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, 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 following safety variables were observed and
assessed: adverse events, change in residual urinary volume (mL), change in laboratory
parameters, change in vital signs, change in electrocardiogram (ECG), change in physical
examination and change in urological/urogynecological examination.
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