Overactive Bladder Syndrome Clinical Trial
Official title:
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
This trial will provide long-term data on safety, satisfaction and maintenance on therapy of
fesoterodine (SPM 907) in subjects with overactive bladder syndrome.
Subjects completing the 12 week treatment period of SP584 had the opportunity to participate
if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the
dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be
followed on an annual basis.
The primary variables are long-term safety and tolerability, measured by observation and
assessment of adverse events and duration on therapy. Further safety variables include the
assessment of laboratory parameters, changes in ECG, physical exams and measurement of
residual urine.
Secondary efficacy variables included various parameters derived from micturition diaries
and the evaluation of Quality of Life questionnaires
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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