Last reviewed · How we verify
Efficacy and Tolerability of Fesoterodine for Overactive Bladder Syndrome in Children: an Extension Study. (FOXY2015)
The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its efficacy for overactive bladder syndrome in children.
Details
| Lead sponsor | Stéphane Bolduc |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2015-10 |
| Completion | 2018-08 |
Conditions
- Overactive Bladder
Interventions
- Fesoterodine
Primary outcomes
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Fesoterodine. — 12 months
Side effects: the number of patients presenting side effects of grade 1, 2 and 3 (mild, moderate, severe). Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment will be aggregated to arrive at one reported value. Between study arms, for cardiovascular safety: mean difference in blood pressure, mean difference in heart rate, mean difference in QTcB. * Vital signs (blood pressure and heart rate), * Increase of more than 20% of heart rate at rest * Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg * Or symptoms suggesting it, without reaching those variations. o Parameters to be measure at each visit, to be obtained before and 1 hour after taking the medication. Blood tests profile comparing number of subjects with significant changes: Blood work (including hepatic and renal workups, electrolytes, Hb-Ht).
Countries
Canada