Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00366002
Eligibility Criteria:
Inclusion Criteria:
* • Symptoms of OAB for at least six months prior to randomization
* ≥ 8 micturitions on average/24 hours
* ≥ 1 urgency episodes on average/24 hours
* with or without UUIE
* Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
* Patients without prior darifenacin treatment
Exclusion Criteria:
* • A mean daily urinary volume \>3000 mL or a mean volume voided/micturition of \>300 mL as verified in the micturition diary for two consecutive days prior to Baseline
* Males with post-void residual (PVR) urinary volume \>200 mL at Baseline
* Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
* Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
Other protocol-defined inclusion / exclusion criteria may apply
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00366002
Study Brief:
Protocol Section:
NCT00366002