Urinary Bladder, Overactive Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study.
All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into
VESIcare® (solifenacin succinate) or placebo group.
The study duration consists of a screening period which includes a minimum of a 14 day
treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week
treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout
period; 12 week double-blind treatment.
Primary efficacy will be based on OAB-q symptom bother score.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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