- Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening
bladder diary prior to Start of Placebo run in visit (Visit 2)
- Mean number of micturition related urgency episodes >=3 per 24 hours as verified by
the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency
episodes are defined as those with Urinary Sensation Scale rating >=3)
- Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8
episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency
episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in
the bed time section of the bladder diary)
- A known recent history or previous diagnosis of any sleep disorder such as obstructive
sleep apnea, primary insomnia, periodic limb movement, parasomnia
- Nocturia due to other underlying uncontrolled conditions, such as congestive heart
failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.