Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Collaborator: Procter and Gamble
• Treatments: Darifenacin

Criteria

Inclusion Criteria:

• Symptoms of OAB for at least six months prior to Visit 3

• Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:

• ≥ 1 UUIE on average per day and

• ≥ 10 episodes of micturition on average per day

Exclusion Criteria:

• A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization

• Post-void residual (PVR) urinary volume > 100 ml

• Clinically significant stress urinary incontinence as determined by the investigator

• Clinically significant bladder outlet obstruction as determined by the investigator

• Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply