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

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT00171184

Run by

Novartis

People needed

400

Starts

2005-04-01

Expected to finish

2006-06-01

Last updated by the study team

2017-05-18

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scott Department of Urology Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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