A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Completed · Phase 3

Conditions studied: Overactive Bladder Syndrome

In brief

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Key facts

Study ID

NCT00170755

Run by

Novartis

People needed

718

Starts

2002-04-01

Expected to finish

2005-01-01

Last updated by the study team

2008-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
• Patients capable of independent toileting and able of independently completing the patient diary.

You may not qualify if…

• Patients in whom the use of anticholinergic drugs was contraindicated
• Evidence of severe liver disease
• Patients with other clinically significant urinary or gynecological conditions
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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