Status:
COMPLETED
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Lead Sponsor:
Novartis
Conditions:
Overactive Bladder Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT00170755
Start Date
April 1 2002
End Date
January 1 2005
Last Update
January 17 2008
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108