A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder Syndrome
Intervention: Darifenacin (Drug)
Phase: Phase 3
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: East Hanover NJ
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the
long-term treatment of adult patients with overactive bladder.
Official title: A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
Long term efficacy on the symptoms of overactive bladder
King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),
Minimum age: 18 Years.
Maximum age: N/A.
- Adult patients with overactive bladder who completed a previous darifenacin short-term
- Patients capable of independent toileting and able of independently completing the
- 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.
Locations and Contacts
Novartis, East Hanover, New Jersey 07936-108, United States
Starting date: April 2002
Ending date: January 2005
Last updated: January 15, 2008