Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
NCT00171184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2017-05-18
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.
Conditions
Interventions
- DRUG
-
Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
- DRUG
-
Placebo tablet once daily with sham titration
Sponsors & Collaborators
-
Procter and Gamble
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Novartis · East Hanover NJ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Completion
- 2006-06-30
Countries
- United States
Study Locations
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