Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
This study has been completed.
Information provided by:
First received: September 9, 2005
Last updated: January 18, 2008
Last verified: January 2008
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary Outcome Measures:
- Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
- Effects on other cognitive domains measured by various tests at week 1,2 and 3.
|Study Start Date:||February 2005|
|Study Completion Date:||May 2005|
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
Other Name: Enablex
Active Comparator: 2
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
Placebo Comparator: 3
Placebo once daily tablet (sham titration)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170768
|United States, District of Columbia|
|Washington Neuropsychological Institute LLC Georgetown|
|Washington, District of Columbia, United States, 20016|
Sponsors and Collaborators
|Study Chair:||Novartis||East Hanover NJ|