Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT00171184|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Darifenacin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder|
|Study Start Date :||April 2005|
|Actual Study Completion Date :||June 2006|
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo tablet once daily with sham titration
- Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
- Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
- Safety and tolerability.
- Quality of life at week 6 and/or 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171184
|United States, Texas|
|Scott Department of Urology Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Chair:||Novartis||East Hanover NJ|