A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
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|ClinicalTrials.gov Identifier: NCT00171145|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 23, 2008
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Drug: Darifenacin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.|
|Study Start Date :||April 2004|
|Actual Study Completion Date :||December 2004|
Darifenacin 15 mg tablets once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo tablets once daily
- Change from baseline in warning time at week 12.
- Change in warning time at weeks 2 & 6.
- Change in frequency of urge incontinence episodes.
- Change in frequency of micturitions.
- Change in mean volume per void.
- Change in frequency of urgency.
- Safety and tolerability.
- Quality of life.
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): NCT00171145
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|