Status:
COMPLETED
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Lead Sponsor:
Novartis
Collaborating Sponsors:
Procter and Gamble
Conditions:
Overactive Bladder
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- Symptoms of OAB for at least six months prior to Visit 3
- Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
- ≥ 1 UUIE on average per day and
- ≥ 10 episodes of micturition on average per day
Exclusion
- A total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization
- Post-void residual (PVR) urinary volume \> 100 ml
- Clinically significant stress urinary incontinence as determined by the investigator
- Clinically significant bladder outlet obstruction as determined by the investigator
- Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.
- Other protocol inclusion / exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00171184
Start Date
April 1 2005
End Date
June 1 2006
Last Update
May 18 2017
Active Locations (1)
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1
Scott Department of Urology Baylor College of Medicine
Houston, Texas, United States, 77030