The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder...
Date First Received: September 13, 2005
Last Updated: July 9, 2008
Verified by: Astellas Pharma Inc, October 2006
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Solifenacin succinate
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Symptoms of overactive bladder
- Must be able to complete the micturition diary
Exclusion Criteria:
- Pregnant or lactating
- Clinically significant outflow obstruction
- Significant post void residual urine
- Significant stress incontinence
- Urinary tract infection
- Chronic inflammation
- Bladder stones
- Previous pelvic radiation therapy
- Previous or current malignant disease of the pelvic organs
- Uncontrolled narrow angle glaucoma
- Urinary or gastric retention
- Electrostimulation therapy
- Bladder training
- Diabetic neuropathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Astellas Pharma Inc
Overall Clinical Trial Officials and Contacts
Prof. Jeong Gu Lee Principal Investigator Department of Urology, Korea University Anam Hospital
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189800
Study ID Number: 90502/KOoTD01
ClinicalTrials.gov Identifier: NCT00189800
Health Authority: Korea: Food and Drug Administration
Clinical Trials Authorship and Review
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