Status:
COMPLETED
Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin...
Detailed Description
Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the r...
Eligibility Criteria
Inclusion
- Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
- Patients with urgency episodes and frequent micturitions
- Written informed consent has been obtained
- Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume \< 50 mL
Exclusion
- Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
- Patients with obvious stress urinary incontinence
- Patients with complications or who have a past history of a bladder tumor
- Patients with urethral stricture or bladder neck stenosis
- Patients with a history of surgery causing damage to the pelvic plexus
- Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
- Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT00771394
Start Date
October 1 2008
End Date
January 1 2010
Last Update
February 15 2013
Active Locations (8)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan