A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
NCT ID: NCT00699049
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
94 participants
INTERVENTIONAL
2008-06-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alpha blocker and placebo
Alpha blocker
oral
placebo
oral
Alpha blocker and solifenacin
Alpha blocker
oral
solifenacin
oral
Interventions
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Alpha blocker
oral
placebo
oral
solifenacin
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptoms of urinary urgency (defined as a level of \>=3 in a 5 point urgency scale) at least two episode per 24 hours and
* symptoms of urinary frequency ( \>8 micturitions per 24 hours)
* On a stable dose of tamsulosin for at least 1 month
Exclusion Criteria
* Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
* Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
* Symptomatic acute urinary tract infection (UTI) during the screening period
* Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
* A 5-alpha reductase inhibitor if started less than 3 months prior to screening
* Patients with previous urethral, prostate or bladder neck surgery
50 Years
MALE
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
KYU-SUNG LEE
OTHER
Responsible Party
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KYU-SUNG LEE
professor
Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Cheonan, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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SMK-1
Identifier Type: -
Identifier Source: org_study_id
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