Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
NCT ID: NCT00507455
Last Updated: 2014-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
222 participants
INTERVENTIONAL
2007-06-30
2008-08-31
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
TRIPLE
Study Groups
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Placebo
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
Placebo to solifenacin
Placebo to tamsulosin
6 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
solifenacin succinate
Solifenacin succinate tablets
tamsulosin hydrochloride
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
9 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
solifenacin succinate
Solifenacin succinate tablets
tamsulosin hydrochloride
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Interventions
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solifenacin succinate
Solifenacin succinate tablets
tamsulosin hydrochloride
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Placebo to solifenacin
Placebo to tamsulosin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
* Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.
Exclusion Criteria
* Current urinary tract infection (UTI) or symptomatic and recurrent UTI of \> 3 episodes within 12 months.
* Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
* Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
* Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
45 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Homewood, Alabama, United States
La Mesa, California, United States
Long Beach, California, United States
San Bernardino, California, United States
San Diego, California, United States
Middlebury, Connecticut, United States
New Port Richey, Florida, United States
Coeur d'Alene, Idaho, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Watertown, Massachusetts, United States
Las Vegas, Nevada, United States
New York, New York, United States
Greensboro, North Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Edegem, , Belgium
Kortrijk, , Belgium
Olomouc, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Aachen, , Germany
Hagenow, , Germany
Landshut, , Germany
Mülheim, , Germany
Budapest, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Bialystok, , Poland
Mysłowice, , Poland
Szczecin, , Poland
Warsaw, , Poland
Countries
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References
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Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.
Other Identifiers
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2007-001268-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-CL-058
Identifier Type: -
Identifier Source: org_study_id
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