Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
NCT ID: NCT01018511
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1334 participants
INTERVENTIONAL
2010-01-11
2011-03-01
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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Placebo
Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Placebo tamsulosin hydrochloride OCAS 0.4 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
tablet
TOCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
tablet
tamsulosin hydrochloride OCAS 0.4 mg
tablet
FDC 0.4 mg/6 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Placebo tamsulosin hydrochloride OCAS 0.4 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
tablet
FDC 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Placebo tamsulosin hydrochloride OCAS 0.4 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
tablet
Interventions
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Placebo tamsulosin hydrochloride OCAS 0.4 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
tablet
tamsulosin hydrochloride OCAS 0.4 mg
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A total International Prostate Symptom Score (IPSS) of ≥13
* A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
* A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)
Exclusion Criteria
* A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
* Evidence of a symptomatic urinary tract infection
45 Years
MALE
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Global Development
Locations
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Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Minsk, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Antwerp, , Belgium
Antwerp, , Belgium
Assebroek, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Sint-Truiden, , Belgium
Turnhout, , Belgium
Hradec Králové, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Roudnice nad Labem, , Czechia
Uherské Hradiště, , Czechia
Ústí nad Labem, , Czechia
Zdar, , Czechia
Aix-en-Provence, , France
Angers, , France
Bordeaux, , France
Colmar, , France
Dijon, , France
Dijon, , France
Lyon, , France
Montluçon, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Tours, , France
Bad Ems, , Germany
Bautzen, , Germany
Eisleben Lutherstadt, , Germany
Frankfurt, , Germany
Hagenow, , Germany
Halle, , Germany
Hamburg, , Germany
Henningsdorf, , Germany
Hettstedt, , Germany
Koblenz, , Germany
Leipzig, , Germany
Leipzig, , Germany
Neustadt in Sachsen, , Germany
Uetersen, , Germany
Budapest, , Hungary
Körmend, , Hungary
Nyíregyháza, , Hungary
Sopron, , Hungary
Szekszárd, , Hungary
Szentes, , Hungary
Tatabánya, , Hungary
Avellino, , Italy
Bari, , Italy
Bergamo, , Italy
Catania, , Italy
Catanzaro, , Italy
Florence, , Italy
Palermo, , Italy
Treviglio, , Italy
Turin, , Italy
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Doetinchem, , Netherlands
Eindhoven, , Netherlands
Etten-Leur, , Netherlands
Maastricht, , Netherlands
Sneek, , Netherlands
Sneek, , Netherlands
Tilburg, , Netherlands
Winterswijk, , Netherlands
Bielsko-Biala, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Puławy, , Poland
Warsaw, , Poland
Więcbork, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Nitra, , Slovakia
Piešťany, , Slovakia
Prešov, , Slovakia
Skalica, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Birmingham, , United Kingdom
Bristol, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
Chorley, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Northwood, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Reading, , United Kingdom
Reading, , United Kingdom
Reading, , United Kingdom
Sheffield, , United Kingdom
Taunton, , United Kingdom
Torquay, , United Kingdom
Countries
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References
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van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2008-001211-37
Identifier Type: OTHER
Identifier Source: secondary_id
905-CL-055
Identifier Type: -
Identifier Source: org_study_id