Clinical trial NCT00510406: A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
Official title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Keywords: Lower Urinary Tract Symptoms
Treatment
Solifenacin succinate
Tamsulosin hydrochloride
Prostatic Hyperplasia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 919
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Detailed description: Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Eligibility criteria: Inclusion Criteria:

* male patients with LUTS associated with BPH diagnosed \> 3 months
* IPSS score \> 13
* voiding and storage symptoms
* maximum flow rate of \> 4 mL/s and \< 15 mL/s

Exclusion Criteria:

* post void residual volume \> 200 mL
* symptomatic urinary tract infection

Primary outcomes:
measure: Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH
timeFrame: 12 weeks
Secondary outcomes:
measure: Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
state: North-West
city: Graz
country: Austria
state: Styria
city: Wien
country: Austria
state: Vienna
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Prague
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Aalborg
country: Denmark
city: Frederiksberg
country: Denmark
city: Roskilde
country: Denmark
city: Skejby
country: Denmark
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Colmar
country: France
city: Cote de Nacre
country: France
city: Creteil
country: France
city: Marseille
country: France
city: Montlucon
country: France
city: Mulhouse
country: France
city: Nimes
country: France
city: Paris
country: France
city: Ploemer
country: France
city: Bad Segeberg
country: Germany
city: Bamberg
country: Germany
city: Bautzen
country: Germany
city: Dresden
country: Germany
city: Ganderkessee
country: Germany
city: Hagenow
country: Germany
city: Halle/Saale
country: Germany
city: Hamburg
country: Germany
city: Henningsdorf
country: Germany
city: Hettstedt
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Lutherstadt Eisleben
country: Germany
city: Munchen
country: Germany
city: Münster
country: Germany
city: Neustadt i. Sachsen
country: Germany
city: Trier
country: Germany
city: Uetersen
country: Germany
city: Budapest
country: Hungary
city: Eger
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyháza
country: Hungary
city: Sopron
country: Hungary
city: Szeged
country: Hungary
city: Szekszárd
country: Hungary
city: Tatabánya
country: Hungary
city: Sneek
country: Netherlands
state: Friesland
city: Nijmegen
country: Netherlands
state: Gelderland
city: Maastricht
country: Netherlands
state: Limburg
city: S'Hertogenbosch
country: Netherlands
state: Noord-brabant
city: Tilburg
country: Netherlands
state: Noord-brabant
city: Amsterdam
country: Netherlands
state: Noord-Holland
city: Apeldoorn
country: Netherlands
state: Overijssel
city: Deventer
country: Netherlands
state: Overijssel
city: Utrecht
country: Netherlands
city: Fredrikstad
country: Norway
city: Oslo
country: Norway
city: Tonsberg
country: Norway
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Cracow
country: Poland
city: Katowice
country: Poland
city: Lublin
country: Poland
city: Lódz
country: Poland
city: Pulawy
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Amadora-Sintra
country: Portugal
city: Carmo
country: Portugal
city: Coimbra (Covões)
country: Portugal
city: Orta EPE
country: Portugal
city: Pulido Valente
country: Portugal
city: Santa Luzia
country: Portugal
city: Tomar
country: Portugal
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Nitra
country: Slovakia
city: Trencin
country: Slovakia
city: Zilina
country: Slovakia
city: Barcelona
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Pontevedra
country: Spain
city: Sevilla
country: Spain
city: Kungälv
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Uddevalla
country: Sweden
city: Upsala
country: Sweden
city: Reading
country: United Kingdom
state: Berkshire
city: Chorley
country: United Kingdom
state: Lancashire
city: Cardiff
country: United Kingdom
state: Wales
city: Swansea
country: United Kingdom
state: Wales
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19.