A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lower Urinary Tract Symptoms; Prostatic Hyperplasia
Intervention: tamsulosin hydrochloride (Drug); solifenacin succinate (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma Europe BV
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
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
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Prague, Czech Republic
Plzen, Czech Republic
Ostrava, Czech Republic
Usti nad Labem, Czech Republic
Skejby, Denmark
Aalborg, Denmark
Frederiksberg, Denmark
Roskilde, Denmark
Tampere, Finland
Oulu, Finland
Lahti, Finland
Kuopio, Finland
Helsinki, Finland
Paris, France
Cote de Nacre, France
Colmar, France
Montlucon, France
Creteil, France
Ploemer, France
Marseille, France
Mulhouse, France
Nimes, France
Hagenow, Germany
Neustadt i. Sachsen, Germany
Lutherstadt Eisleben, Germany
Koblenz, Germany
Dresden, Germany
Munchen, Germany
Bautzen, Germany
Trier, Germany
Hettstedt, Germany
Ganderkessee, Germany
Halle/Saale, Germany
Henningsdorf, Germany
Bamberg, Germany
Münster, Germany
Hamburg, Germany
Uetersen, Germany
Leipzig, Germany
Bad Segeberg, Germany
Budapest, Hungary
Nyiregyháza, Hungary
Tatabánya, Hungary
Szeged, Hungary
Miskolc, Hungary
Sopron, Hungary
Szekszárd, Hungary
Eger, Hungary
Utrecht, Netherlands
Tonsberg, Norway
Fredrikstad, Norway
Oslo, Norway
Lublin, Poland
Bydgoszcz, Poland
Cracow, Poland
Katowice, Poland
Lódz, Poland
Szczecin, Poland
Pulawy, Poland
Bialystok, Poland
Warszawa, Poland
Tomar, Portugal
Carmo, Portugal
Santa Luzia, Portugal
Pulido Valente, Portugal
Amadora-Sintra, Portugal
Coimbra (Covões), Portugal
Orta EPE, Portugal
St. Petersburg, Russian Federation
Moscow, Russian Federation
Zilina, Slovakia
Trencin, Slovakia
Nitra, Slovakia
Sevilla, Spain
La Coruna, Spain
Barcelona, Spain
Madrid, Spain
Pontevedra, Spain
Stockholm, Sweden
Upsala, Sweden
Kungälv, Sweden
Uddevalla, Sweden
Sundsvall, Sweden
Reading, Berkshire, United Kingdom
Sneek, Friesland, Netherlands
Nijmegen, Gelderland, Netherlands
Chorley, Lancashire, United Kingdom
Maastricht, Limburg, Netherlands
Amsterdam, Noord-Holland, Netherlands
Tilburg, Noord-brabant, Netherlands
S'Hertogenbosch, Noord-brabant, Netherlands
Linz, North-West, Austria
Apeldoorn, Overijssel, Netherlands
Deventer, Overijssel, Netherlands
Graz, Styria, Austria
Wien, Vienna, Austria
Swansea, Wales, United Kingdom
Cardiff, Wales, United Kingdom
Additional Information
Starting date: January 2007
Ending date: September 2007
Last updated: January 8, 2008
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