A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

NCT00510406 | Completed Phase 2

• 2 other identifiers: 905-CL-052EudraCT number: 2006-002072-18
• Study Type: interventional
• Target: 919
• Locations: 16 countries
• Sites: 98

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.

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Keywords

Lower Urinary Tract Symptoms; Treatment; Solifenacin succinate; Tamsulosin hydrochloride; Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride

  12 weeks

Study Arms (8)

A

PLACEBO COMPARATOR

Drug: Placebo

B

ACTIVE COMPARATOR

Drug: solifenacin succinate

C

ACTIVE COMPARATOR

Drug: solifenacin succinate

D

ACTIVE COMPARATOR

Drug: solifenacin succinate

E

ACTIVE COMPARATOR

Drug: tamsulosin hydrochloride

F

ACTIVE COMPARATOR

Drug: tamsulosin hydrochloride; Drug: solifenacin succinate

G

ACTIVE COMPARATOR

Drug: tamsulosin hydrochloride; Drug: solifenacin succinate

H

ACTIVE COMPARATOR

Drug: tamsulosin hydrochloride; Drug: solifenacin succinate

Interventions

tamsulosin hydrochloride DRUG

Alphablocker

E; F; G; H

solifenacin succinate DRUG

antimuscarinic

B; C; D; F; G; H

Placebo DRUG

Placebo

A

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (98)

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Linz, North-West, Austria

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Graz, Styria, Austria

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Vienna, Vienna, Austria

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Ostrava, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Ústí nad Labem, Czechia

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Aalborg, Denmark

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Frederiksberg, Denmark

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Roskilde, Denmark

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Skejby, Denmark

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Helsinki, Finland

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Kuopio, Finland

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Lahti, Finland

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Oulu, Finland

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Tampere, Finland

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Colmar, France

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Cote de Nacre, France

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Créteil, France

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Marseille, France

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Montluçon, France

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Mulhouse, France

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Nîmes, France

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Paris, France

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Ploemeur, France

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Bad Segeberg, Germany

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Bamberg, Germany

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Bautzen, Germany

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Dresden, Germany

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Eisleben Lutherstadt, Germany

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Ganderkessee, Germany

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Hagenow, Germany

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Halle, Germany

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Hamburg, Germany

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Henningsdorf, Germany

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Hettstedt, Germany

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Koblenz, Germany

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Leipzig, Germany

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München, Germany

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Münster, Germany

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Neustadt in Sachsen, Germany

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Trier, Germany

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Uetersen, Germany

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Budapest, Hungary

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Eger, Hungary

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Miskolc, Hungary

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Nyiregyháza, Hungary

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Sopron, Hungary

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Szeged, Hungary

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Szekszárd, Hungary

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Tatabánya, Hungary

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Nijmegen, Gelderland, Netherlands

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Maastricht, Limburg, Netherlands

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S'Hertogenbosch, North Brabant, Netherlands

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Tilburg, North Brabant, Netherlands

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Amsterdam, North Holland, Netherlands

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Apeldoorn, Overijssel, Netherlands

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Deventer, Overijssel, Netherlands

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Sneek, Provincie Friesland, Netherlands

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Utrecht, Utrecht, Netherlands

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Fredrikstad, Norway

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Oslo, Norway

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Tønsberg, Norway

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Bialystok, Poland

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Bydgoszcz, Poland

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Katowice, Poland

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Krakow, Poland

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Lódz, Poland

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Lublin, Poland

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Puławy, Poland

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Szczecin, Poland

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Warsaw, Poland

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Amadora-Sintra, Portugal

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Carmo, Portugal

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Coimbra (Covões), Portugal

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Orta EPE, Portugal

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Pulido Valente, Portugal

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Santa Luzia, Portugal

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Tomar, Portugal

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Moscow, Russia

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Saint Petersburg, Russia

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Nitra, Slovakia

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Trenčín, Slovakia

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Žilina, Slovakia

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A Coruña, Spain

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Barcelona, Spain

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Madrid, Spain

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Pontevedra, Spain

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Seville, Spain

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Kungälv, Sweden

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Stockholm, Sweden

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Sundsvall, Sweden

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Uddevalla, Sweden

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Uppsala, Sweden

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Reading, Berkshire, United Kingdom

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Chorley, Lancashire, United Kingdom

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Cardiff, Wales, United Kingdom

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Swansea, Wales, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23537687 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

FR (9); NL (9); AU (3); DK (4); GB (4); FI (5); SE (5); DE (18); PL (9); PT (7); ES (5); SL (3); HU (8); CZ (4); NO (3); RU (2)