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

August 19, 2014 updated by: Astellas Pharma Inc

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

919

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • North-West
      • Linz, North-West, Austria
    • Styria
      • Graz, Styria, Austria
    • Vienna
      • Wien, Vienna, Austria
  • Czech Republic
      • Ostrava, Czech Republic
      • Plzen, Czech Republic
      • Prague, Czech Republic
      • Usti nad Labem, Czech Republic
  • Denmark
      • Aalborg, Denmark
      • Frederiksberg, Denmark
      • Roskilde, Denmark
      • Skejby, Denmark
  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
      • Lahti, Finland
      • Oulu, Finland
      • Tampere, Finland
  • France
      • Colmar, France
      • Cote de Nacre, France
      • Creteil, France
      • Marseille, France
      • Montlucon, France
      • Mulhouse, France
      • Nimes, France
      • Paris, France
      • Ploemer, France
  • Germany
      • Bad Segeberg, Germany
      • Bamberg, Germany
      • Bautzen, Germany
      • Dresden, Germany
      • Ganderkessee, Germany
      • Hagenow, Germany
      • Halle/Saale, Germany
      • Hamburg, Germany
      • Henningsdorf, Germany
      • Hettstedt, Germany
      • Koblenz, Germany
      • Leipzig, Germany
      • Lutherstadt Eisleben, Germany
      • Munchen, Germany
      • Münster, Germany
      • Neustadt i. Sachsen, Germany
      • Trier, Germany
      • Uetersen, Germany
  • Hungary
      • Budapest, Hungary
      • Eger, Hungary
      • Miskolc, Hungary
      • Nyiregyháza, Hungary
      • Sopron, Hungary
      • Szeged, Hungary
      • Szekszárd, Hungary
      • Tatabánya, Hungary
  • Netherlands
      • Utrecht, Netherlands
    • Friesland
      • Sneek, Friesland, Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
    • Noord-brabant
      • S'Hertogenbosch, Noord-brabant, Netherlands
      • Tilburg, Noord-brabant, Netherlands
    • Overijssel
      • Apeldoorn, Overijssel, Netherlands
      • Deventer, Overijssel, Netherlands
  • Norway
      • Fredrikstad, Norway
      • Oslo, Norway
      • Tonsberg, Norway
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Cracow, Poland
      • Katowice, Poland
      • Lublin, Poland
      • Lódz, Poland
      • Pulawy, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Portugal
      • Amadora-Sintra, Portugal
      • Carmo, Portugal
      • Coimbra (Covões), Portugal
      • Orta EPE, Portugal
      • Pulido Valente, Portugal
      • Santa Luzia, Portugal
      • Tomar, Portugal
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Slovakia
      • Nitra, Slovakia
      • Trencin, Slovakia
      • Zilina, Slovakia
  • Spain
      • Barcelona, Spain
      • La Coruna, Spain
      • Madrid, Spain
      • Pontevedra, Spain
      • Sevilla, Spain
  • Sweden
      • Kungälv, Sweden
      • Stockholm, Sweden
      • Sundsvall, Sweden
      • Uddevalla, Sweden
      • Upsala, Sweden
  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom
    • Lancashire
      • Chorley, Lancashire, United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom
      • Swansea, Wales, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: solifenacin succinate
antimuscarinic
Active Comparator: C
Drug: solifenacin succinate
antimuscarinic
Placebo Comparator: A
Drug: Placebo
Placebo
Active Comparator: D
Drug: solifenacin succinate
antimuscarinic
Active Comparator: E
Drug: tamsulosin hydrochloride
Alphablocker
Active Comparator: F
Drug: solifenacin succinate
antimuscarinic
Drug: tamsulosin hydrochloride
Alphablocker
Active Comparator: G
Drug: solifenacin succinate
antimuscarinic
Drug: tamsulosin hydrochloride
Alphablocker
Active Comparator: H
Drug: solifenacin succinate
antimuscarinic
Drug: tamsulosin hydrochloride
Alphablocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-CL-052
  • EudraCT number: 2006-002072-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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