Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004046

Trial Description

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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)

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Trial Acronym

SATURN

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00004046
  •   2012/07/16
  •   2007/07/31
  •   no
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Secondary IDs

  •   2006-002072-18 
  •   NCT00510406  (ClinicalTrials.gov)
  •   905-CL-052  (Astellas Pharma Inc)
  •   EudraCT number: 2006-002072-18 
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Health Condition or Problem studied

  •   Lower Urinary Tract Symptoms
  •   Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: tamsulosin hydrochloride
  •   Drug: solifenacin succinate
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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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; time frame: 12 weeks

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Secondary Outcome

- Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride; time frame: 12 weeks

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Countries of Recruitment

  •   Austria
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Netherlands
  •   Norway
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Slovakia
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2007/01/31
  •   919
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   45   Years
  •   no maximum age
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Additional 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

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Exclusion Criteria

- post void residual volume > 200 mL

- symptomatic urinary tract infection

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Addresses

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    • Astellas Pharma Inc
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    • Astellas Pharma Europe B.V.
    • Central Contact 
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  • start of 1:1-Block address public-contact
    • Astellas Pharma Europe B.V.
    • Central Contact 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2007/09/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.