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Completed

NCT Number: NCT00510406

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

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Key information

Conditions

Lower Urinary Tract Symptoms Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Linz, North-West, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin Hydrochloride

Drug

Alphablocker

Solifenacin succinate

Drug

antimuscarinic

Placebo

Drug

Placebo

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

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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)

Acronym: SATURN

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 2, 2007
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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