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

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ClinicalTrials.gov Identifier: NCT00510406
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Prostatic Hyperplasia Drug: tamsulosin hydrochloride Drug: solifenacin succinate Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 919 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007


Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
Placebo

Active Comparator: B Drug: solifenacin succinate
antimuscarinic

Active Comparator: C Drug: solifenacin succinate
antimuscarinic

Active Comparator: D Drug: solifenacin succinate
antimuscarinic

Active Comparator: E Drug: tamsulosin hydrochloride
Alphablocker

Active Comparator: F Drug: tamsulosin hydrochloride
Alphablocker

Drug: solifenacin succinate
antimuscarinic

Active Comparator: G Drug: tamsulosin hydrochloride
Alphablocker

Drug: solifenacin succinate
antimuscarinic

Active Comparator: H Drug: tamsulosin hydrochloride
Alphablocker

Drug: solifenacin succinate
antimuscarinic




Primary Outcome Measures :
  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 Outcome Measures :
  1. Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510406


  Show 98 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00510406     History of Changes
Other Study ID Numbers: 905-CL-052
EudraCT number: 2006-002072-18
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Lower Urinary Tract Symptoms
Treatment
Solifenacin succinate
Tamsulosin hydrochloride
Prostatic Hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Tamsulosin
Solifenacin Succinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents