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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00510406
First received: July 31, 2007
Last updated: August 19, 2014
Last verified: August 2014
  Purpose
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 Intervention Phase
Lower Urinary Tract Symptoms Prostatic Hyperplasia Drug: tamsulosin hydrochloride Drug: solifenacin succinate Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

Enrollment: 919
Study Start Date: January 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510406

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

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
Study First Received: July 31, 2007
Last Updated: August 19, 2014

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

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Pathologic Processes
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
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

ClinicalTrials.gov processed this record on June 26, 2017