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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:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00510406
First received: July 31, 2007
Last updated: December 9, 2008
Last verified: December 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Genders 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
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 BV
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
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: December 9, 2008
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 21, 2013