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Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00507455
First received: July 25, 2007
Last updated: September 25, 2009
Last verified: September 2009
History of Changes
  Purpose

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).


Condition Intervention Phase
Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
 Drug: solifenacin succinate
Drug: tamsulosin hydrochloride
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)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Evaluate the urodynamic variables [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability, safety, and efficacy of 2 doses of solifenacin succinate with tamsulosin hydrochloride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 222
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose 1 solifenacin plus tamsulosin
 Drug: solifenacin succinate
oral
Other Name: YM905
Drug: tamsulosin hydrochloride
oral
Other Name: Omnic
Experimental: 2
dose 2 solifenacin plus tamsulosin
 Drug: solifenacin succinate
oral
Other Name: YM905
Drug: tamsulosin hydrochloride
oral
Other Name: Omnic
Placebo Comparator: 3 Drug: placebo
oral

Detailed Description:

A 3 arm (2 active, 1 placebo) study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with LUTS and BOO
  • BOO indication by a BOOI ≥ 20
  • Subject has a total IPPS score of ≥ 8 (Inclusion criteria for Baseline also)

Exclusion Criteria:

  • History of urinary retention in preceding 12 months
  • Current UTI or symptomatic and recurrent UTI of > 3 episodes within 12 months.
  • Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
  • Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
  • Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507455

  Hide Study Locations
Locations
United States, Alabama
Homewood, Alabama, United States, 35209
United States, California
La Mesa, California, United States, 91942
Long Beach, California, United States, 90806
San Bernardino, California, United States, 92404
San Diego, California, United States, 92108
United States, Connecticut
Middlebury, Connecticut, United States, 06762
United States, Florida
New Port Richey, Florida, United States, 34655
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Iowa
Des Moines, Iowa, United States, 50309
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Watertown, Massachusetts, United States, 02472
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
New York, New York, United States, 10021
United States, North Carolina
Greensboro, North Carolina, United States, 27403
United States, Texas
Austin, Texas, United States, 78705
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22908
Belgium
Edegem, Belgium, 2650
Kortrijk, Belgium
Czech Republic
Olomouc, Czech Republic
Pilsen, Czech Republic
Prague, Czech Republic
Germany
Aachen, Germany
Hagenow, Germany
Landshut, Germany
Muelheim, Germany
Hungary
Budapest, Hungary
Szeged, Hungary
Szekszard, Hungary
Poland
Bialystok, Poland
Myslowice, Poland
Szczecin, Poland
Warszawa, Poland
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00507455     History of Changes
Other Study ID Numbers: 905-CL-058
Study First Received: July 25, 2007
Last Updated: September 25, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency

Keywords provided by Astellas Pharma Inc:
Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Treatment
Solifenacin Succinate
Tamsulosin hydrochloride

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
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 June 18, 2013