Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction - Full Text View

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 II

ChemIDplus related topics:

Succinic acid Solifenacin succinate Solifenacin Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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)

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
1: Experimental dose 1 solifenacin plus tamsulosin	Drug: solifenacin succinate oral Drug: tamsulosin hydrochloride oral
2: Experimental dose 2 solifenacin plus tamsulosin	Drug: solifenacin succinate oral Drug: tamsulosin hydrochloride oral
3: Placebo Comparator	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

Show 33 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Use Central Contact	Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	905-CL-058
First Received:	July 25, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00507455
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

Study placed in the following topic categories:

Urologic Diseases

Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate

Urinary Bladder Diseases

Tamsulosin

Urinary Bladder Neck Obstruction

Additional relevant MeSH terms:

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Antineoplastic Agents

Physiological Effects of Drugs

Urethral Obstruction

Adrenergic alpha-Antagonists

Cholinergic Agents

Pharmacologic Actions

Muscarinic Antagonists

Therapeutic Uses

Urethral Diseases

Adrenergic Antagonists

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00507455