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

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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.

Study NCT00507455. Last updated on September 25, 2008. Information provided by Astellas Pharma Inc

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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)

Brief Summary

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).

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).

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Lower Urinary Tract Symptoms
Bladder Outlet Obstruction

Intervention ^†

Drug: solifenacin succinate
Drug: tamsulosin hydrochloride
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

222

Start Date ^†

June 2007

Completion Date

August 2008

Eligibility 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

Gender

Male

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Belgium, Czech Republic, Germany, Hungary, Poland

Administrative Information Fields

NCT ID ^†

NCT00507455

Organization ID

905-CL-058

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2008

First Received Date ^†

July 25, 2007

Last Updated Date

September 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.