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

Tracking Information

First Received Date ^ICMJE

July 25, 2007

Last Updated Date

September 25, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Evaluate the urodynamic variables [ Time Frame: 12 weeks ]

Change History

Complete list of historical versions of study NCT00507455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Tolerability, safety, and efficacy of 2 doses of solifenacin succinate with tamsulosin hydrochloride [ Time Frame: 12 weeks ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Lower Urinary Tract Symptoms
Bladder Outlet Obstruction

Intervention ^ICMJE

Drug: solifenacin succinate
Drug: tamsulosin hydrochloride
Drug: placebo

Study Arms / Comparison Groups

Experimental: dose 1 solifenacin plus tamsulosin
Experimental: dose 2 solifenacin plus tamsulosin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

222

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00507455

Responsible Party

Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc

Study ID Numbers ^ICMJE

905-CL-058

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP