A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2007

Last Updated Date

December 9, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To 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 ]

Change History

Complete list of historical versions of study NCT00510406 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride [ Time Frame: 12 weeks ]

Descriptive Information

Brief Title ^ICMJE

A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

Official Title ^ICMJE

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)

Brief Summary

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.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Lower Urinary Tract Symptoms
Prostatic Hyperplasia

Intervention ^ICMJE

Drug: tamsulosin hydrochloride
Drug: solifenacin succinate
Drug: Placebo

Study Arms / Comparison Groups

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

919

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00510406

Responsible Party

Disclosure Office Europe, Astellas Pharma Europe BV

Study ID Numbers ^ICMJE

905-CL-052, EudraCT number: 2006-002072-18

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma Europe BV

Information Provided By

Astellas Pharma Inc

Verification Date

December 2008

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