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

NCT00507455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2014-08-06

Study results available
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Summary

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

Conditions

  • Lower Urinary Tract Symptoms
  • Bladder Outlet Obstruction

Interventions

DRUG

solifenacin succinate

Solifenacin succinate tablets

DRUG

tamsulosin hydrochloride

Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets

DRUG

Placebo to solifenacin

DRUG

Placebo to tamsulosin

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma US, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507455 on ClinicalTrials.gov