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

NCT00510406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 919

Last updated 2014-08-20

No results posted yet for this study

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.

Conditions

  • Lower Urinary Tract Symptoms
  • Prostatic Hyperplasia

Interventions

DRUG

tamsulosin hydrochloride

Alphablocker

DRUG

solifenacin succinate

antimuscarinic

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Austria
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00510406 on ClinicalTrials.gov