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Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

NCT01018511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1334

Last updated 2024-12-03

Study results available
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Summary

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

Conditions

  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Interventions

DRUG

Placebo tamsulosin hydrochloride OCAS 0.4 mg

tablet

DRUG

Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg

tablet

DRUG

Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg

tablet

DRUG

tamsulosin hydrochloride OCAS 0.4 mg

tablet

DRUG

tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)

tablet

DRUG

tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)

tablet

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-11
Primary Completion
2011-03-01
Completion
2011-03-01

Countries

  • Austria
  • Belarus
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • United Kingdom

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 NCT01018511 on ClinicalTrials.gov