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Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

NCT01021332 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1067

Last updated 2024-12-03

Study results available
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Summary

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Conditions

  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia

Interventions

DRUG

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

oral

DRUG

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

oral

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma Global Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-26
Primary Completion
2011-12-14
Completion
2011-12-14

Countries

  • Austria
  • Belarus
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • 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 NCT01021332 on ClinicalTrials.gov