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A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

NCT01638000 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1887

Last updated 2024-11-21

Study results available
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Summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Conditions

  • Urologic Diseases
  • Urinary Bladder, Overactive
  • Urinary Bladder Diseases

Interventions

DRUG

Mirabegron

oral tablet

DRUG

Solifenacin succinate

oral tablet

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Study Manager · Astellas Pharma Europe Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-12
Primary Completion
2013-04-24
Completion
2013-04-24

Countries

  • Armenia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT01638000 on ClinicalTrials.gov