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A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

NCT02045862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1829

Last updated 2024-10-31

Study results available
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Summary

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Conditions

  • Urinary Bladder Overactive
  • Overactive Bladder
  • Urgency Incontinence
  • Urinary Bladder Diseases\Urologic Diseases

Interventions

DRUG

Solifenacin succinate

Participants received solifenacin 5 mg orally once a day at the same time each day.

DRUG

Mirabegron

Participants received mirabegron 50 mg orally once a day at the same time each day.

DRUG

Placebo to match solifenacin

Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

DRUG

Placebo to match mirabegron

Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-17
Primary Completion
2016-09-08
Completion
2016-09-08

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02045862 on ClinicalTrials.gov