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A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

NCT01340027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1307

Last updated 2024-10-31

Study results available
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Summary

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

Conditions

  • Urologic Diseases
  • Urinary Bladder Diseases
  • Urological Manifestations
  • Signs and Symptoms
  • Urinary Bladder, Overactive

Interventions

DRUG

Mirabegron

oral

DRUG

Solifenacin succinate

oral

DRUG

Placebo

oral

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Study Physician · Astellas Pharma Europe B.V.

  • Principal Investigator · Bristol Urological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-29
Primary Completion
2012-06-28
Completion
2012-06-28

Countries

  • Belarus
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Ukraine
  • 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 NCT01340027 on ClinicalTrials.gov