NCT01919047

Brief Summary

This study is to determine the following information.

  1. 1.The occurrence of adverse drug reactions in clinical settings.
  2. 2.Factors potentially impacting safety, effectiveness, and other aspects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

August 6, 2013

Last Update Submit

October 2, 2015

Conditions

Overactive Bladder

Keywords

overactive bladdermirabegronoccurrence of adverse eventsOveractive Bladder Symptom Score

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events and adverse drug reactions

    For 12 weeks

Secondary Outcomes (2)

  • Changes in OABSS (overactive bladder symptom score)

    baseline and at 12 weeks (or last observation period)

  • Items of particular interest

    baseline and at 12 weeks (or last observation period)

Study Arms (1)

Betanis group

Patients receiving Betanis for Overactive Bladder

Drug: Betanis

Interventions

BetanisDRUG

Oral

Also known as: Mirabegron, YM178
Betanis group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

You may qualify if:

  • Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 8, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

JP(8)