NCT01901120

Brief Summary

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 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

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.9 years

First QC Date

July 10, 2013

Last Update Submit

October 30, 2016

Conditions

Overactive Bladder

Keywords

Betanis®mirabegronOveractive Bladder

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    Up to 36 months after treatment

Secondary Outcomes (1)

  • Overactive Bladder Symptom Score (OABSS)

    At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment

Study Arms (1)

Betanis

the usual adult dosage of mirabegron once daily after a meal

Drug: Betanis

Interventions

BetanisDRUG

oral

Also known as: YM178, mirabegron
Betanis

Eligibility Criteria

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

Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

You may qualify if:

  • Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chūbu, Chubu, Japan

Location

Unknown Facility

Chugoku, Chugoku, Japan

Location

Unknown Facility

Hokkaido, Hokkaido, Japan

Location

Unknown Facility

Kansai, Kansai, Japan

Location

Unknown Facility

Kanto, Kanto, Japan

Location

Unknown Facility

Kyushu, Kyushu, Japan

Location

Unknown Facility

Shikoku, Shikoku, Japan

Location

Unknown Facility

Tōhoku, Tohoku, 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 DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

JP(8)