NCT01898624

Brief Summary

To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

7 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

December 4, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

5.1 years

First QC Date

July 10, 2013

Last Update Submit

February 1, 2018

Conditions

Overactive Bladder

Keywords

mirabegronOveractive BladderBetanis®glaucoma

Outcome Measures

Primary Outcomes (1)

  • The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma

    12 weeks

Secondary Outcomes (1)

  • Changes in OABSS (Over Active Bladder Symptoms Score)

    Baseline and 12 weeks of treatment

Study Arms (1)

Betanis group

mirabegron treated group

Drug: mirabegron

Interventions

mirabegronDRUG

oral

Also known as: Betanis, YM178
Betanis group

Eligibility Criteria

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

OAB patients with coexisting glaucoma treated with mirabegron

You may qualify if:

  • diagnosed as OAB and treated with mirabegron
  • diagnosed as glaucoma (including normal tension glaucoma)
  • having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveGlaucoma

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 SymptomsOcular HypertensionEye Diseases

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 12, 2013

Study Start

December 4, 2012

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

JP(7)