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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01898624
Other study ID # BE0004
Secondary ID
Status Completed
Phase N/A
First received July 10, 2013
Last updated February 1, 2018
Start date December 4, 2012
Est. completion date January 10, 2018

Study information

Verified date February 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 10, 2018
Est. primary completion date January 10, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
mirabegron
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma 12 weeks
Secondary Changes in OABSS (Over Active Bladder Symptoms Score) OABSS is judged by investigator Baseline and 12 weeks of treatment
See also
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Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
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Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
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Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
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Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Completed NCT00910845 - Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3