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Beta-3 Adrenoceptor Agonist

Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

Phase 4
Waitlist Available
Led By Anil Kapoor, MD, FRCSC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up timeline: 4 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing a new OAB treatment combining a β3-adrenoceptor agonist (mirabegron) with an α-blocker. The goal is to see if this is a safe and effective treatment for OAB symptoms in male patients with BPH.

Eligible Conditions
  • Overactive Bladder
  • Enlarged Prostate

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~timeline: 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and timeline: 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
International Prostate Symptom Score (IPSS)
Overactive Bladder Symptom Score (OABSS)
Quality of Life Score (QoLS)
Secondary study objectives
Adverse Events

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control2 Interventions
(Mirabegron + Tamsulosin)
Group II: Control GroupPlacebo Group1 Intervention
(Placebo + Tamsulosin)

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
202 Previous Clinical Trials
26,725 Total Patients Enrolled
Anil Kapoor, MD, FRCSCPrincipal InvestigatorMcMaster University
3 Previous Clinical Trials
70 Total Patients Enrolled
~50 spots leftby Dec 2025
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