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Beta-3 Adrenergic Agonist

Mirabegron for Overactive Bladder (Dolphin Trial)

Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 12, 14
Awards & highlights

Dolphin Trial Summary

This trial will evaluate the effectiveness of mirabegron in children with OAB, as well as its safety and how it is metabolized in the body.

Eligible Conditions
  • Overactive Bladder
  • Mirabegron Pharmacokinetics

Dolphin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 12, 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 12, 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years
Secondary outcome measures
Change From Baseline in Post Void Residual (PVR) Volume
Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years
Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
+13 more

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188
7%
fatigue
7%
asthma
7%
urinary tract infection
7%
headache
7%
gastritis
7%
diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirabegron
Placebo

Dolphin Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Mirabegron (5 to <12 Years)Experimental Treatment1 Intervention
Participants aged 5 to < 12 years received initial dose of 25 milligram (mg) of mirabegron orally once daily based on weight (pediatric equivalent dose of 25 mg [PED25]) on day 1. Participants with a body weight ≥ 35 kilogram (kg) received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the pediatric equivalent dose of 50 mg [PED50] based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group II: Mirabegron (12 to <18 Years)Experimental Treatment1 Intervention
Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group III: Placebo (12 to <18 Years)Placebo Group1 Intervention
Participants aged 12 to < 18 years received placebo matched to mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group IV: Placebo (5 to <12 Years)Placebo Group1 Intervention
Participants aged 5 to < 12 years received placebo matched to mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
2008
Completed Phase 4
~18640

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
195 Previous Clinical Trials
121,471 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.
1,671 Previous Clinical Trials
988,353 Total Patients Enrolled

Media Library

Mirabegron (Beta-3 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04641975 — Phase 3
Overactive Bladder Research Study Groups: Placebo (12 to <18 Years), Placebo (5 to <12 Years), Mirabegron (12 to <18 Years), Mirabegron (5 to <12 Years)
Overactive Bladder Clinical Trial 2023: Mirabegron Highlights & Side Effects. Trial Name: NCT04641975 — Phase 3
Mirabegron (Beta-3 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641975 — Phase 3
~6 spots leftby Jun 2025
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