A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

NCT04562090 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 178-MA-2295CTR20202160
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study was to evaluate the efficacy of mirabegron for the treatment of overactive bladder (OAB) in Chinese participants. This study also evaluated the safety of mirabegron for the treatment of OAB in Chinese participants, evaluated other efficacy variables of mirabegron for the treatment of OAB and explored different mirabegron starting doses.

Conditions

Urge Incontinence; Overactive Bladder (OAB)

Keywords

mirabegron

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group

  A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.

  Baseline, week 12

Secondary Outcomes (8)

• Number of Participants With Treatment Emergent Adverse Events

  From first dose up to 30 days after last dose (up to week 16)

• Change From Baseline to Week 12 in Post Void Residual (PVR) Volume

  Baseline, week 12

• Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours

  Baseline and weeks 4, 8, and 12

• Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours

  Baseline and weeks 4, 8, and 12

• Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours

  Baseline and weeks 4, 8, and 12

Study Arms (2)

Mirabegron 25 mg

EXPERIMENTAL

Participants received single oral dose of Mirabegron 25 milligrams (mg) tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator.

Drug: mirabegron

Mirabegron 50 mg

EXPERIMENTAL

Participants received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks.

Drug: mirabegron

Interventions

mirabegron DRUG

Mirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet

Also known as: Betmiga

Mirabegron 25 mg; Mirabegron 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant should exhibit symptoms of OAB for at least 12 weeks before initiation of the screening period.
• Participant should have an average of ≥ 8 micturitions/24 hours.
• Participant should have an average of ≥ 1 episode of grade 3 or 4 (PPIUS) urgency or urgency incontinence/24 hours, during a 3-day micturition diary period.
• Female participant is not pregnant and at least one of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational product (IP) administration.
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
• Female participant must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final IP administration.
• Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and 30 days after final IP administration.
• Male participant must not donate sperm during the treatment period and for 30 days after final IP administration.
• Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
• Participant agrees not to participate in another interventional study while participating in the present study, defined as 28 days prior screening until completion of the last study visit.

You may not qualify if:

• Participant has stress urinary incontinence as a predominant symptom.
• Participant has an average total daily urine volume \> 3000 mL (as recorded in a 3-day voiding diary period).
• Participant has indwelling catheter or practices intermittent self-catheterization.
• Participant has neurogenic detrusor overactivity or indicated pathology other than OAB.
• Participant as monosymptomatic enuresis.
• Participant has post void residual (PVR) volume of ≥ 100 mL or a clinically significant lower urinary tract obstructive disease, except if successfully treated.
• Participant has anatomical anomalies (surgically treated or untreated) that affect lower urinary tract function.
• Participant with hematuria on dipstick test. In the case of hematuria on dipstick test in a female during menstruation, the test can be repeated before randomization (after the end of menstruation).
• Participant has lower urinary tract stones or clinically significant kidney stones requiring treatment.
• Participant has interstitial cystitis.
• Participant has suffered from chronic urinary tract infection (UTI) or has had more than 3 ETIs in the 2 months prior to visit 1/week -1 to -2 (screening).
• Participant has uncontrolled hypertension (sitting systolic blood pressure \[SBP\] ≥ 180 mmHg or diastolic blood pressure \[DBP\] ≥ 110 mmHg).
• Participant has pulse rate ≥ 110 beats per minute (bpm) or \<50 bpm.
• Participant has corrected QT interval by Fredericia (QTcF) \> 440 msec on screening ECG or a risk of QT prolongation (e.g., hypokalemia, long QT syndrome \[LQTS\] or family history of LQTS or exercise-induced syncope).
• Participant's aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≥ 2 × upper limit of normal (ULN) or total bilirubin (TBL) is ≥ 1.5 × ULN according to age and sex (participants with Gilbert's syndrome are excepted from the bilirubin threshold).

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (15)

Site CN86020

Wuhan, Hubei, China

Location

Site CN86001

Beijing, China

Location

Site CN86004

Beijing, China

Location

Site CN86014

Beijing, China

Location

Site CN86010

Chengdu, China

Location

Site CN86009

Guangzhou, China

Location

Site CN86018

Guangzhou, China

Location

Site CN86003

Lanzhou, China

Location

Site CN86013

Shanghai, China

Location

Site CN86002

Suzhou, China

Location

Site CN86021

Taiyuan, China

Location

Site CN86011

Wuhan, China

Location

Site CN86022

Wuxi, China

Location

Site CN86012

Xi'an, China

Location

Site CN86007

Zhengzhou, China

Location

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website
• Link to results and other applicable study documents on the Astellas Clinical Trials website

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Results Point of Contact

• Title: Clinical Transparency
• Organization: Astellas Pharma China, Inc.

astellas.resultsdisclosure@astellas.com

+86-(0)10-85216666

Study Officials

• Executive Director

  Astellas Pharma China, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants fulfilling the screening inclusion/exclusion criteria were randomized in a 2:1 ratio, 50 mg mirabegron and 25 mg mirabegron, using a computer-generated randomization to reduce selection bias.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: January 6, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 30, 2022
• Last Updated: November 15, 2024
• Results First Posted: March 29, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

CN (15)