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

NCT ID: NCT04562090

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2022-03-30

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.

Detailed Description

The study followed an open-label, randomized, 12-week, prospective, interventional post-authorization design for the treatment of OAB in 249 Chinese participants. Each eligible participant took part in a 12-week treatment period. Treatments were administered once daily orally after a meal during a 12-week, open-label treatment period. Study visits took place at weeks 4, 8 and 12. For the 25 mg mirabegron group, a dose escalation to 50 mg was permitted on visit 3 and visit 4 at the investigators' discretion. 15 study sites across China enrolled participants.

Conditions

Urge Incontinence; Overactive Bladder (OAB)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mirabegron 25 mg

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.

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

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

Mirabegron 50 mg

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.

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

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

Interventions

mirabegron

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

Intervention Type: DRUG

Other Intervention Names

Betmiga

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

Exclusion at Visit 1/Week -2 (Screening)

• 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).
• Participant has moderate or severe renal impairment.
• Participant has a symptomatic (symptoms can include pain, fever, hematuria, new onset foul-smelling urine) UTI. Note: if the UTI is treated successfully (clinical recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both should be negative]), the participant can be rescreened.
• Participant has a history or presence of any malignancy (previous or current diagnosis of bladder or prostate cancer).
• Participant uses any drugs that are sensitive cytochrome P450 2D6 (CYP2D6) substrates with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates after the start of washout.
• Participant is using or has used prohibited prior and/or concomitant medication(s). In case α1-AR antagonists, 5α-reductase inhibitors (5-ARIs) and Phosphodiesterase type 5 inhibitors (PED-Is) are used for Benign Prostatic Hyperplasia(BPH), participant can be included in the study.
• Participant has known or suspected hypersensitivity to mirabegron or any components of the formulations used.
• Participants previously treated for OAB including medication and nondrug treatment. If the treatment stopped for 2 weeks or more prior to the screening visit, participants can be included in the study.
• Participant has participated in another clinical study (and/or participant has received any investigational therapy within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/week -1 to -2 (screening).
• Participant has constipation as defined by the Rome IV criteria that cannot be successfully treated prior to study entry.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participants has a positive serology test for hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM]), hepatitis B core (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, antibodies to human immunodeficiency virus (HIV) or syphilis at screening.
• Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
• Participant has any condition which makes the participant unsuitable for study participation.

Additional Exclusion at Visit 2/Week 0 (Baseline)

• 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 monosymptomatic enuresis confirmed by the bladder e-diary.
• Participant suffers from a symptomatic (symptoms can include pain, fever, hematuria, new onset foul-smelling urine) UTI. Note: if a symptomatic UTI is present, all visit 2/week 0 (baseline) assessments must be postponed until the UTI is successfully treated (clinical recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both should be negative]). The postponed visit 2/week 0 (baseline) should be within 14 days of the intended visit 2/week 0 (baseline).
• 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 uncontrolled hypertension (sitting SBP ≥ 180 mmHg or DBP ≥ 110 mmHg).
• Any reason that makes the participant unsuitable for study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Executive Director

Role: STUDY_DIRECTOR

Astellas Pharma China, Inc.

Locations

Site CN86020

Wuhan, Hubei, China

Site CN86001

Beijing, , China

Site CN86004

Beijing, , China

Site CN86014

Beijing, , China

Site CN86010

Chengdu, , China

Site CN86009

Guangzhou, , China

Site CN86018

Guangzhou, , China

Site CN86003

Lanzhou, , China

Site CN86013

Shanghai, , China

Site CN86002

Suzhou, , China

Site CN86021

Taiyuan, , China

Site CN86011

Wuhan, , China

Site CN86022

Wuxi, , China

Site CN86012

Xi'an, , China

Site CN86007

Zhengzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=15079&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website

https://www.clinicaltrials.astellas.com/study/178-MA-2295/

Link to results and other applicable study documents on the Astellas Clinical Trials website

Other Identifiers

CTR20202160

Identifier Type: REGISTRY

Identifier Source: secondary_id

178-MA-2295

Identifier Type: -

Identifier Source: org_study_id