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

• Status: Recruiting
• Trial end date: 2022-06-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of mirabegron for the treatment of overactive blsdder (OAB) in Chinese participants. This study will also evaluate the safety of mirabegron for the treatment of OAB in Chinese participants, evaluate other efficacy variables of mirabegron for the treatment of OAB and explore different mirabegron starting doses.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• Subject should exhibit symptoms of OAB for at least 12 weeks before initiation of the screening period.

• Subject should have an average of ≥ 8 micturitions/24 hours.

• Subject 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 subject 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 IP administration.

• Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.

• Female subject 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 subject 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 subject must not donate sperm during the treatment period and for 30 days after final IP administration.

• Male subject 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.

• Subject 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)

• Subject has stress urinary incontinence as a predominant symptom.

• Subject has an average total daily urine volume > 3000 mL (as recorded in a 3-day voiding diary period).

• Subject has indwelling catheter or practices intermittent self-catheterization.

• Subject has neurogenic detrusor overactivity or indicated pathology other than OAB.

• Subject as monosymptomatic enuresis.

• Subject has post void residual (PVR) volume of ≥ 100 mL or a clinically significant lower urinary tract obstructive disease, except if successfully treated.

• Subject has anatomical anomalies (surgically treated or untreated) that affect lower urinary tract function.

• Subject 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).

• Subject has lower urinary tract stones or clinically significant kidney stones requiring treatment.

• Subject has interstitial cystitis.

• Subject has suffered from chronic UTI or has had more than 3 ETIs in the 2 months prior to visit 1/week -1 to -2 (screening).

• Subject has uncontrolled hypertension (sitting systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg).

• Subject has pulse rate ≥ 110 beats per minute (bpm) or <50 bpm.

• Subject 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).

• Subject'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 (subjects with Gilbert's syndrome are excepted from the bilirubin threshold).

• Subject has moderate or severe renal impairment.

• Subject 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 subject can be rescreened.

• Subject has a history or presence of any malignancy (previous or current diagnosis of bladder or prostate cancer).

• Subject 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.

• Subject 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), Subject can be included in the study.

• Subject has known or suspected hypersensitivity to mirabegron or any components of the formulations used.

• Subjects previously treated for OAB including medication and nondrug treatment. If the treatment stopped for 2 weeks or more prior to the screening visit, Subjects can be included in the study.

• Subject has participated in another clinical study (and/or subject 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).

• Subject has constipation as defined by the Rome IV criteria that cannot be successfully treated prior to study entry.

• Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.

• Subjects 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.

• Subject is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

• Subject has any condition which makes the subject unsuitable for study participation.

Additional Exclusion at Visit 2/Week 0 (Baseline)

• Subject has stress urinary incontinence as a predominant symptom.

• Subject has an average total daily urine volume > 3000 mL (as recorded in a 3-day voiding diary period).

• Subject has monosymptomatic enuresis confirmed by the bladder e-diary.

• Subject 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).

• Subject 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).

• Subject has uncontrolled hypertension (sitting SBP ≥ 180 mmHg or DBP ≥ 110 mmHg).

• Any reason that makes the subject unsuitable for study participation.