A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)

Inclusion Criteria

at Visit 1 (Screening):

• Patient had been under treatment with tamsulosin 0.2mg for at least 4 weeks before the start of the Screening period.
• Patient with a history of an average of at least 2 episodes of urgency per 24 hours and an average of 8 or more micturitions per 24 hours during the last 3 days before the start of the Screening period (verified by interview).
• Patient who had no wish to have children in the future (Unique to Japan).
• Male subjects and their female spouses/partners who were of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method), starting at Screening, continuing throughout the study period, and for 28 days after the final study drug administration.
• Subject must not donate sperm, starting at Screening, continuing throughout the study period, and for 28 days after the final study drug administration.
• Patient was willing and able to complete the micturition diary and questionnaires correctly.
• Subject agreed not to participate in another interventional study while receiving treatment in this study.

at Visit 2 (Baseline):

• Subject with an average of at least 2 episodes of urgency per 24 hours and an average of 8 or more micturitions per 24 hours based on a 3-day micturition diary from the Screening period.

Exclusion Criteria

at Visit 1 (Screening):

• Patient with suspected symptoms of OAB, with onset only transient (e.g., drug-induced, psychogenic).
• Patient with PVR urine volume >100 mL or Q max 450 msec.
• Patient with severe uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) >180 mmHg and/or diastolic blood pressure (DBP) >110 mmHg.
• Patient with a clinically significant ECG abnormality, as determined by the Investigator.
• Patient who had severe renal impairment, defined as an estimated glomerular filtration rate of 2 times the upper limit of normal (ULN), or gamma-glutamyl transferase (γ-GT) >3 times the ULN and considered clinically significant by the Investigator.
• Patient with moderate or severe hepatic impairment, defined as Child-Pugh Class B or C.
• Patient with hypersensitivity to any of the components of mirabegron, other beta-adrenergic receptor (β-AR) agonists, or any of the inactive ingredients.
• Patient with ongoing alcohol and/or drug abuse.
• Patient with or a history of mood disorder, neurotic disorder, or schizophrenia.
• Patient with dementia, cognitive dysfunction, or clinically significant cerebrovascular disorder.
• Patient who had been treated with an experimental device 3000 mL, as recorded in the 3-day micturition diary.