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)
A Phase 4, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Mirabegron in Japanese and Korean Male Patients With Overactive Bladder Under Treatment With the α-Blocker Tamsulosin for Benign Prostatic Hyperplasia
1 other identifier
interventional
568
2 countries
58
Brief Summary
The primary objective of the study was to investigate the efficacy of mirabegron versus placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for BPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2016
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedStudy Start
First participant enrolled
January 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2017
CompletedResults Posted
Study results publicly available
September 18, 2018
CompletedNovember 12, 2024
October 1, 2024
1.5 years
January 13, 2016
July 9, 2018
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Baseline and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Baseline and week 4, 8 and 12
Secondary Outcomes (14)
Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Nocturia Episodes
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Baseline and EoT (up to 12 weeks)
- +9 more secondary outcomes
Study Arms (2)
Mirabegron 50 mg
EXPERIMENTALParticipants who received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks
Placebo
EXPERIMENTALParticipants who received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 \<5 mL/sec.
- Patient with prostate-specific antigen (PSA) ≥4 ng/mL.
- Patient with neurogenic bladder (e.g., spinal-cord lesions or other damage that will clearly affect urination; multiple sclerosis; Parkinson's disease) or a history of surgery that caused damage to the pelvic plexus.
- Patient with urethral stricture or bladder-neck stenosis.
- Patient with diabetic neuropathy complications.
- Patient who had undergone a surgical procedure, previous pelvic radiation therapy, or hyperthermia therapy that may affect urinary tract function.
- Patient with significant stress incontinence or postsurgical prostate incontinence, as determined by the Investigator.
- Patient with an indwelling catheter or practices intermittent self-catheterization.
- Patient with 3 or more episodes of recurrent urinary tract infection (UTI) within the last 6 months.
- Patient with a UTI; prostatitis; chronic inflammation, such as interstitial cystitis; urinary calculus; or previous or current malignant disease of the pelvic organs.
- Patient with a concurrent malignancy or history of any malignancy (within the past 5 years), except for non-metastatic basal-cell or squamous-cell carcinoma of the skin that had been treated successfully.
- Patient with serious heart disease, liver disease, kidney disease, immunological disease, lung disease.
- Patient who had received intravesical injection within the last 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma Singapore Pte. Ltd.collaborator
Study Sites (58)
Site JP81046
Aichi, Japan
Site JP81009
Chiba, Japan
Site JP81045
Chiba, Japan
Site JP81041
Fukuoka, Japan
Site JP81042
Fukuoka, Japan
Site JP81043
Fukuoka, Japan
Site JP81044
Fukuoka, Japan
Site JP81048
Fukuoka, Japan
Site JP81004
Gunma, Japan
Site JP81005
Gunma, Japan
Site JP81001
Hokkaido, Japan
Site JP81002
Hokkaido, Japan
Site JP81003
Hokkaido, Japan
Site JP81038
Hyōgo, Japan
Site JP81039
Hyōgo, Japan
Site JP81040
Hyōgo, Japan
Site JP81024
Kanagawa, Japan
Site JP81056
Kanagawa, Japan
Site JP81051
Kochi, Japan
Site JP81052
Kochi, Japan
Site JP81047
Kumamoto, Japan
Site JP81025
Osaka, Japan
Site JP81026
Osaka, Japan
Site JP81027
Osaka, Japan
Site JP81028
Osaka, Japan
Site JP81029
Osaka, Japan
Site JP81030
Osaka, Japan
Site JP81031
Osaka, Japan
Site JP81032
Osaka, Japan
Site JP81033
Osaka, Japan
Site JP81034
Osaka, Japan
Site JP81035
Osaka, Japan
Site JP81036
Osaka, Japan
Site JP81037
Osaka, Japan
Site JP81053
Osaka, Japan
Site JP81054
Osaka, Japan
Site JP81006
Saitama, Japan
Site JP81007
Saitama, Japan
Site JP81008
Saitama, Japan
Site JP81050
Shizuoka, Japan
Site JP81010
Tokyo, Japan
Site JP81011
Tokyo, Japan
Site JP81012
Tokyo, Japan
Site JP81013
Tokyo, Japan
Site JP81014
Tokyo, Japan
Site JP81015
Tokyo, Japan
Site JP81016
Tokyo, Japan
Site JP81017
Tokyo, Japan
Site JP81018
Tokyo, Japan
Site JP81019
Tokyo, Japan
Site JP81020
Tokyo, Japan
Site JP81021
Tokyo, Japan
Site JP81022
Tokyo, Japan
Site KR00001
Seoul, South Korea
Site KR00002
Seoul, South Korea
Site KR00003
Seoul, South Korea
Site KR00004
Seoul, South Korea
Site KR00005
Seoul, South Korea
Related Publications (1)
Kakizaki H, Lee KS, Katou D, Yamamoto O, Sumarsono B, Uno S, Yamaguchi O. Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study. Adv Ther. 2021 Jan;38(1):739-757. doi: 10.1007/s12325-020-01517-5. Epub 2020 Nov 27.
PMID: 33245533DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Astellas Pharma Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 14, 2016
Study Start
January 25, 2016
Primary Completion
July 21, 2017
Study Completion
July 21, 2017
Last Updated
November 12, 2024
Results First Posted
September 18, 2018
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.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.