Overactive BladderPhase 4NCT02656173
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 study testing Mirabegron and Tamsulosin in people with Overactive Bladder, run by Astellas Pharma Inc at 58 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Mirabegron and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 568 participants
- Where
- 58 sitesin 2 countries
- Study dates
- 25 Jan 2016to 21 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 36Show fewer
- 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.
- Patient who had received electrostimulation therapy for OAB.
- Patient who had received a bladder training program or pelvic floor exercises <28 days prior to the start of the Screening period.
- Patient with postural hypotension or syncope, hypokalemia, or closed-angle glaucoma.
- Patient with evidence of QT prolongation on electrocardiogram (ECG), defined as QTcF >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 <29 mL/min/1.73m2; end-stage renal disease; or is undergoing dialysis.
- Patient with aspartate transaminase (AST) or alanine transaminase (ALT) >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 <84 days or received an investigational agent <84 days prior to the start of the Screening period.
- Patient had used any prohibited concomitant medication <28 days (but, <1 year for 5α-reductase inhibitors) before the start of the Screening period.
- Patient with any clinically significant condition, which in the opinion of the Investigator, made the subject unsuitable for study participation.
- Patient who was involved in the conduct of the study as an employee of the Astellas group, a third party associated with the study, or the study site team.
- at Visit 2 (Baseline):
- Subject fulfills any exclusion criteria of Visit 1 at Visit 2.
- Subject was noncompliant during the 4 week tamsulosin Screening period, defined as taking less than 80% or greater than 120% of prescribed dose of study medication.
- Subject had an average total daily urine volume >3000 mL, as recorded in the 3-day micturition diary.
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
Japan53 sites
Site JP81046
Aichi
Site JP81009
Chiba
Site JP81045
Chiba
Site JP81041
Fukuoka
Site JP81042
Fukuoka
Site JP81043
Fukuoka
Site JP81044
Fukuoka
Site JP81048
Fukuoka
Site JP81004
Gunma
Site JP81005
Gunma
Site JP81001
Hokkaido
Site JP81002
Hokkaido
Site JP81003
Hokkaido
Site JP81038
Hyōgo
Site JP81039
Hyōgo
Site JP81040
Hyōgo
Site JP81024
Kanagawa
Site JP81056
Kanagawa
Site JP81051
Kochi
Site JP81052
Kochi
Site JP81047
Kumamoto
Site JP81025
Osaka
Site JP81026
Osaka
Site JP81027
Osaka
Site JP81028
Osaka
Site JP81029
Osaka
Site JP81030
Osaka
Site JP81031
Osaka
Site JP81032
Osaka
Site JP81033
Osaka
Site JP81034
Osaka
Site JP81035
Osaka
Site JP81036
Osaka
Site JP81037
Osaka
Site JP81053
Osaka
Site JP81054
Osaka
Site JP81006
Saitama
Site JP81007
Saitama
Site JP81008
Saitama
Site JP81050
Shizuoka
Site JP81010
Tokyo
Site JP81011
Tokyo
Site JP81012
Tokyo
Site JP81013
Tokyo
Site JP81014
Tokyo
Site JP81015
Tokyo
Site JP81016
Tokyo
Site JP81017
Tokyo
Site JP81018
Tokyo
Site JP81019
Tokyo
Site JP81020
Tokyo
Site JP81021
Tokyo
Site JP81022
Tokyo
South Korea5 sites
Site KR00001
Seoul
Site KR00002
Seoul
Site KR00003
Seoul
Site KR00004
Seoul
Site KR00005
Seoul
About this study
Official title: 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
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.
- Conditions
- Overactive Bladder
- Being tested
- Mirabegron, Placebo, Tamsulosin
- Keywords
- Tamsulosin, Overactive bladder, Benign prostatic hypertrophy, Mirabegron
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called YM178
Oral tablet
PlaceboDrug
Oral tablet
TamsulosinDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron 50 mg | Experimental | Participants who received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks Receives: Drug: Mirabegron; Drug: Tamsulosin |
| Placebo | Experimental | Participants who received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks. Receives: Drug: Placebo; Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and week 4, 8 and 12
Secondary outcomes (14)
Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Nocturia Episodes
A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in OABSS Subscale Scores
Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency ("How many times do you typically urinate from waking in the morning until sleeping at night?" where scores range from 0-2), Nighttime Frequency ("How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" where scores range from 0-3), Urgency ("How often do you have a sudden desire to urinate, which is difficult to defer?" where scores range from 0-5), Urgency Incontinence ("How often do you leak urine because you cannot defer the sudden desire to urinate?" where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in IPSS Subscale Scores
IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.
Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q
The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.
Total HRQL score was derived as sum of HRQL subscale scores (range: 25-150). Higher total HRQL score is indicative of better HRQL.
Measured: Baseline and EoT (up to 12 weeks)
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.
Measured: From first dose of study drug up to Week 12
Change From Baseline to EoT in Postvoid Residual (PVR) Volume
PVR was measured by ultrasonography.
Measured: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time).
Measured: Baseline and EoT (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start25 Jan 2016
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Singapore Pte. Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656173
- Sponsor's protocol ID
- 178-MA-3016
- Status last verified
- Oct 2024
- First submitted
- 13 Jan 2016
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 33245533
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02656173
- Acronym / sponsor ID
- 178-MA-3016
- Conditions
- Overactive Bladder
- Keywords
- Tamsulosin, Overactive bladder, Benign prostatic hypertrophy, Mirabegron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Singapore Pte. Ltd.
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 18 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron 50 mg | Experimental | Drug: Mirabegron, Drug: TamsulosinParticipants who received mirabegron 50 mg once a day along with tamsulosin 0.2 mg for 12 weeks |
| Placebo | Experimental | Drug: Placebo, Drug: TamsulosinParticipants who received matching placebo once a day along with tamsulosin 0.2 mg for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: YM178Oral tablet | Drug | Mirabegron 50 mg |
| PlaceboOral tablet | Drug | Placebo |
| TamsulosinOral tablet | Drug | Mirabegron 50 mg, Placebo |
Primary outcome
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and EoT (up to 12 weeks)
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.
Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and week 4, 8 and 12
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.
14 secondary outcomes
Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Nocturia Episodes
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in OABSS Subscale Scores
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in IPSS Subscale Scores
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q
Time frame: Baseline and EoT (up to 12 weeks)
Number of Participants With Adverse Events
Time frame: From first dose of study drug up to Week 12
Change From Baseline to EoT in Postvoid Residual (PVR) Volume
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
Time frame: Baseline and EoT (up to 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33245533Kakizaki 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron and Tamsulosin in people with Overactive Bladder, run by Astellas Pharma Inc at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours (time frame: Baseline and EoT (up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.