Urge IncontinencePhase 4NCT04562090
A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder
A Phase 4 study testing mirabegron in people with Urge Incontinence and Overactive Bladder (OAB), run by Astellas Pharma China, Inc. at 15 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urge Incontinence, Overactive Bladder (OAB)
- What is being tested?
- mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 15 sitesChina
- Study dates
- 6 Jan 2021to 30 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Site CN86001
Beijing
Site CN86004
Beijing
Site CN86014
Beijing
Site CN86010
Chengdu
Site CN86009
Guangzhou
Site CN86018
Guangzhou
Site CN86003
Lanzhou
Site CN86013
Shanghai
Site CN86002
Suzhou
Site CN86021
Taiyuan
Site CN86020
Wuhan, Hubei
Site CN86011
Wuhan
Site CN86022
Wuxi
Site CN86012
Xi'an
Site CN86007
Zhengzhou
About this study
Official title: A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects
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.
Read the 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)
- Being tested
- mirabegron
- Keywords
- mirabegron
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called Betmiga
Mirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron 25 mg | Experimental | 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. Receives: Drug: mirabegron |
| Mirabegron 50 mg | Experimental | 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. Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Measured: Baseline, week 12
Secondary outcomes (8)
Number of Participants With Treatment Emergent Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug.
Measured: From first dose up to 30 days after last dose (up to week 16)
Change From Baseline to Week 12 in Post Void Residual (PVR) Volume
PVR was assessed by ultrasonography.
Measured: Baseline, week 12
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in OAB Symptom Score (OABSS)
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: 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). The total score ranges from 0 to 15 with higher score indicating more symptoms.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Micturition Per 24 Hours
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Measured: Baseline and weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start6 Jan 2021
- Primary completion17 Mar 2022
- Study completion30 Mar 2022
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.
- Other trials for Urge IncontinenceStudies 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
- Model description
- Participants fulfilling the screening inclusion/exclusion criteria were randomized in a 2:1 ratio, 50 mg mirabegron and 25 mg mirabegron, using a computer-generated randomization to reduce selection bias.
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Director, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562090
- Sponsor's protocol ID
- 178-MA-2295
- Other IDs
- CTR20202160
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2020
- Last updated
- 15 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/.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects
- ClinicalTrials.gov ID
- NCT04562090
- Acronym / sponsor ID
- 178-MA-2295
- Conditions
- Urge Incontinence, Overactive Bladder (OAB)
- Keywords
- mirabegron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants fulfilling the screening inclusion/exclusion criteria were randomized in a 2:1 ratio, 50 mg mirabegron and 25 mg mirabegron, using a computer-generated randomization to reduce selection bias.
| Arm | Type | Receives |
|---|---|---|
| Mirabegron 25 mg | Experimental | Drug: mirabegronParticipants 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. |
| Mirabegron 50 mg | Experimental | Drug: mirabegronParticipants received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
Key exclusion criteria (36 listed)
- 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.
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: BetmigaMirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet | Drug | Mirabegron 25 mg, Mirabegron 50 mg |
Primary outcome
Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group
Time frame: Baseline, week 12
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
8 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events
Time frame: From first dose up to 30 days after last dose (up to week 16)
Change From Baseline to Week 12 in Post Void Residual (PVR) Volume
Time frame: Baseline, week 12
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Time frame: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Time frame: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Time frame: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
Time frame: Baseline and weeks 4, 8, and 12
Change From Baseline in OAB Symptom Score (OABSS)
Time frame: Baseline and weeks 4, 8, and 12
Change From Baseline in Mean Number of Micturition Per 24 Hours
Time frame: Baseline and weeks 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- 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.
Executive Director study director
Astellas Pharma China, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirabegron in people with Urge Incontinence and Overactive Bladder (OAB), run by Astellas Pharma China, Inc. at 15 sites in China.
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 12 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 15 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 15 sites in China. 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 29 Mar 2023). 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 (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group (time frame: Baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.