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Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) (PILLAR)

Primary Purpose

Overactive Bladder (OAB)

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Mirabegron

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder (OAB) focused on measuring Urinary Incontinence, Mirabegron, Overactive Bladder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria assessed at Visit 1 (Screening):

Subject is willing and able to complete the micturition diary and questionnaires correctly.
Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.
Subject agrees not to participate in another interventional study from the time of screening until the final study visit.

Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

Subject continues to meet all inclusion criteria of Visit 1.
Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.
Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary.
Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary.

Exclusion Criteria assessed at Visit 1 (Screening):

Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.
Subject has Post-Void Residual Volume (PVR) greater than 150 mL.
Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.
Subject has an indwelling catheter or practices intermittent self-catheterization.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
Subject has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
Subject resides in a nursing home.
Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator.
Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.
Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also not a candidate for the study.
Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.
Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc greater than 450 msec for males, QTc greater than 470 msec for females or a known history of QT prolongation.
Subject has a clinically significant ECG abnormality, as determined by the Investigator.
Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant by the Investigator.
Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists, or any of the inactive ingredients.
Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation.
Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
Subject with current history of alcohol and/or drug abuse.
Subject is using prohibited medications which cannot be stopped safely during the period.
Subject has stopped, started or changed the dose of a restricted medication within the last 30 days prior to Screening.
Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
Subject has previously received mirabegron.

Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]).
Subject was non-compliant during 2-week placebo run-in period, defined as taking less than 80% or greater than 120% of study medication.
Subject has any systolic blood pressure measurement > 180 mmHg or diastolic blood pressure measurement > 110 in the 3-day diary or during the baseline visit.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Mirabegron

Arm Description

Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.

Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.

Outcomes

Primary Outcome Measures

Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions 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.

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 as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.

Secondary Outcome Measures

Change From Baseline to EOT in Mean Volume Voided Per Micturition

The mean volume voided per micturition during 3 days of the 3-day micturition diary period.

Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.

Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score

Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.

Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is 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 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours 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.

Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.

Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.

Change From Baseline to EOT in Barthel Index of Daily Living Score

The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.

Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score

The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.

Change From Baseline to EOT in PPIUS

The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.

Change From Baseline to EOT in OAB-q HRQL Subscale Scores

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).

Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)

The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.

Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.

Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit

The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.

Percentage of Participants Who Achieved Micturition Frequency Normalization

Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.

Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.

Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC

Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC

Number of Participants With Adverse Events (AEs)

Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.

Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score

The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.

Change From Baseline in Post-void Residual Volume (PVR)

PVR was assessed by ultrasonography or bladder scan.

Full Information

NCT ID

NCT02216214

First Posted

August 12, 2014

Last Updated

January 11, 2021

Sponsor

Astellas Pharma Global Development, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02216214

Brief Title

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Acronym

PILLAR

Official Title

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

October 7, 2014 (Actual)

Primary Completion Date

November 29, 2017 (Actual)

Study Completion Date

January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Global Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder (OAB)

Keywords

Urinary Incontinence, Mirabegron, Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

888 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Mirabegron

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mirabegron

Other Intervention Name(s)

YM178, Myrbetriq

Intervention Description

oral tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral tablet

Primary Outcome Measure Information:

Title

Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Secondary Outcome Measure Information:

Title

Change From Baseline to EOT in Mean Volume Voided Per Micturition

Description

The mean volume voided per micturition during 3 days of the 3-day micturition diary period.

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Barthel Index of Daily Living Score

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in PPIUS

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in OAB-q HRQL Subscale Scores

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit

Description

Time Frame

Baseline and Weeks 4, 8 and EOT (up to 12 weeks)

Title

Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Percentage of Participants Who Achieved Micturition Frequency Normalization

Description

Time Frame

End of treatment (up to 12 weeks)

Title

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours

Description

Time Frame

End of treatment (up to 12 weeks)

Title

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours

Description

Time Frame

End of treatment (up to 12 weeks)

Title

Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales

Description

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.

Time Frame

End of treatment (up to 12 weeks)

Title

Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC

Description

Time Frame

End of treatment (up to 12 weeks)

Title

Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC

Description

Time Frame

End of treatment (up to 12 weeks)

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)

Title

Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score

Description

Time Frame

Baseline and EOT (up to 12 weeks)

Title

Change From Baseline in Post-void Residual Volume (PVR)

Description

PVR was assessed by ultrasonography or bladder scan.

Time Frame

Baseline and EOT (up to 12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria assessed at Visit 1 (Screening): Subject is willing and able to complete the micturition diary and questionnaires correctly. Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening. Subject agrees not to participate in another interventional study from the time of screening until the final study visit. Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): Subject continues to meet all inclusion criteria of Visit 1. Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary. Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary. Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary. Exclusion Criteria assessed at Visit 1 (Screening): Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled. Subject has Post-Void Residual Volume (PVR) greater than 150 mL. Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test. Subject has an indwelling catheter or practices intermittent self-catheterization. Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). Subject has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen). Subject resides in a nursing home. Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator. Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin. Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]). Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C. Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also not a candidate for the study. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg. Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc greater than 450 msec for males, QTc greater than 470 msec for females or a known history of QT prolongation. Subject has a clinically significant ECG abnormality, as determined by the Investigator. Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant by the Investigator. Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists, or any of the inactive ingredients. Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation. Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening. Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. Subject with current history of alcohol and/or drug abuse. Subject is using prohibited medications which cannot be stopped safely during the period. Subject has stopped, started or changed the dose of a restricted medication within the last 30 days prior to Screening. Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team. Subject has previously received mirabegron. Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]). Subject was non-compliant during 2-week placebo run-in period, defined as taking less than 80% or greater than 120% of study medication. Subject has any systolic blood pressure measurement > 180 mmHg or diastolic blood pressure measurement > 110 in the 3-day diary or during the baseline visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Global Development, Inc., Medical Affairs, Americas

Official's Role

Study Director

Facility Information:

Facility Name

Site US00066

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Site US00148

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Site US00009

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99503

Country

United States

Facility Name

Site US00020

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Site US00019

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85745

Country

United States

Facility Name

Site US00063

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72120

Country

United States

Facility Name

Site US00081

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Site US00176

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Site US00048

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Site US00142

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

Site US00150

City

Hawaiian Gardens

State/Province

California

ZIP/Postal Code

90716

Country

United States

Facility Name

Site US00112

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Site US00034

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Site US00010

City

Murrieta

State/Province

California

ZIP/Postal Code

92562

Country

United States

Facility Name

Site US00135

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Site US00139

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Site US00144

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Site US00083

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Site US00026

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Site US00039

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Site US00004

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Site US00040

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Site US00090

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Site US00064

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Site US00080

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Site US00002

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

Site US00001

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Site US00017

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Site US00018

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

Site US00027

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Site US00151

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Site US00179

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Site US00057

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34744

Country

United States

Facility Name

Site US00076

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Site US00037

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Site US00029

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Site US00042

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Site US00007

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Site US00021

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

Country

United States

Facility Name

Site US00035

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Site US00075

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Site US00099

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Site US00005

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Site US00041

City

Boise

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Site US00060

City

Greenwood

State/Province

Indiana

ZIP/Postal Code

46143

Country

United States

Facility Name

Site US00046

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

Site US00134

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Site US00104

City

Augusta

State/Province

Kansas

ZIP/Postal Code

67010

Country

United States

Facility Name

Site US00105

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Site US00045

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66202

Country

United States

Facility Name

Site US00172

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Site US00025

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Site US00091

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Site US00006

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Facility Name

Site US00145

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Site US00056

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Site US00003

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Site US00093

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

Country

United States

Facility Name

Site US00024

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Site US00137

City

Sartell

State/Province

Minnesota

ZIP/Postal Code

56377

Country

United States

Facility Name

Site US00159

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Site US00070

City

Norfolk

State/Province

Nebraska

ZIP/Postal Code

68701

Country

United States

Facility Name

Site US00014

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Site US00113

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Facility Name

Site US00111

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Site US00140

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Site US00016

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Site US00043

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Site US00153

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Site US00132

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

Site US00122

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Site US00161

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Site US00165

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Site US00166

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Site US00085

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Site US00067

City

Akron

State/Province

Ohio

ZIP/Postal Code

44313

Country

United States

Facility Name

Site US00050

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Site US00095

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

Site US00084

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Site US00015

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Site US00102

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Site US00103

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Site US00180

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Site US00082

City

Moncks Corner

State/Province

South Carolina

ZIP/Postal Code

29461

Country

United States

Facility Name

Site US00162

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Site US00032

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Site US00154

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Site US00053

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

Facility Name

Site US00052

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37211

Country

United States

Facility Name

Site US00175

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Site US00131

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Site US00174

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

Site US00068

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Site US00071

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Site US00100

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Site US00044

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Site US00036

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Site US00023

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Site US00170

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Site US00086

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Site US00167

City

Seattle

State/Province

Washington

ZIP/Postal Code

98150

Country

United States

Facility Name

Site US00098

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Site US00062

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715

Country

United States

Facility Name

Site CA00130

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5G 0B7

Country

Canada

Facility Name

Site CA00074

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6J1S3

Country

Canada

Facility Name

Site CA00155

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 4S5

Country

Canada

Facility Name

Site CA00123

City

Corunna

State/Province

Ontario

ZIP/Postal Code

N0N1G0

Country

Canada

Facility Name

Site CA00126

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Site CA00118

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Site CA00116

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T4X3

Country

Canada

Facility Name

Site CA00169

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 3Z9

Country

Canada

Facility Name

Site CA00168

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Site CA00164

City

Lévis

State/Province

Quebec

ZIP/Postal Code

G6W 0M6

Country

Canada

Facility Name

Site CA00158

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2Y 1S1

Country

Canada

Facility Name

Site CA00073

City

Point Claire

State/Province

Quebec

ZIP/Postal Code

H9R4S3

Country

Canada

Facility Name

Site CA00106

City

Point Claire

State/Province

Quebec

ZIP/Postal Code

H9R4S3

Country

Canada

Facility Name

Site CA00156

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 1Z1

Country

Canada

Facility Name

Site CA00061

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H5N2

Country

Canada

Facility Name

Site CA00129

City

Quebec

ZIP/Postal Code

G1S2L6

Country

Canada

Facility Name

Site CA00160

City

Quebec

ZIP/Postal Code

G1X 0B6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

32725584

Citation

Herschorn S, Staskin D, Schermer CR, Kristy RM, Wagg A. Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients >/= 65 years with Overactive Bladder-Wet. Drugs Aging. 2020 Sep;37(9):665-676. doi: 10.1007/s40266-020-00783-w.

Results Reference

derived

PubMed Identifier

32183741

Citation

Griebling TL, Campbell NL, Mangel J, Staskin D, Herschorn S, Elsouda D, Schermer CR. Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR). BMC Geriatr. 2020 Mar 18;20(1):109. doi: 10.1186/s12877-020-1474-7.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=301

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

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Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) (PILLAR)

Overactive Bladder (OAB)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial