Back to results

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. (BEYOND)

Primary Purpose

Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Mirabegron

Solifenacin succinate

About this trial

This is an interventional treatment trial for Urologic Diseases focused on measuring Vesitrim, Frequency, Urgency, Urgency incontinence, Urinary incontinence, Overactive Bladder (OAB), Micturition, Mirabegron, YM178, Vesicare, Solifenacin

Eligibility Criteria

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

Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly
Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
Subject has neurogenic bladder
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)
Subject has an indwelling catheter or practices intermittent self-catheterization
Subject has diabetic neuropathy
Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
Subject has moderate to severe hepatic impairment
Subject has severe renal impairment or end stage renal disease
Subject has severe uncontrolled hypertension
Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
Subject's last antimuscarinic treatment was solifenacin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirabegron 50 mg

Solifenacin 5 mg

Arm Description

Participants who received mirabegron 50 mg once daily for 12 weeks.

Participants who received solifenacin 5 mg once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Secondary Outcome Measures

Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours

Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.

Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment

The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.

Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.

Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.

Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).

Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).

Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 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 indicates an improvement.

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q

The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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.

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?" and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?" with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).

Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.

Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.

Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.

Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.

Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.

Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.

Full Information

NCT ID

NCT01638000

First Posted

July 9, 2012

Last Updated

November 20, 2017

Sponsor

Astellas Pharma Europe Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01638000

Brief Title

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

Acronym

BEYOND

Official Title

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

June 12, 2012 (Actual)

Primary Completion Date

April 24, 2013 (Actual)

Study Completion Date

April 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Europe Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

6. Conditions and Keywords

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

Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases

Keywords

Vesitrim, Frequency, Urgency, Urgency incontinence, Urinary incontinence, Overactive Bladder (OAB), Micturition, Mirabegron, YM178, Vesicare, Solifenacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1887 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mirabegron 50 mg

Arm Type

Experimental

Arm Description

Participants who received mirabegron 50 mg once daily for 12 weeks.

Arm Title

Solifenacin 5 mg

Arm Type

Active Comparator

Arm Description

Participants who received solifenacin 5 mg once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Mirabegron

Other Intervention Name(s)

Betanis, YM178, Myrbetriq, Betmiga

Intervention Description

oral tablet

Intervention Type

Drug

Intervention Name(s)

Solifenacin succinate

Other Intervention Name(s)

Vesicare, YM905, Vesikur, Vesitrim

Intervention Description

oral tablet

Primary Outcome Measure Information:

Title

Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

Description

Time Frame

Baseline and final visit (up to Week 12)

Secondary Outcome Measure Information:

Title

Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

Description

Time Frame

From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)

Title

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

Description

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

Description

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

Description

The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment

Description

The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time Frame

Baseline and Week 4, Week 8 , Week 12

Title

Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

Description

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment

Description

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

Description

Time Frame

Week 4, Week 8, Week 12

Title

Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

Description

A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.

Time Frame

Week 4, Week 8, Week 12

Title

Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

Description

A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and final visit (up to Week 12)

Title

Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and final visit (up to Week 12)

Title

Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and final visit (up to Week 12)

Title

Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and final visit (up to Week 12)

Title

Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

Description

Time Frame

Baseline and final visit (up to Week 12)

Title

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

Description

Time Frame

Baseline and Week 4, Week 8, Week 12

Title

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

Description

A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.

Time Frame

Baseline to Week 12

Title

Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

Description

A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.

Time Frame

Baseline to Week 12

Title

Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

Description

A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.

Time Frame

Baseline to Week 12

Title

Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

Description

A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.

Time Frame

Baseline to final visit (up to Week 12)

Title

Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

Description

A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.

Time Frame

Baseline to Week 12

Title

Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

Description

A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.

Time Frame

Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is willing and able to complete the micturition diary and questionnaires correctly Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit Exclusion Criteria: Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control Subject has neurogenic bladder 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) Subject has an indwelling catheter or practices intermittent self-catheterization Subject has diabetic neuropathy Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening) Subject has moderate to severe hepatic impairment Subject has severe renal impairment or end stage renal disease Subject has severe uncontrolled hypertension Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria Subject's last antimuscarinic treatment was solifenacin

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Study Manager

Organizational Affiliation

Astellas Pharma Europe Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Site: 37406

City

Yerevan

ZIP/Postal Code

0001

Country

Armenia

Facility Name

Site: 37404

City

Yerevan

ZIP/Postal Code

0014

Country

Armenia

Facility Name

Site: 37403

City

Yerevan

ZIP/Postal Code

0052

Country

Armenia

Facility Name

Site: 37401

City

Yerevan

ZIP/Postal Code

0078

Country

Armenia

Facility Name

Site: 37402

City

Yerevan

ZIP/Postal Code

0078

Country

Armenia

Facility Name

Site: 43006

City

Baden

ZIP/Postal Code

2500

Country

Austria

Facility Name

Site: 43014

City

Graz

ZIP/Postal Code

9036

Country

Austria

Facility Name

Site: 43015

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Site: 43013

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Site: 43005

City

Oberwart

ZIP/Postal Code

7400

Country

Austria

Facility Name

Site: 43011

City

Vienna

ZIP/Postal Code

1020

Country

Austria

Facility Name

Site: 43002

City

Vienna

ZIP/Postal Code

1220

Country

Austria

Facility Name

Site: 43003

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Site: 37502

City

Minsk

ZIP/Postal Code

220119

Country

Belarus

Facility Name

Site: 37501

City

Minsk

ZIP/Postal Code

223041

Country

Belarus

Facility Name

Site: 37504

City

Vitebsk

ZIP/Postal Code

210037

Country

Belarus

Facility Name

Site: 32006

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Site: 32008

City

Deurne

ZIP/Postal Code

2100

Country

Belgium

Facility Name

Site: 32001

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Site: 32004

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Site: 32007

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Site: 32005

City

Liege

Country

Belgium

Facility Name

Site: 35902

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Site: 35909

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

Site: 35901

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Site: 35905

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

Site: 35906

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Site: 35908

City

Sofia

ZIP/Postal Code

1504

Country

Bulgaria

Facility Name

Site: 35903

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Site: 10010

City

Abbotsford

ZIP/Postal Code

V2S 3N5

Country

Canada

Facility Name

Site: 10011

City

Barrie

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Site: 10001

City

Bathurst

ZIP/Postal Code

E2A 4Z2

Country

Canada

Facility Name

Site: 10003

City

Brampton

ZIP/Postal Code

L6T 4S5

Country

Canada

Facility Name

Site: 10005

City

Brantford

ZIP/Postal Code

N3R 4N3

Country

Canada

Facility Name

Site: 10007

City

Kingston

ZIP/Postal Code

K7L 3J7

Country

Canada

Facility Name

Site: 10002

City

Montreal

ZIP/Postal Code

H4N 3C5

Country

Canada

Facility Name

Site: 10009

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Site: 10004

City

Toronto

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Site: 10008

City

Victoria

ZIP/Postal Code

V8V 3N1

Country

Canada

Facility Name

Site: 42004

City

Bohumin

ZIP/Postal Code

73581

Country

Czechia

Facility Name

Site: 42003

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Site: 42001

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Site: 42002

City

Jihlava

ZIP/Postal Code

586 33

Country

Czechia

Facility Name

Site: 42006

City

Plzen-Lochotin

ZIP/Postal Code

30460

Country

Czechia

Facility Name

Site: 42005

City

Prague 1

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Site: 42007

City

Prague 4

ZIP/Postal Code

14000

Country

Czechia

Facility Name

Site: 42008

City

Prague

ZIP/Postal Code

128 51

Country

Czechia

Facility Name

Site: 45002

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Site: 45001

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Site: 45005

City

Frederiksbjerg

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Site: 45004

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Site: 45003

City

Odense C

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Site: 35802

City

Jyvaskyla

ZIP/Postal Code

40620

Country

Finland

Facility Name

Site: 35801

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

Site: 35804

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Site: 33010

City

Angers

ZIP/Postal Code

49033

Country

France

Facility Name

Site: 33007

City

Colmar Cedex

ZIP/Postal Code

68024

Country

France

Facility Name

Site: 33011

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Site: 33002

City

Marseille

ZIP/Postal Code

13285

Country

France

Facility Name

Site: 33006

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Site: 33013

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Site: 33004

City

Orleans Cedex 2

ZIP/Postal Code

45067

Country

France

Facility Name

Site: 33001

City

Paris Cedex 20

ZIP/Postal Code

75970

Country

France

Facility Name

Site: 33005

City

Paris Cedex 20

ZIP/Postal Code

75970

Country

France

Facility Name

Site: 33003

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Site: 33014

City

Suresnes Cedex

ZIP/Postal Code

92151

Country

France

Facility Name

Site: 33017

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Site: 33015

City

Valence

ZIP/Postal Code

26953

Country

France

Facility Name

Site: 99501

City

Tbilisi

ZIP/Postal Code

144

Country

Georgia

Facility Name

Site: 99502

City

Tbilisi

ZIP/Postal Code

159

Country

Georgia

Facility Name

Site: 99503

City

Tbilisi

ZIP/Postal Code

159

Country

Georgia

Facility Name

Site: 49006

City

Bad Ems

ZIP/Postal Code

56130

Country

Germany

Facility Name

Site: 49009

City

Halle Saale

ZIP/Postal Code

06132

Country

Germany

Facility Name

Site: 30005

City

Alexandroupoli

ZIP/Postal Code

68100

Country

Greece

Facility Name

Site: 30009

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Site: 30007

City

Athens

ZIP/Postal Code

166 73

Country

Greece

Facility Name

Site: 30001

City

Athens

Country

Greece

Facility Name

Site: 30006

City

Herakleion

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Site: 30008

City

Larisa

ZIP/Postal Code

41334

Country

Greece

Facility Name

Site: 30004

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Site: 30010

City

Thessaloniki

ZIP/Postal Code

546 42

Country

Greece

Facility Name

Site: 30002

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Site: 36003

City

Budapest

ZIP/Postal Code

1082

Country

Hungary

Facility Name

Site: 36004

City

Budapest

ZIP/Postal Code

1237

Country

Hungary

Facility Name

Site: 36005

City

Csongrad

ZIP/Postal Code

H-6640

Country

Hungary

Facility Name

Site: 36006

City

Nyiregyhaza

ZIP/Postal Code

H-4400

Country

Hungary

Facility Name

Site: 36001

City

Salgotarjan

ZIP/Postal Code

3100

Country

Hungary

Facility Name

Site: 36002

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Site: 35304

City

Cork

Country

Ireland

Facility Name

Site: 35302

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Site: 35306

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Site: 35301

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Site: 35303

City

Tralee

Country

Ireland

Facility Name

Site: 35305

City

Waterford

Country

Ireland

Facility Name

Site: 39001

City

Avellino

ZIP/Postal Code

83100

Country

Italy

Facility Name

Site: 39005

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Site: 39003

City

Cinisello Balsamo

ZIP/Postal Code

20092

Country

Italy

Facility Name

Site: 39002

City

Florence

ZIP/Postal Code

50139

Country

Italy

Facility Name

Site: 39008

City

Milan

ZIP/Postal Code

20153

Country

Italy

Facility Name

Site: 39010

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Site: 39006

City

Perugia

ZIP/Postal Code

06156

Country

Italy

Facility Name

Site: 39007

City

Treviglio

ZIP/Postal Code

24047

Country

Italy

Facility Name

Site: 77705

City

Almaty

ZIP/Postal Code

050060

Country

Kazakhstan

Facility Name

Site: 77706

City

Almaty

ZIP/Postal Code

50091

Country

Kazakhstan

Facility Name

Site: 77703

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

Facility Name

Site: 77702

City

Astana

ZIP/Postal Code

10000

Country

Kazakhstan

Facility Name

Site: 37103

City

Liepaja

ZIP/Postal Code

LV-3401

Country

Latvia

Facility Name

Site: 37102

City

Riga

ZIP/Postal Code

1038

Country

Latvia

Facility Name

Site: 37101

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Site: 96103

City

Achrafieh

Country

Lebanon

Facility Name

Site: 96102

City

Jbeil

Country

Lebanon

Facility Name

Site: 37001

City

Kaunas

ZIP/Postal Code

50219

Country

Lithuania

Facility Name

Site: 37003

City

Vilnius

ZIP/Postal Code

LT-01118

Country

Lithuania

Facility Name

Site: 31010

City

Amsterdam

Country

Netherlands

Facility Name

Site: 31005

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Site: 31004

City

Enschede

ZIP/Postal Code

7511 JX

Country

Netherlands

Facility Name

Site: 31007

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Site: 31001

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Site: 31008

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Site: 31006

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Site: 47002

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Site: 47001

City

Tonsberg

ZIP/Postal Code

3103

Country

Norway

Facility Name

Site: 47005

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Site: 48007

City

Kolbuszowa Dolna

ZIP/Postal Code

36-100

Country

Poland

Facility Name

Site: 48006

City

Krakow

ZIP/Postal Code

31-315

Country

Poland

Facility Name

Site: 48001

City

Lublin

ZIP/Postal Code

20-632

Country

Poland

Facility Name

Site: 48004

City

Piaseczno

ZIP/Postal Code

05-500

Country

Poland

Facility Name

Site: 48003

City

Warsaw

ZIP/Postal Code

02-929

Country

Poland

Facility Name

Site: 48005

City

Wroclaw

ZIP/Postal Code

01-432

Country

Poland

Facility Name

Site: 35105

City

Lisbon

ZIP/Postal Code

1050-199

Country

Portugal

Facility Name

Site: 35104

City

Lisbon

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Site: 35102

City

Matosinhos

ZIP/Postal Code

4454-509

Country

Portugal

Facility Name

Site: 35103

City

Porto

ZIP/Postal Code

4100-180

Country

Portugal

Facility Name

Site: 35101

City

Setubal

ZIP/Postal Code

2910-446

Country

Portugal

Facility Name

Site: 70007

City

Moscow

ZIP/Postal Code

101000

Country

Russian Federation

Facility Name

Site: 70001

City

Moscow

ZIP/Postal Code

105425

Country

Russian Federation

Facility Name

Site: 70008

City

Moscow

ZIP/Postal Code

115516

Country

Russian Federation

Facility Name

Site: 70005

City

Moscow

ZIP/Postal Code

117815

Country

Russian Federation

Facility Name

Site: 70006

City

Moscow

ZIP/Postal Code

117815

Country

Russian Federation

Facility Name

Site: 70011

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Site: 70002

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Site: 70003

City

Moscow

ZIP/Postal Code

125206

Country

Russian Federation

Facility Name

Site: 70013

City

Saint Petersburg

ZIP/Postal Code

194175

Country

Russian Federation

Facility Name

Site: 70012

City

Saint Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Site: 70010

City

Saint Petersburg

ZIP/Postal Code

198103

Country

Russian Federation

Facility Name

Site: 70009

City

Saint Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Site: 70004

City

St. Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Site: 42104

City

Galanta

ZIP/Postal Code

924 22

Country

Slovakia

Facility Name

Site: 42106

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Site: 42103

City

Piestany

ZIP/Postal Code

92102

Country

Slovakia

Facility Name

Site: 42101

City

Poprad

ZIP/Postal Code

05801

Country

Slovakia

Facility Name

Site: 42105

City

Trencin

ZIP/Postal Code

911 01

Country

Slovakia

Facility Name

Site: 42102

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Site: 38603

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Site: 38604

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Site: 38601

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Site: 38602

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Site: 38606

City

Novo Mesto

ZIP/Postal Code

8000

Country

Slovenia

Facility Name

Site: 34001

City

Barcelona

ZIP/Postal Code

080200

Country

Spain

Facility Name

Site: 34002

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Site: 34009

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Site: 34004

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Site: 34005

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Site: 34003

City

Madrid

ZIP/Postal Code

28049

Country

Spain

Facility Name

Site: 34011

City

Mendaro

ZIP/Postal Code

20850

Country

Spain

Facility Name

Site: 34013

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Site: 34010

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Site: 34014

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Site: 34012

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Site: 46007

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Site: 46004

City

Halmstad

ZIP/Postal Code

302 46

Country

Sweden

Facility Name

Site: 46005

City

Karlshamn

ZIP/Postal Code

37435

Country

Sweden

Facility Name

Site: 46003

City

Norrtalje

ZIP/Postal Code

761 29

Country

Sweden

Facility Name

Site: 46002

City

Stockholm

ZIP/Postal Code

114 46

Country

Sweden

Facility Name

Site: 46001

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Site: 46006

City

Uppsala

ZIP/Postal Code

753 35

Country

Sweden

Facility Name

Site: 41001

City

Frauenfeld

ZIP/Postal Code

8501

Country

Switzerland

Facility Name

Site: 41003

City

Zurich

ZIP/Postal Code

8001

Country

Switzerland

Facility Name

Site: 90005

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Site: 90003

City

Ankara

ZIP/Postal Code

6100

Country

Turkey

Facility Name

Site: 90011

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Site: 90007

City

Diyarbakir

ZIP/Postal Code

21080

Country

Turkey

Facility Name

Site: 90004

City

Istanbul

Country

Turkey

Facility Name

Site: 90001

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Site: 90008

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Site: 90009

City

Manisa

ZIP/Postal Code

45010

Country

Turkey

Facility Name

Site: 90010

City

Sivas

ZIP/Postal Code

58140

Country

Turkey

Facility Name

Site: 38007

City

Chernivtsi

ZIP/Postal Code

58000

Country

Ukraine

Facility Name

Site: 38004

City

Dnepropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Site: 38001

City

Kharkov

ZIP/Postal Code

61057

Country

Ukraine

Facility Name

Site: 38002

City

Kiev

ZIP/Postal Code

2000

Country

Ukraine

Facility Name

Site: 38003

City

Lviv

ZIP/Postal Code

79044

Country

Ukraine

Facility Name

Site: 44027

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Site: 44029

City

Birmingham

ZIP/Postal Code

B15 2TG

Country

United Kingdom

Facility Name

Site: 44025

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Site: 44030

City

Chichester

ZIP/Postal Code

PO19 4SE

Country

United Kingdom

Facility Name

Site: 44028

City

Croydon

ZIP/Postal Code

CR7 7YE

Country

United Kingdom

Facility Name

Site: 44003

City

Devon

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

Site: 44001

City

Edgbaston

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Site: 44011

City

Glasgow

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

Site: 44023

City

Harrow

ZIP/Postal Code

HA 3UJ

Country

United Kingdom

Facility Name

Site: 44006

City

Kent

ZIP/Postal Code

ME7 5NY

Country

United Kingdom

Facility Name

Site: 44012

City

Leeds

ZIP/Postal Code

LS 9TF

Country

United Kingdom

Facility Name

Site: 44019

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Site: 44008

City

Liverpool

ZIP/Postal Code

L8 7SS

Country

United Kingdom

Facility Name

Site: 44010

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Site: 44017

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Site: 44013

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Site: 44022

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Site: 44021

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Site: 44009

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Site: 44007

City

Reading

ZIP/Postal Code

RG1 5AN

Country

United Kingdom

Facility Name

Site: 44005

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Site: 44020

City

Southampton

ZIP/Postal Code

SO16 5YA

Country

United Kingdom

Facility Name

Site: 44026

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

Facility Name

Site: 44024

City

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Site: 44002

City

West Yorkshire

ZIP/Postal Code

WF8 1PL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

Links:

URL

https://www.astellasclinicalstudyresults.com/study.aspx?ID=27

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

We'll reach out to this number within 24 hrs

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. (BEYOND)

Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases

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