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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01638000
First received: July 9, 2012
Last updated: September 7, 2016
Last verified: September 2016
Results First Received: July 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Urologic Diseases
Urinary Bladder, Overactive
Urinary Bladder Diseases
Interventions: Drug: Mirabegron
Drug: Solifenacin succinate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited for this study were men and women with overactive bladder (OAB) who had received 1 or more antimuscarinics in the past and who were dissatisfied with their last antimuscarinic treatment due to lack of efficacy (provided that their previous antimuscarinic was not solifenacin).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entered a 2-week, single-blind, placebo run-in period and completed a daily diary (including 3 consecutive days prior to the randomization visit for micturition and incontinence). After this, participants' eligibility criteria were re-confirmed and they were then randomized into the double-blind treatment period of the study.

Reporting Groups
  Description
Mirabegron 50 mg Participants who received mirabegron 50 mg once daily for 12 weeks.
Solifenacin 5 mg Participants who received solifenacin 5 mg once daily for 12 weeks.

Participant Flow:   Overall Study
    Mirabegron 50 mg     Solifenacin 5 mg  
STARTED     943     944  
Received at Least 1 Double-Blind Dose     936     934  
COMPLETED     883     873  
NOT COMPLETED     60     71  
Randomized but Never Received Drug                 7                 10  
Adverse Event                 14                 16  
Lack of Efficacy                 5                 6  
Protocol Violation                 11                 13  
Withdrawal by Subject                 21                 24  
Miscellaneous                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set (SAF) - consisted of all randomized patients who received ≥ 1 dose of double-blind study drug.

Reporting Groups
  Description
Mirabegron 50 mg Participants who received mirabegron 50 mg once daily for 12 weeks.
Solifenacin 5 mg Participants who received solifenacin 5 mg once daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Mirabegron 50 mg     Solifenacin 5 mg     Total  
Number of Participants  
[units: participants]
  936     934     1870  
Age  
[units: years]
Mean (Standard Deviation)
  56.7  (14.25)     57.4  (13.60)     57.0  (13.93)  
Gender  
[units: participants]
     
Female     712     709     1421  
Male     224     225     449  
Mean Micturitions / 24 hours [1]
[units: micturitions]
Mean (Standard Deviation)
  11.6  (3.25)     11.4  (2.89)     11.5  (3.08)  
Mean Incontinence Episodes / 24 hours [2]
[units: incontinence episodes]
Mean (Standard Deviation)
  2.1  (2.30)     2.1  (2.05)     2.1  (2.17)  
Mean Urgency Incontinence Episodes / 24 hours [3]
[units: urgency incontinence episodes]
Mean (Standard Deviation)
  1.9  (1.99)     2.0  (1.94)     2.0  (1.96)  
Mean Urgency Episodes (grade 3 or 4) / 24 hours [4]
[units: urgency episodes]
Mean (Standard Deviation)
  7.7  (4.75)     7.8  (4.46)     7.8  (4.61)  
Mean Level of Urgency [5]
[units: units on a scale]
Mean (Standard Deviation)
  2.6  (0.49)     2.6  (0.49)     2.6  (0.49)  
Mean Nocturia Episodes / 24 hours [6]
[units: nocturia episodes]
Mean (Standard Deviation)
  2.3  (1.41)     2.3  (1.42)     2.3  (1.41)  
Mean Number of Pads Used / 24 hours [7]
[units: pads]
Mean (Standard Deviation)
  3.1  (3.43)     3.3  (3.70)     3.2  (3.57)  
[1] SAF population. The number of participants are 933 and 932. 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.
[2] SAF population with baseline value > 0. The number of participants are 410 and 424. 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.
[3] SAF population with baseline value > 0. The number of participants are 401 and 413. 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.
[4] SAF population with baseline value > 0. The number of participants are 931 and 931. 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.
[5] SAF population. The number of participants are 933 and 932. 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.
[6] SAF population with baseline value > 0. The number of participants are 890 and 895. 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.
[7] SAF population with baseline value > 0. The number of participants are 585 and 580. The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.



  Outcome Measures
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1.  Primary:   Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours   [ Time Frame: Baseline and final visit (up to Week 12) ]

2.  Secondary:   Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period   [ Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) ]

3.  Secondary:   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 ]

4.  Secondary:   Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

5.  Secondary:   Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

6.  Secondary:   Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

7.  Secondary:   Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

8.  Secondary:   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   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

9.  Secondary:   Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

10.  Secondary:   Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

11.  Secondary:   Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment   [ Time Frame: Baseline and Week 4, Week 8 , Week 12 ]

12.  Secondary:   Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

13.  Secondary:   Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

14.  Secondary:   Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

15.  Secondary:   Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

16.  Secondary:   Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit   [ Time Frame: Week 4, Week 8, Week 12 ]

17.  Secondary:   Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire   [ Time Frame: Baseline and Week 4 ]

18.  Secondary:   Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 4 ]

19.  Secondary:   Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 4 ]

20.  Secondary:   Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 4 ]

21.  Secondary:   Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 4 ]

22.  Secondary:   Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 8 ]

23.  Secondary:   Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 8 ]

24.  Secondary:   Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 8 ]

25.  Secondary:   Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 8 ]

26.  Secondary:   Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 8 ]

27.  Secondary:   Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 12 ]

28.  Secondary:   Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 12 ]

29.  Secondary:   Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 12 ]

30.  Secondary:   Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 12 ]

31.  Secondary:   Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and Week 12 ]

32.  Secondary:   Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and final visit (up to Week 12) ]

33.  Secondary:   Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and final visit (up to Week 12) ]

34.  Secondary:   Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and final visit (up to Week 12) ]

35.  Secondary:   Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and final visit (up to Week 12) ]

36.  Secondary:   Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire   [ Time Frame: Baseline and final visit (up to Week 12) ]

37.  Secondary:   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)   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

38.  Secondary:   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   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

39.  Secondary:   Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)   [ Time Frame: Baseline and Week 4, Week 8, Week 12 ]

40.  Secondary:   Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)   [ Time Frame: Baseline and Week 12 ]

41.  Secondary:   Change From Baseline to Week 12 and the Final Visit in the Patient’s Assessment of Treatment Satisfaction Questionnaire-Likert Scale   [ Time Frame: Baseline and Week 12 ]

42.  Secondary:   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   [ Time Frame: Baseline to Week 12 ]

43.  Secondary:   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   [ Time Frame: Baseline to Week 12 ]

44.  Secondary:   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   [ Time Frame: Baseline to Week 12 ]

45.  Secondary:   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   [ Time Frame: Baseline to final visit (up to Week 12) ]

46.  Secondary:   Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit   [ Time Frame: Baseline to Week 12 ]

47.  Secondary:   Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit   [ Time Frame: Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Astellas Pharma Europe Ltd
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01638000     History of Changes
Other Study ID Numbers: 178-EC-001
2011-005713-37 ( EudraCT Number )
Study First Received: July 9, 2012
Results First Received: July 19, 2016
Last Updated: September 7, 2016
Health Authority: Norway: Norwegian Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Belarus: Ministry of Health
Canada: Health Canada
Austria: Agency for Health and Food Safety
Lebanon: Ministry of Public Health
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Slovenia: Agency for Medicinal Products - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ukraine: Ministry of Health
Denmark: Danish Medicines Agency
Turkey: Ministry of Health
Finland: Finnish Medicines Agency
Switzerland: Swissmedic
Armenia: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Lithuania: State Medicine Control Agency - Ministry of Health
Italy: Ministry of Health
Latvia: State Agency of Medicines
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Kazakhstan: Ministry of Public Health
Czech Republic: State Institute for Drug Control
Portugal: National Pharmacy and Medicines Institute
Jordan: Ethical Committee
Sweden: Medical Products Agency
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Egypt: Ministry of Health, Drug Policy and Planning Center