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A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) (BESIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01908829
First Posted: July 26, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
  Purpose
The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Condition Intervention Phase
Urinary Bladder Diseases Urinary Bladder Overactive Urologic Diseases Drug: mirabegron 25 mg Drug: mirabegron 50 mg Drug: solifenacin 5 mg Drug: solifenacin 10 mg Drug: mirabegron 25 mg matching placebo Drug: mirabegron 50 mg matching placebo Drug: solifenacin 5 mg matching placebo Drug: solifenacin 10 mg matching placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):

Primary Outcome Measures:
  • Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and end of treatment (up to 12 weeks) ]
    The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.


Secondary Outcome Measures:
  • Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

  • Change From Baseline in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).

  • Number of Incontinence Episodes Reported During the 3-Day Diary [ Time Frame: Weeks 4, 8 and 12 ]
    The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.

  • Change From Baseline in Mean Volume Voided (MVV) Per Micturition [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period.

  • Change From Baseline to EoT in Corrected Micturition Frequency (CMF) [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.

  • Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4.

  • Number of UI Episodes Reported During the 3-Day Diary [ Time Frame: Weeks 4, 8 and 12 ]
    Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.

  • Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.

  • Change From Baseline in Mean Number of Pads Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

  • Number of Pads Used During the 3-Day Diary [ Time Frame: Weeks 4, 8 and 12 ]
    The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.

  • Change From Baseline in Mean Number of Nocturia Episodes [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.

  • Number of Nocturia Episodes Reported Over 3-Day Diary [ Time Frame: Weeks 4, 8 and 12 ]
    The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.

  • Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

  • Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

  • Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

  • Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

  • Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

  • Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

  • Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Change From Baseline in OAB-q HRQL Subscale Score: Coping [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Change From Baseline in OAB-q HRQL Subscale Score: Concern [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Change From Baseline in OAB-q HRQL Subscale Score: Sleep [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).

  • Change From Baseline in Patient Perception Bladder Control (PPBC) Score [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.

  • Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) [ Time Frame: End of treatment (up to 12 weeks) ]
    The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).

  • Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Weeks 4, 8 and 12 ]
    Incontinence was defined as any involuntary leakage of urine.

  • Percentage of Participants With Zero Incontinence Episodes Postbaseline [ Time Frame: Weeks 4, 8 and 12 ]
    Incontinence was defined as any involuntary leakage of urine.

  • Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline [ Time Frame: Weeks 4, 8 and 12 ]
    Micturitions were defined as voluntary urinations (excluding incontinence only episodes).

  • Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score [ Time Frame: Weeks 4, 8 and 12 ]
    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

  • Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score [ Time Frame: Weeks 4, 8 and 12 ]
    HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

  • Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC [ Time Frame: Weeks 4, 8 and 12 ]
    The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.

  • Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC [ Time Frame: Weeks 4, 8 and 12 ]
    The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.

  • Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) ]
    AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.

  • Change From Baseline in Post Void Residual (PVR) Volume [ Time Frame: Baseline and weeks 4, 8 & 12 ]
    PVR Volume was assessed by bladder scan.


Enrollment: 2174
Actual Study Start Date: July 10, 2013
Study Completion Date: November 25, 2014
Primary Completion Date: November 24, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination (solifenacin + mirabegron)
Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.
Drug: mirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
Other Names:
  • Betmiga
  • Myrbetriq
  • YM178
  • Betanis
Drug: mirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
Other Names:
  • YM905
  • Vesitrim
  • Vesikur
  • Vesicare
Drug: solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
Other Names:
  • Vesicare
  • Vesitrim
  • YM905
  • Vesikur
Drug: solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Active Comparator: Solifenacin 5 mg
Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period
Drug: solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
Other Names:
  • Vesicare
  • Vesitrim
  • YM905
  • Vesikur
Drug: mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Drug: mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Drug: solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Active Comparator: Solifenacin 10 mg
Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Drug: solifenacin 10 mg
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
Other Names:
  • Vesicare
  • Vesitrim
  • YM905
  • Vesikur
Drug: mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Drug: mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Drug: solifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main Inclusion at Screening:

    1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit
    2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
    3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
  • Main Inclusion at Run-in (Visit 2):

    1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
    2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
    3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
  • Main Inclusion at Randomization (Visit 3):

    1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.

Exclusion Criteria:

  • Main Exclusion at Screening:

    1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
    2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).
    3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
    4. Subject has an indwelling catheter or practices intermittent self catheterization.
    5. Subject has evidence of a UTI.
    6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
    7. Subject has moderate to severe hepatic impairment
    8. Subject has severe renal impairment or End Stage Renal disease
    9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
    10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
    11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
    12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
    13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
  • Main Exclusion at Randomization (visit 3):

    1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
    2. Subject does not desire an increase in study medication.
    3. Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary.
    4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
    5. Subject has a clinically significant abnormal ECG
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908829


  Show 219 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT01908829     History of Changes
Other Study ID Numbers: 905-EC-012
2012-005401-41 ( EudraCT Number )
First Submitted: July 24, 2013
First Posted: July 26, 2013
Results First Submitted: August 2, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Vesitrim
Betanis
Urgency
Frequency
Mirabegron
YM178
Betmiga
Vesicare
Micturition
YM905
Solifenacin
Urinary incontinence
Overactive Bladder (OAB)
Myrbetriq
Vesikur
Urgency incontinence

Additional relevant MeSH terms:
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents