A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder (Symphony)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01340027
First received: April 20, 2011
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.


Condition Intervention Phase
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Drug: Mirabegron
Drug: Solifenacin succinate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.


Secondary Outcome Measures:
  • Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.

  • Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.

  • Change From Baseline to Each Visit in Mean Volume Voided Per Micturition [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.

  • Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.

  • Percentage of Participants With a Micturition Response [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.

  • Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.

  • Percentage of Participants With Zero Incontinence Episodes Post-baseline [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.

  • Percentage of Participants With 50% Reduction in Incontinence Episodes [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.

  • Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.

  • Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.

  • Change From Baseline to Each Visit in Mean Level of Urgency [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.

  • Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.

  • Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.

  • Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.

  • Percentage of Participants With Improvement in PPBC [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.

  • Percentage of Participants With Major Improvement in PPBC [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.

  • Percentage of Participants With Deterioration in PPBC [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.

  • Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.

  • Percentage of Participants With a Symptom Bother Response [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.

  • Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.

  • Percentage of Participants With a Health-related Quality of Life Total Score Response [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.

  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:

    I have no problems in walking about; I have some problems in walking about; I am confined to bed.

    In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.


  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:

    I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.

    In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.


  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.

    In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.


  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:

    I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.


  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:

    I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.


  • Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.

  • Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.

  • Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.


Enrollment: 1307
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received matching placebo tablets orally once a day for 12 weeks
Drug: Placebo
oral
Active Comparator: Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Active Comparator: Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Active Comparator: Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Active Comparator: Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Active Comparator: Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 2.5 mg and Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 2.5 mg and Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 5 mg and Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 5 mg and Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 10 mg and Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur
Experimental: Solifenacin 10 mg and Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Myrbetric
  • Myrbetriq
  • Betanis
  • Betmiga
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • Vesikur

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria at Visit 1/Screening:

    • Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m^2 and a total body weight between 50 and 95 kg;
    • Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
    • Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
  • Inclusion Criteria at Visit 3/Baseline:

    • Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
    • Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.

Exclusion Criteria:

  • Exclusion Criteria at Visit 1/Screening:

    • Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;
    • Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.
    • Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
    • Subject has significant post-void residual (PVR) volume (> 150 mL);
    • 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 the cough provocation test);
    • Subject has a neurological cause for detrusor overactivity;
    • Subject has an indwelling catheter or practices intermittent self-catheterization;
    • Subject has diabetic neuropathy;
    • Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
    • Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
    • Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
    • Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;
    • Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
    • Subject is receiving current 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 is using medications intended to treat OAB or prohibited medications.
    • Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
    • Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease);
    • Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
  • Exclusion Criteria at Visit 2/Placebo Run-In:

    • Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days;
    • Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
    • Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);
    • Subject has serum creatinine > 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) > 3x ULN, or total bilirubin > 2x ULN, as assessed in Screening samples;
  • Exclusion Criteria at Visit 3/Baseline:

    • Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period;
    • Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340027

  Show 133 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Director: Study Physician Astellas Pharma Europe B.V.
Principal Investigator: Principal Investigator Bristol Urological Institute
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01340027     History of Changes
Other Study ID Numbers: 178-CL-100, 2010-020601-32
Study First Received: April 20, 2011
Results First Received: June 23, 2015
Last Updated: July 27, 2015
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Ministry of Health
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Hungary: Research Ethics Medical Committee
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Norway: Ministry of Health and Care Services
Poland: Ministry of Health
Portugal: Ethics Committee for Clinical Research
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: Ministry of Health

Keywords provided by Astellas Pharma Inc:
Overactive bladder (OAB)
Frequency
Micturition
Urgency
Urinary incontinence
Urgency incontinence
YM178

Additional relevant MeSH terms:
Signs and Symptoms
Urinary Bladder Diseases
Urinary Bladder, Overactive
Urologic Diseases
Urological Manifestations
Lower Urinary Tract Symptoms
Mirabegron
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on August 27, 2015