A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Are 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: June 6, 2013
Last verified: June 2013

July 9, 2012
June 6, 2013
June 2012
April 2013   (final data collection date for primary outcome measure)
Change from baseline in the mean number of micturitions per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01638000 on ClinicalTrials.gov Archive Site
  • Proportion of subjects reporting at least one treatment-emergent adverse event of dry mouth, constipation or blurred vision during double-blind treatment period [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes (grade 3 or 4) per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean level of urgency [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of pads used per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturia episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with 50% decrease in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with zero incontinence episodes per 24 hours who were incontinent at baseline [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total Euroqol EQ-5D score (and subscales scores) [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total OABq score (and subscale score) [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in TS-VAS score and Treatment Satisfaction Likert scale [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 1 to 6 items improvement from baseline in Treatment Satisfaction Likert scale [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with micturition normalization to < 8 micturitions per 24 hours [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PPBC scores [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 1 point improvement from baseline in PPBC [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with major (≥ 2 points) improvement from baseline in PPBC [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Are Previously Treated With Another Medicine But Were Not Satisfied With That Treatment
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

The purpose of this study is to determine whether an experimental medicine (mirabegron) is as good as a currently approved medicine (solifenacin) in the treatment of patients with overactive bladder who have had previous treatment with antimuscarinics (the main group of medicines for treatment of overactive bladder) but were not satisfied with the symptom relief of their last treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Urinary Bladder, Overactive
  • Urinary Bladder Diseases
  • Urologic Diseases
  • Drug: Mirabegron
    oral tablet
    Other Names:
    • YM178
    • Betanis
    • Myrebtriq
  • Drug: Solifenacin succinate
    oral tablet
    Other Names:
    • Vesicare
    • Vesitrim
    • Vesikur
    • YM905
  • Experimental: Mirabegron
    Intervention: Drug: Mirabegron
  • Active Comparator: Solifenacin
    Intervention: Drug: Solifenacin succinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1887
April 2013
April 2013   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Armenia,   Austria,   Belarus,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Georgia,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Kazakhstan,   Latvia,   Lebanon,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT01638000
178-EC-001, 2011-005713-37
No
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
Astellas Pharma Europe Ltd.
Not Provided
Study Director: Clinical Study Manager Astellas Pharma Europe Ltd.
Astellas Pharma Inc
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP