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: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Drug: Mirabegron
Drug: Solifenacin succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1887
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirabegron Drug: Mirabegron
oral tablet
Other Names:
  • YM178
  • Betanis
  • Myrbetriq
Active Comparator: Solifenacin Drug: Solifenacin succinate
oral tablet
Other Names:
  • Vesicare
  • Vesitrim
  • Vesikur
  • YM905

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  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: NCT01638000

  Show 217 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

Additional Information:
No publications provided

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
Study First Received: July 9, 2012
Last Updated: May 19, 2014
Health Authority: Armenia: Ministry of Health
Austria: Agency for Health and Food Safety
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Jordan: Ethical Committee
Kazakhstan: Ministry of Public Health
Latvia: State Agency of Medicines
Lebanon: Ministry of Public Health
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: The Central Register of Clinical Trials
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Overactive Bladder (OAB)
Urinary incontinence
Urgency incontinence
Frequency
Urgency
Micturition
YM178
Mirabegron
Solifenacin
Vesicare
Vesitrim

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

ClinicalTrials.gov processed this record on September 18, 2014