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)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases

Treatments: Drug: Solifenacin succinate; Drug: Mirabegron

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638000

178-EC-001

2011-005713-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Enrollment: 1,887 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 electrocardiogram (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,887 participants in 2 patient groups

Mirabegron 50 mg

Experimental group

Description:

Participants who received mirabegron 50 mg once daily for 12 weeks.

Treatment:

Drug: Mirabegron

Solifenacin 5 mg

Active Comparator group

Description:

Participants who received solifenacin 5 mg once daily for 12 weeks.

Treatment:

Drug: Solifenacin succinate