A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder (ARIES)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Placebo; Drug: Mirabegron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662909

178-CL-047

Details and patient eligibility

About

The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder

Enrollment: 2,149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is willing and able to complete the micturition diary and questionnaires correctly
• Patient has symptoms of overactive bladder for ≥ 3 months
• Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
• Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

Exclusion criteria

• Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
• Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Patient has an indwelling catheter or practices intermittent self-catheterization
• Patient has diabetic neuropathy
• Patient 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
• Patient receives non-drug treatment including electro-stimulation therapy
• Patient has severe hypertension
• Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor (ß-AR) agonists, or any of the other inactive ingredients
• Patient has been treated with any investigational drug or device within 30 days
• Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
• Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or Gamma glutamyl transferase (γ-GT) > 3x ULN
• Patient has a clinically significant abnormal electrocardiogram (ECG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,149 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching placebo tablets orally once a day for 12 weeks

Treatment:

Drug: Placebo

Mirabegron 50 mg

Experimental group

Description:

Participants received mirabegron 50 mg tablets orally once a day for 12 weeks

Treatment:

Drug: Mirabegron

Mirabegron 100 mg

Experimental group

Description:

Participants received mirabegron 100 m tablets, orally once a day for 12 weeks

Treatment:

Drug: Mirabegron