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

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Placebo; Drug: Mirabegron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00912964

2008-007087-42 (EudraCT Number)

178-CL-074

Details and patient eligibility

About

The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.

Enrollment: 2,030 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 (OAB) 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 is using medications intended to treat OAB
• Patient has an indwelling catheter or practices intermittent self-catheterization
• Patient has diabetic neuropathy
• Patient has evidence of 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 participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
• 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 transpeptidase (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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2,030 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Mirabegron 25 mg

Experimental group

Description:

Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.

Treatment:

Drug: Mirabegron

Mirabegron 50 mg

Experimental group

Description:

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

Treatment:

Drug: Mirabegron