A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Summary

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Conditions

• Urinary Bladder Diseases
• Urinary Bladder Overactive
• Urologic Diseases

Interventions

DRUG

mirabegron 25 mg

Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 50 mg

Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 5 mg

Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 10 mg

Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 25 mg matching placebo

Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 50 mg matching placebo

Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 5 mg matching placebo

Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 10 mg matching placebo

Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.

  lead INDUSTRY

Principal Investigators

• Clinical Study Manager · Astellas Pharma Europe Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-10

Primary Completion

2014-11-24

Completion

2014-11-25

FDA Drug

Yes

Countries

• United States
• Armenia
• Australia
• Austria
• Belgium
• Canada
• Czechia
• Denmark
• Finland
• France
• Georgia
• Germany
• Greece
• Hungary
• Ireland
• Israel
• Italy
• Lebanon
• Netherlands
• Norway
• Poland
• Portugal
• Romania
• Russia
• Slovakia
• Slovenia
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations