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This Was a Multinational Stud...

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

NCT ID: NCT01972841

Last Updated: 2024-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-05

Study Completion Date

2015-10-22

Brief Summary

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The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

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Detailed Description

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Conditions

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Urinary Bladder Overactive Urinary Bladder Diseases\Urologic Diseases Overactive Bladder Urgency Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1: Solifenacin 5 mg + Mirabegron 25 mg

Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

Group Type EXPERIMENTAL

Solifenacin succinate

Intervention Type DRUG

Oral tablet

Mirabegron

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

2: Solifenacin 5 mg + Mirabegron 50 mg

Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

Group Type EXPERIMENTAL

Solifenacin succinate

Intervention Type DRUG

Oral tablet

Mirabegron

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

3: Placebo

Participants who received matching placebo once a day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo to match solifenacin succinate

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

4: Solifenacin 5 mg

Participants who received solifenacin 5 mg once a day for 12 weeks.

Group Type ACTIVE_COMPARATOR

Solifenacin succinate

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

5:Mirabegron 25 mg

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

Group Type ACTIVE_COMPARATOR

Mirabegron

Intervention Type DRUG

Oral tablet

Placebo to match solifenacin succinate

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

6: Mirabegron 50 mg

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

Group Type ACTIVE_COMPARATOR

Mirabegron

Intervention Type DRUG

Oral tablet

Placebo to match solifenacin succinate

Intervention Type DRUG

Oral tablet

Placebo to match mirabegron

Intervention Type DRUG

Oral tablet

Interventions

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Solifenacin succinate

Oral tablet

Intervention Type DRUG

Mirabegron

Oral tablet

Intervention Type DRUG

Placebo to match solifenacin succinate

Oral tablet

Intervention Type DRUG

Placebo to match mirabegron

Oral tablet

Intervention Type DRUG

Other Intervention Names

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Vesikur Vesitrim YM905 Vesicare YM178 Betmiga Betanis Myrbetriq

Eligibility Criteria

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Inclusion Criteria

* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
* Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria

* Subject had significant PVR volume (\> 150 mL);
* Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
* Subject had an indwelling catheter or practices intermittent self catheterization.
* Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
* Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
* Subject had moderate to severe hepatic impairment
* Subject had severe renal impairment
* Subject had a clinically significant abnormal ECG
* Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
* Subject had an average QTcF interval \> 450 ms for males or \> 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
* Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Site US10049 Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Site Status

Site US10112 TFI, LLC

Mobile, Alabama, United States

Site Status

Site US10104 Clinical Research Advantage, Inc.

Chandler, Arizona, United States

Site Status

Site US10021 Beach Clinical Studies

Phoenix, Arizona, United States

Site Status

Site US10122 Orange County Research Institute

Anaheim, California, United States

Site Status

Site US10098 Skyline Research

Cerritos, California, United States

Site Status

Site US10539 Citrus Valley Medical Research

Glendora, California, United States

Site Status

Site US10082 American Clinical Trials

Hawaiian Gardens, California, United States

Site Status

Site US10132 Axis Clinical Trials

Los Angeles, California, United States

Site Status

Site US10133 Axis Clinical Trials

Los Angeles, California, United States

Site Status

Site US10536 Stanford School of Medicine

Palo Alto, California, United States

Site Status

Site US10149 Bayview Research Group

Paramount, California, United States

Site Status

Site US10559 UC Davis Medical Center

Sacramento, California, United States

Site Status

Site US10003 San Diego Clinical Trials

San Diego, California, United States

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Site US10545 San Diego Institute for Sexual Medicine

San Diego, California, United States

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Site US10106 West Coast Clinical Research

Tarzana, California, United States

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Site US10595 Bayview Research Group

Valley Village, California, United States

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Site US10034 Urology Center of Colorado

Denver, Colorado, United States

Site Status

Site US10070 Physicians' Research Options/Red Rocks OB/GYN

Lakewood, Colorado, United States

Site Status

Site US10053 Western Clinical Research, Inc.

Wheat Ridge, Colorado, United States

Site Status

Site US10128 Clinical Research Center of CT

Danbury, Connecticut, United States

Site Status

Site US10018 Grove Hill Clinical Research

New Britain, Connecticut, United States

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Site US10170 Yale - New Haven Hospital West Haven VAMC

New Haven, Connecticut, United States

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Site US10123 Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status