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



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:November 5, 2013
End Date:October 22, 2015

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

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.


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.
We found this trial at
119
sites
Albany, New York 12205
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Alpharetta, GA
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Bala-Cynwyd, PA
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boston, Massachusetts 02131
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida 34208
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brooklyn, New York 11220
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Burien, WA
Click here to add this to my saved trials
Carrollton, Texas 75010
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Corpus Christi, Texas 78414
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Garden City, New York 11530
?
mi
from
Garden City, NY
Click here to add this to my saved trials
?
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
Glendora, California 91741
?
mi
from
Glendora, CA
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greer, South Carolina 29650
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hawaiian Gardens, California 90716
?
mi
from
Hawaiian Gardens, CA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Homestead, FL
Click here to add this to my saved trials
Houston, Texas 77062
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hurst, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
?
mi
from
Kingston, NY
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89106
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Lawrenceville, New Jersey 86480
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lyndhurst, Ohio 44124
?
mi
from
Lyndhurst, OH
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Missoula, MT
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Moorestown, New Jersey 08057
?
mi
from
Moorestown, NJ
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
1156 Bowman Road
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Mountlake Terrace, Washington 98043
?
mi
from
Mountlake Terrace, WA
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
1 Lake Street
New Britain, Connecticut 06052
?
mi
from
New Britain, CT
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10018
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newburgh, New York 12550
?
mi
from
Newburgh, NY
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
21 Crossroads Drive
Owings Mills, Maryland 21117
?
mi
from
Owings Mills, MD
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Paramount, California 90723
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Pembroke Pines, Florida 33027
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85051
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida 33317
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Roswell, GA
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Sandy, UT
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Sartell, MN
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66218
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
Shreveport, Louisiana 71106
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
?
mi
from
Simpsonville, SC
Click here to add this to my saved trials