Study to evaluate the efficacy, safety, and tolerability of Mirabegron in older adult subjects with overactive bladder (OAB), Trial ID 178-MA-1005

Study summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Additional Study Details

Phase

Product

N/A

Product

Mirabegron

Placebo

Type

Interventional

Masking

Double (Participant, Investigator)

Enrollment number

888

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Study documents

Scientific Results Summary

Available Language(s): English

Download Document(s)

Plain Language Summary

Available Language(s): English

Download Document(s)

Protocol

Available Language(s): English

Download Document(s)

Statistical Analysis Plan (SAP)

Available Language(s): English

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Would you like more information about clinical trial sites that are recruiting participants for Study to evaluate the efficacy, safety, and tolerability of Mirabegron in older adult subjects with overactive bladder (OAB)? Contact us by filling out your information to the right and we’ll respond to you.

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Locations

Completed

Site US00007

North Miami, FL, United States, 33161

Completed

Site US00029

Miami, FL, United States, 33144

Completed

Site US00098

Tacoma, WA, United States, 98405

Completed

Site US00014

Las Vegas, NV, United States, 89148

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Site US00082

Moncks Corner, SC, United States, 29461

Completed

Site US00148

Mobile, AL, United States, 36608

Withdrawn

Site US00115

Los Angeles, CA, United States, 90033

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Site CA00168

Toronto, Ontario, Canada, M4S 1Y2

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Site US00157

Wellington, FL, United States, 33449

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Site US00133

Cincinnati, Ohio, United States, 45212

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Site US00093

Saginaw, MI, United States, 48604

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Site US00064

Brooksville, FL, United States, 34601

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Site US00176

Anaheim, California, United States, 92801

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Site US00091

Brockton, MA, United States, 02301

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Site US00087

Nashville, TN, United States, 37209

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Site US00018

Edgewater, FL, United States, 32132

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Site US00144

Santa Maria, CA, United States, 93454

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Site US00146

Voorhees, NJ, United States, 08042

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Site US00101

Buffalo, NY, United States, 14203

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Site US00030

Gastonia, NC, United States, 28054

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Site US00081

Little Rock, AR, United States, 72205

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Site US00154

Chattanooga, Tennessee, United States, 37421

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Site US00039

Denver, CO, United States, 80220

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Site US00046

Jeffersonville, IN, United States, 47130

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Site US00132

Concord, NC, United States, 28025

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Site US00027

Fleming Island, FL, United States, 32003

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Site US00090

Washington, DC, United States, 20010

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Site US00135

San Diego, CA, United States, 92117

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Site US00045

Overland Park, KS, United States, 66202

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Site CA00164

Lévis, Quebec, Canada, G6W 0M6

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Site CA00126

Hamilton, ON, Canada, L8N 4A6

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Site US00021

Pompano Beach, FL, United States, 33060

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Site US00048

Beverly Hills, CA, United States, 90211

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Site US00134

West Des Moines, IA, United States, 50266

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Site US00103

Portland, OR, United States, 97239

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Site US00104

Augusta, KS, United States, 67010

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Site US00086

Norfolk, VA, United States, 23502

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Site US00043

Williamsville, NY, United States, 14221

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Site US00174

Hurst, Texas, United States, 76054

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Site US00137

Sartell, MN, United States, 56377

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Site US00015

Middleburg Heights, OH, United States, 44130

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Site US00006

New Bedford, MA, United States, 02740

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Site US00178

Alpharetta, Georgia, United States, 30005

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Site US00042

Miami, FL, United States, 33173

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Site US00016

Brooklyn, NY, United States, 11215

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Site US00153

Charlotte, NC, United States, 28209

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Site CA00074

Vancouver, British Columbia, Canada, V6J1S3

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Site CA00169

Sudbury, Ontario, Canada, P3E 3Z9

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Site US00067

Akron, OH, United States, 44313

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Site CA00106

Point Claire, Quebec, Canada, H9R4S3

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Site US00003

Kalamazoo, MI, United States, 49009

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Site US00019

Tucson, AZ, United States, 85745

Withdrawn

Site US00173

Mobile, Alabama, United States, 36608

Withdrawn

Site US00008

Tempe, AZ, United States, 85282

Completed

Site US00111

New Brunswick, NJ, United States, 08901

Completed

Site US00034

Los Angeles, CA, United States, 90027

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Site US00035

Port Orange, FL, United States, 32129

Withdrawn

Site US00069

Dallas, TX, United States, 75390

Completed

Site US00053

Franklin, TN, United States, 37064

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Site US00079

Oklahoma City, OK, United States, 73104

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Site US00084

Mentor, OH, United States, 44094

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Site US00044

Salt Lake City, UT, United States, 84107

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Site US00024

Edina, MN, United States, 55435

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Site US00131

Houston, Texas, United States, 77030

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Site US00036

Salt Lake City, UT, United States, 84124

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Site US00062

Madison, WI, United States, 53715

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Site US00108

Nashville, TN, United States, 37232

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Site US00083

Stanford, CA, United States, 94305

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Site US00076

Lakeland, FL, United States, 33805

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Site US00179

Jupiter, Florida, United States, 33458

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Site US00166

Winston-Salem, North Carolina, United States, 27103

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Site US00175

Austin, TX, United States, 78705

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Site US00004

Denver, CO, United States, 80239

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Site US00066

Huntsville, AL, United States, 35801

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Site US00040

New London, CT, United States, 06320

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Site CA00118

London, ON, Canada, N6A 4V2

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Site US00180

Pittsburgh, Pennsylvania, United States, 15236

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Site US00005

Savannah, GA, United States, 31406

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Site US00037

Miami, FL, United States, 33135

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Site US00010

Murrieta, CA, United States, 92562

Completed

Site CA00073

Point Claire, Quebec, Canada, H9R4S3

Completed

Site CA00130

Edmonton, Alberta, Canada, T5G 0B7

Withdrawn

Site US00088

Indianapolis, IN, United States, 46202

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Site US00177

Poughkeepsie, New York, United States, 12601

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Site CA00156

Sherbrooke, Quebec, Canada, J1H 1Z1

Completed

Site US00023

West Jordan, UT, United States, 84088

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Site US00011

Smyrna, TN, United States, 37167

Completed

Site CA00061

Sherbrooke, Quebec, Canada, J1H5N2

Completed

Site US00071

San Antonio, TX, United States, 78229

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Site US00050

Cincinnati, OH, United States, 45249

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Site US00017

Deland, FL, United States, 32720

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Site US00041

Boise, ID, United States, 83642

Completed

Site US00145

Watertown, MA, United States, 02472

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Site US00052

Nashville, TN, United States, 37211

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Site US00099

Tampa, FL, United States, 33606

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Site CA00155

Brampton, Ontario, Canada, L6T 4S5

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Site US00109

Orange, CA, United States, 92862

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Site US00026

Colorado Springs, CO, United States, 80907

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Site US00150

Hawaiian Gardens, CA, United States, 90716

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Site CA00116

Sarnia, ON, Canada, N7T4X3

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Site US00140

Albuquerque, NM, United States, 87102

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Site US00009

Anchorage, AK, United States, 99503

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Site US00165

Wilmington, North Carolina, United States, 28401

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Site CA00160

Quebec, Quebec, Canada, G1X 0B6

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Site US00122

Greensboro, NC, United States, 27403

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Site US00172

Lake Charles, Louisiana, United States, 70601

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Site US00142

Beverly Hills, CA, United States, 90212

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Site US00075

St. Petersburg, FL, United States, 33709

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Site US00002

Debary, FL, United States, 32713

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Site US00167

Seattle, WA, United States, 98150

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Site US00112

Los Angeles, CA, United States, 90017

Completed

Site US00095

Cleveland, OH, United States, 44109

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Site US00159

Billings, MT, United States, 59102

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Site US00161

Raleigh, North Carolina, United States, 27609

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Site US00125

LaCrosse, Wisconsin, United States, 54601

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Site US00170

Newport News, Virginia, United States, 23606

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Site US00085

Fargo, ND, United States, 58103

Completed

Site US00139

San Diego, CA, United States, 92120

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Site US00136

Northglenn, CO, United States, 80234

Completed

Site US00070

Norfolk, NE, United States, 68701

Completed

Site US00105

Newton, KS, United States, 67114

Completed

Site CA00129

Quebec, Quebec, Canada, G1S2L6

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Site CA00123

Corunna, ON, Canada, N0N1G0

Completed

Site US00001

Deland, FL, United States, 32720

Completed

Site US00063

Little Rock, AR, United States, 72120

Completed

Site US00068

San Antonio, TX, United States, 78209

Completed

Site US00057

Kissimmee, FL, United States, 34744

Completed

Site US00151

Hialeah, FL, United States, 33016

Withdrawn

Site US00117

Franklin, TN, United States, 37067

Completed

Site US00102

Norman, OK, United States, 73069

Completed

Site US00060

Greenwood, IN, United States, 46143

Completed

Site US00020

Tucson, AZ, United States, 85715

Completed

Site CA00158

Montreal, Quebec, Canada, H2Y 1S1

Withdrawn

Site US00013

Houston, TX, United States, 77055

Completed

Site US00162

Mount Pleasant, SC, United States, 29464

Completed

Site US00032

Bristol, Tennessee, United States, 37620

Completed

Site US00056

Grand Rapids, MI, United States, 49503

Completed

Site US00113

East Brunswick, NJ, United States, 08816

Completed

Site US00025

Annapolis, MD, United States, 21401

Completed

Site US00100

San Antonio, TX, United States, 78229

Completed

Site US00080

Coral Gables, FL, United States, 33134

Trial info

Follow Trial

Age

65+ years

Condition

Overactive Bladder Disease

Sex

Female & Male

Trial Dates

Oct 2014 - Nov 2017

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Additional Study Details

Inclusion Criteria

Inclusion Criteria assessed at Visit 1 (Screening):

Subject is willing and able to complete the micturition diary and questionnaires correctly.
Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.
Subject agrees not to participate in another interventional study from the time of screening until the final study visit.

Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

Subject continues to meet all inclusion criteria of Visit 1.
Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.
Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary.
Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary.

Exclusion Criteria assessed at Visit 1 (Screening):

Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.
Subject has Post-Void Residual Volume (PVR) greater than 150 mL.
Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.
Subject has an indwelling catheter or practices intermittent self-catheterization.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator’s discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
Subject has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
Subject resides in a nursing home.
Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator.
Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.
Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also not a candidate for the study.
Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.
Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc greater than 450 msec for males, QTc greater than 470 msec for females or a known history of QT prolongation.
Subject has a clinically significant ECG abnormality, as determined by the Investigator.
Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant by the Investigator.
Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists, or any of the inactive ingredients.
Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation.
Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
Subject with current history of alcohol and/or drug abuse.
Subject is using prohibited medications which cannot be stopped safely during the period.
Subject has stopped, started or changed the dose of a restricted medication within the last 30 days prior to Screening.
Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
Subject has previously received mirabegron.

Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]).
Subject was non-compliant during 2-week placebo run-in period, defined as taking less than 80% or greater than 120% of study medication.
Subject has any systolic blood pressure measurement > 180 mmHg or diastolic blood pressure measurement > 110 in the 3-day diary or during the baseline visit.

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Study to evaluate the efficacy, safety, and tolerability of Mirabegron in older adult subjects with overactive bladder (OAB)

Study summary

Additional Study Details

Study documents

Get more information

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