Phase
Condition
Enuresis
Overactive Bladder
Prostate Disorders
Treatment
Vibegron
Placebo
Clinical Study ID
Ages > 45 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant should have been on and agree to continue to stay on a stable dose ofbenign prostatic hyperplasia (BPH) treatment with either a) alpha blockermonotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
Participant has an International Prostate Symptom Score total score of ≥ 8
Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to thesatisfaction of the investigator
Participant must have both additional qualifications based on the 3-day BladderDiary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day overthe 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per dayover the 3-day diary period
Participant must have a post void residual volume value of < 100 mL
Having at least 2 average nocturia episodes per night based on 3-day Bladder Diaryat baseline. Nocturia is defined as waking to pass urine during the main sleepperiod.
Exclusion
Exclusion Criteria:
Participant has a history of 24-hour urine volume greater than 3,000 mL
Has lower urinary tract pathology that could, in the opinion of the investigator, beresponsible for urgency, frequency, or incontinence
Has a history of prostate surgery, including minimally invasive transurethral ortransrectal procedures, procedural treatments for BPH within 6 months of Screeningor has a planned prostate surgery
Has a history of urinary retention requiring an intervention (e.g., catheterization)for any reason
Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125mL
Has a history of or current nocturnal polyuria
Has an active or recurrent (> 3 episodes per year) urinary tract infection byclinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, definedas ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a singlespecimen)
Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligramsper deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting bloodglucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, isuncontrolled
Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters ofmercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heartrate (by pulse) > 100 beats per minute (min)
Has a history of cerebral vascular accident, transient ischemic attack, unstableangina, myocardial infarction, coronary artery interventions (e.g., coronary arterybypass grafting or percutaneous coronary interventions [e.g., angioplasty, stentinsertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6months prior to the Screening Visit
Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upperlimit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN ifsecondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
Has a history or current evidence of any condition, therapy, laboratory abnormality,or other circumstances that might, in the opinion of the investigator, confound theresults of the study, interfere with the participant's ability to comply with thestudy procedure, or make participation in the study not in the participant's bestinterest
Study Design
Connect with a study center
Uz Antwerpen
Edegem, Antwerpen 02650
BelgiumSite Not Available
Algemeen Stedelijk Ziekenhuis
Aalst, Oost-Vlaanderen 09300
BelgiumSite Not Available
Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
Aalst, Oost-Vlaanderen 09300
BelgiumSite Not Available
AZ Maria Middelares - Campus Maria Middelares
Gent, Oost-Vlaanderen 09000
BelgiumSite Not Available
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant 03000
BelgiumSite Not Available
AZ Delta - Campus Wilgenstraat
Roeselare, West-Vlaanderen 08800
BelgiumSite Not Available
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
Liège, 04000
BelgiumSite Not Available
Private Practice
Brampton, Ontario L6T 4S5
CanadaSite Not Available
Bluewater Clinical Research Group Inc
Sarnia, Ontario N7T 4X3
CanadaSite Not Available
Sunnybrook Health Sciences Center
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Toronto Western Hospital
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Private Practice
Pointe-claire, Quebec H9R 4S3
CanadaSite Not Available
Diex Research Quebec Inc.
Quebec City, Quebec G1N 4V3
CanadaSite Not Available
Centre Hospitalier Universitaire De Sherbrooke (CHUS)
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec J1L 0H8
CanadaSite Not Available
Diex Research Victoriaville Inc.
Victoriaville, Quebec G6P 6P6
CanadaSite Not Available
University of Szeged
Szeged, Csongrád 06725
HungarySite Not Available
DRC Kft.
Sopron, Gyor-Moson-Sopron H-9400
HungarySite Not Available
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
Budapest, 01204
HungarySite Not Available
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, 1204
HungaryActive - Recruiting
Semmelweis Egyetem
Budapest, 01082
HungarySite Not Available
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
Csongrad, 06640
HungarySite Not Available
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyiregyhaza, 04400
HungarySite Not Available
Uro-Clin Kft.
Pècs, 07621
HungarySite Not Available
Szent Borbala Korhaz
Tatabanya, 02800
HungarySite Not Available
Hospital of University of Health Sciences Kauno Klinikos
Kaunas, Kauno Apskritis LT-50161
LithuaniaSite Not Available
JSC Saules seimos medicinos centras
Kaunas, Kauno Apskritis LT-49449
LithuaniaSite Not Available
Kaunas Hospital of Lithuanian Universoity of Health Sciences
Kaunas, Kauno Apskritis LT-47144
LithuaniaSite Not Available
Uab "Vakk"
Kaunas, Kauno Apskritis LT-50128
LithuaniaSite Not Available
Klaipedos Universitetine Ligonine (Klaipeda Hospital)
Klaipeda, Klaipedos Apskritis LT-92288
LithuaniaSite Not Available
Respublikine Klaipedos ligonine - Urology
Klaipeda, Klaipedos Apskritis LT-92231
LithuaniaSite Not Available
National Cancer Institute
Vilnius, Vilniaus Apskritis LT-08660
LithuaniaSite Not Available
Republican Vilnius University Hospital
Vilnius, Vilniaus Apskritis LT-08660
LithuaniaSite Not Available
Vilnius City Clinical Hospital
Vilnius, Vilniaus Apskritis LT-10207
LithuaniaSite Not Available
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Vilniaus Apskritis LT-08661
LithuaniaSite Not Available
Wojewodzki Szpital Specjalist
Wroclaw, Dolnoslaskie 51-124
PolandSite Not Available
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, Dolnoslaskie Województwo 54-144
PolandSite Not Available
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Kujawsko-pomorskie 85-650
PolandSite Not Available
NZOZ Specjalista
Kutno, Lódzkie 99-300
PolandSite Not Available
ETG Lodz
Lodz, Lódzkie 90-302
PolandSite Not Available
Centrum Medyczne PROMED
Krakow, Malopolskie Województwo 31-513
PolandSite Not Available
Prywatny Gabinet Urologiczny dr n. med. Maciej Szwedowski
Opole, Opolskie 45-086
PolandSite Not Available
Szpital Specjalistyczny Slupsk
Slupsk, Pomorskie 76-200
PolandSite Not Available
Centrum Urologiczne sp. z o.o.
Myslowice, Silesia 41-400
PolandSite Not Available
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, Wielkopolskie 60-856
PolandSite Not Available
Centrum Medyczne Linden
Krakow, 37-721
PolandSite Not Available
Medicome Sp. z o.o.
Oswiecim, 32-600
PolandSite Not Available
Nzoz Heureka
Piaseczno, 05-500
PolandSite Not Available
Lexmedica Hanna Durbajlo-Gradziel
Wroclaw, 53-114
PolandSite Not Available
Hospital Garcia de Orta
Almada, 2805-267
PortugalSite Not Available
Centro Clínico Académico Braga, Hospital de Braga
Braga, 4710-243
PortugalSite Not Available
Hospital Senhora de Oliveiro Guimaraes EPE
Guimaraes, 4835-044
PortugalSite Not Available
H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
Lisboa, 1349-019
PortugalSite Not Available
Hospital de Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
H. Santo António. Centro Hospitalar do Porto
Porto, 4099-001
PortugalSite Not Available
Hospital Santiago Apostol
Miranda de Ebro, Burgos 09200
SpainSite Not Available
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid 28922
SpainSite Not Available
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid 28660
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Majadahonda, Madrid 28007
SpainSite Not Available
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid 28702
SpainSite Not Available
Hospital de Basurto
Bilbao, Vizcaya 48013
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainSite Not Available
Clínica Universitaria de Navarra
Madrid, 28027
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
H.U. Virgen de la Victoria
Málaga, 29010
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainSite Not Available
Urology Centers of Alabama
Homewood, Alabama 35209
United StatesSite Not Available
Private Practice
Huntsville, Alabama 35801
United StatesSite Not Available
Coastal Clinical Research, Inc.
Mobile, Alabama 36608
United StatesSite Not Available
Alaska Urological Institute/AK Clinical Research Center
Anchorage, Alaska 99503
United StatesSite Not Available
Gen1 Research- Arizona Urology Specialists
Glendale, Arizona 85308
United StatesSite Not Available
Urological Associates Of Southern Arizona
Tucson, Arizona 85741
United StatesSite Not Available
Incontinence Research Institute
Encinitas, California 92024
United StatesSite Not Available
California Research Medical Group, Inc.
Fullerton, California 92835
United StatesSite Not Available
San Diego Clinical Trials
La Mesa, California 91942
United StatesSite Not Available
Clinical Trials Research
Lincoln, California 95648
United StatesSite Not Available
West Coast Urology
Los Alamitos, California 90720
United StatesSite Not Available
American Institute of Research
Los Angeles, California 90017
United StatesSite Not Available
Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Tri Valley Urology Medical Group
Murrieta, California 92562
United StatesSite Not Available
Northern California Research Corp
Sacramento, California 95821
United StatesSite Not Available
Medical Center for Clinical Research
San Diego, California 92108
United StatesSite Not Available
Urology Specialists of Southern California (USSC)
Sherman Oaks, California 91411
United StatesSite Not Available
Skyline Urology
Torrance, California 90505
United StatesSite Not Available
Urology Associates - Urology
Denver, Colorado 80220
United StatesSite Not Available
Advanced Research for Health Improvement
Bonita Springs, Florida 34134
United StatesSite Not Available
Imagine Research of Palm Beach County - Urology
Boynton Beach, Florida 33435
United StatesSite Not Available
Tampa Bay Medical Research
Clearwater, Florida 33761
United StatesSite Not Available
Urological Research Network Corp
Hialeah, Florida 33016
United StatesSite Not Available
LCC Medical Research Institute
Miami, Florida 33126
United StatesSite Not Available
Quantum Clinical Trials
Miami, Florida 33140
United StatesSite Not Available
Private Practice
Orlando, Florida 32808
United StatesSite Not Available
Urology Center Of Florida
Pompano Beach, Florida 33060
United StatesSite Not Available
Pinellas Urology, Inc.
Saint Petersburg, Florida 33710
United StatesSite Not Available
Precision Clinical Research
Sunrise, Florida 33351
United StatesSite Not Available
Florida Urology Partners, LLP
Tampa, Florida 33615
United StatesSite Not Available
Clinical Research of Central Florida
Winter Haven, Florida 33880
United StatesSite Not Available
Meridian Clinical Research - Urology
Savannah, Georgia 31405
United StatesSite Not Available
Idaho Urologic Institute
Meridian, Idaho 83642
United StatesSite Not Available
NorthShore University Health System
Glenview, Illinois 60153
United StatesSite Not Available
First Urology
Jefferson, Indiana 47130
United StatesSite Not Available
First Urology
Jeffersonville, Indiana 47130
United StatesSite Not Available
The Iowa Clinic
West Des Moines, Iowa 50266
United StatesSite Not Available
GU Research Network/Wichita Urology Group
Wichita, Kansas 67226
United StatesSite Not Available
DelRicht Research
New Orleans, Louisiana 70115
United StatesSite Not Available
Regional Urology, LLC
Shreveport, Louisiana 71106
United StatesSite Not Available
Chesapeake Urology Research Associates
Baltimore, Maryland 21204
United StatesSite Not Available
Chesapeake Urology Research Associates
Towson, Maryland 21204
United StatesSite Not Available
Boston Clinical Trials Inc - Urology
Boston, Massachusetts 02131
United StatesSite Not Available
Mens Health Boston - Urology
Chestnut Hill, Massachusetts 02467
United StatesSite Not Available
Bay State Clinical Trials, Inc.
Watertown, Massachusetts 02472
United StatesSite Not Available
Beaumont Hospital Royal Oak - Urology Research
Royal Oak, Michigan 48703
United StatesSite Not Available
Michigan Intitute of Urology - Urology
Troy, Michigan 48084
United StatesSite Not Available
CentraCare Clinic - Adult & Pediatric Urology
Sartell, Minnesota 56377
United StatesSite Not Available
Poplar Bluff Urology
Poplar Bluff, Missouri 63901
United StatesSite Not Available
Adult & Pediatric Urology P.C. - Urology
Omaha, Nebraska 68114
United StatesSite Not Available
Excel Clinical Research - Internal Medicine
Las Vegas, Nevada 89109
United StatesSite Not Available
Private Practice
Las Vegas, Nevada 89148
United StatesSite Not Available
Premier Urology Group, LLC
Edison, New Jersey 08837
United StatesSite Not Available
New Jersey Urology NJU
Englewood, New Jersey 07631
United StatesSite Not Available
New Jersey Urology, LLC
Mount Laurel, New Jersey 08054
United StatesSite Not Available
New Jersey Urology, LLC
Voorhees, New Jersey 08043
United StatesSite Not Available
Urology Group Of New Mexico
Albuquerque, New Mexico 87109
United StatesSite Not Available
Albany Medical College
Albany, New York 12208
United StatesSite Not Available
Brooklyn Urology Research Group
Brooklyn, New York 11201
United StatesSite Not Available
Western New York Urology Associates
Buffalo, New York 14203
United StatesSite Not Available
AccuMed research Asociates
Garden City, New York 11530
United StatesSite Not Available
Urological Surgeons of Long Island
Garden City, New York 11530
United StatesSite Not Available
Columbia University Medical Center - Clinical Research
New York, New York 10032
United StatesSite Not Available
Manhattan Research Associates
New York, New York 10016
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10065
United StatesSite Not Available
Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
Plainview, New York 11803
United StatesSite Not Available
Private Practice
Poughkeepsie, New York 12603
United StatesSite Not Available
Duke Medical Center - Urology
Durham, North Carolina 27710
United StatesSite Not Available
Carolina Institute for Clinical Research
Fayetteville, North Carolina 27612
United StatesSite Not Available
Alliance Urology Specialists - Greensboro
Greensboro, North Carolina 27403
United StatesSite Not Available
Triad Clinical Trials
Greensboro, North Carolina 27410
United StatesSite Not Available
Peters Medical Research
High Point, North Carolina 27262
United StatesSite Not Available
Associated Urologists of North Carolina - Urology
Raleigh, North Carolina 27612
United StatesSite Not Available
Southwest Urology Inc
Cleveland, Ohio 44130
United StatesSite Not Available
Clinical Research Solutions
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Lowcountry Urology
North Charleston, South Carolina 29406
United StatesSite Not Available
Vanderbilt University Medical
Nashville, Tennessee 37212
United StatesSite Not Available
Urology Clinics of North Texas
Dallas, Texas 75231
United StatesSite Not Available
Advances In Health, Inc.
Houston, Texas 77030
United StatesSite Not Available
North Texas Family Medicine
Plano, Texas 75093
United StatesSite Not Available
Discovery Clinical Trials
San Antonio, Texas 78258
United StatesSite Not Available
Urology San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Baylor Scott & White Medical Center
Temple, Texas 76508
United StatesSite Not Available
Wasatch Clinical Research LLC
Salt Lake City, Utah 84107
United StatesSite Not Available
Urology of Virginia (UVA)
Virginia Beach, Virginia 23462
United StatesSite Not Available
Seattle Urology Research Center
Burien, Washington 98166
United StatesSite Not Available


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