Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Last updated: July 15, 2024
Sponsor: Urovant Sciences GmbH
Overall Status: Completed

Phase

3

Condition

Enuresis

Overactive Bladder

Prostate Disorders

Treatment

Vibegron

Placebo

Clinical Study ID

NCT03902080
URO-901-3005
2018-003135-30
  • Ages > 45
  • Male

Study Summary

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

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

Total Participants: 1105
Treatment Group(s): 2
Primary Treatment: Vibegron
Phase: 3
Study Start date:
March 26, 2019
Estimated Completion Date:
June 15, 2023

Connect with a study center

  • Uz Antwerpen

    Edegem, Antwerpen 02650
    Belgium

    Site Not Available

  • Algemeen Stedelijk Ziekenhuis

    Aalst, Oost-Vlaanderen 09300
    Belgium

    Site Not Available

  • Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst

    Aalst, Oost-Vlaanderen 09300
    Belgium

    Site Not Available

  • AZ Maria Middelares - Campus Maria Middelares

    Gent, Oost-Vlaanderen 09000
    Belgium

    Site Not Available

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant 03000
    Belgium

    Site Not Available

  • AZ Delta - Campus Wilgenstraat

    Roeselare, West-Vlaanderen 08800
    Belgium

    Site Not Available

  • CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

    Liège, 04000
    Belgium

    Site Not Available

  • Private Practice

    Brampton, Ontario L6T 4S5
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Center

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Private Practice

    Pointe-claire, Quebec H9R 4S3
    Canada

    Site Not Available

  • Diex Research Quebec Inc.

    Quebec City, Quebec G1N 4V3
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire De Sherbrooke (CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Diex Research Victoriaville Inc.

    Victoriaville, Quebec G6P 6P6
    Canada

    Site Not Available

  • University of Szeged

    Szeged, Csongrád 06725
    Hungary

    Site Not Available

  • DRC Kft.

    Sopron, Gyor-Moson-Sopron H-9400
    Hungary

    Site Not Available

  • Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

    Budapest, 01204
    Hungary

    Site Not Available

  • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

    Budapest, 1204
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 01082
    Hungary

    Site Not Available

  • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny

    Csongrad, 06640
    Hungary

    Site Not Available

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

    Nyiregyhaza, 04400
    Hungary

    Site Not Available

  • Uro-Clin Kft.

    Pècs, 07621
    Hungary

    Site Not Available

  • Szent Borbala Korhaz

    Tatabanya, 02800
    Hungary

    Site Not Available

  • Hospital of University of Health Sciences Kauno Klinikos

    Kaunas, Kauno Apskritis LT-50161
    Lithuania

    Site Not Available

  • JSC Saules seimos medicinos centras

    Kaunas, Kauno Apskritis LT-49449
    Lithuania

    Site Not Available

  • Kaunas Hospital of Lithuanian Universoity of Health Sciences

    Kaunas, Kauno Apskritis LT-47144
    Lithuania

    Site Not Available

  • Uab "Vakk"

    Kaunas, Kauno Apskritis LT-50128
    Lithuania

    Site Not Available

  • Klaipedos Universitetine Ligonine (Klaipeda Hospital)

    Klaipeda, Klaipedos Apskritis LT-92288
    Lithuania

    Site Not Available

  • Respublikine Klaipedos ligonine - Urology

    Klaipeda, Klaipedos Apskritis LT-92231
    Lithuania

    Site Not Available

  • National Cancer Institute

    Vilnius, Vilniaus Apskritis LT-08660
    Lithuania

    Site Not Available

  • Republican Vilnius University Hospital

    Vilnius, Vilniaus Apskritis LT-08660
    Lithuania

    Site Not Available

  • Vilnius City Clinical Hospital

    Vilnius, Vilniaus Apskritis LT-10207
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Vilniaus Apskritis LT-08661
    Lithuania

    Site Not Available

  • Wojewodzki Szpital Specjalist

    Wroclaw, Dolnoslaskie 51-124
    Poland

    Site Not Available

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, Dolnoslaskie Województwo 54-144
    Poland

    Site Not Available

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, Kujawsko-pomorskie 85-650
    Poland

    Site Not Available

  • NZOZ Specjalista

    Kutno, Lódzkie 99-300
    Poland

    Site Not Available

  • ETG Lodz

    Lodz, Lódzkie 90-302
    Poland

    Site Not Available

  • Centrum Medyczne PROMED

    Krakow, Malopolskie Województwo 31-513
    Poland

    Site Not Available

  • Prywatny Gabinet Urologiczny dr n. med. Maciej Szwedowski

    Opole, Opolskie 45-086
    Poland

    Site Not Available

  • Szpital Specjalistyczny Slupsk

    Slupsk, Pomorskie 76-200
    Poland

    Site Not Available

  • Centrum Urologiczne sp. z o.o.

    Myslowice, Silesia 41-400
    Poland

    Site Not Available

  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.

    Poznan, Wielkopolskie 60-856
    Poland

    Site Not Available

  • Centrum Medyczne Linden

    Krakow, 37-721
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Nzoz Heureka

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Lexmedica Hanna Durbajlo-Gradziel

    Wroclaw, 53-114
    Poland

    Site Not Available

  • Hospital Garcia de Orta

    Almada, 2805-267
    Portugal

    Site Not Available

  • Centro Clínico Académico Braga, Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Hospital Senhora de Oliveiro Guimaraes EPE

    Guimaraes, 4835-044
    Portugal

    Site Not Available

  • H. Egas Moniz. Centro Hospitalar Lisboa Ocidental

    Lisboa, 1349-019
    Portugal

    Site Not Available

  • Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • H. Santo António. Centro Hospitalar do Porto

    Porto, 4099-001
    Portugal

    Site Not Available

  • Hospital Santiago Apostol

    Miranda de Ebro, Burgos 09200
    Spain

    Site Not Available

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Site Not Available

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid 28660
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Majadahonda, Madrid 28007
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid 28702
    Spain

    Site Not Available

  • Hospital de Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Clínica Universitaria de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • H.U. Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Urology Centers of Alabama

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Private Practice

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Coastal Clinical Research, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Alaska Urological Institute/AK Clinical Research Center

    Anchorage, Alaska 99503
    United States

    Site Not Available

  • Gen1 Research- Arizona Urology Specialists

    Glendale, Arizona 85308
    United States

    Site Not Available

  • Urological Associates Of Southern Arizona

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Incontinence Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • California Research Medical Group, Inc.

    Fullerton, California 92835
    United States

    Site Not Available

  • San Diego Clinical Trials

    La Mesa, California 91942
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • West Coast Urology

    Los Alamitos, California 90720
    United States

    Site Not Available

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Site Not Available

  • Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Tri Valley Urology Medical Group

    Murrieta, California 92562
    United States

    Site Not Available

  • Northern California Research Corp

    Sacramento, California 95821
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • Urology Specialists of Southern California (USSC)

    Sherman Oaks, California 91411
    United States

    Site Not Available

  • Skyline Urology

    Torrance, California 90505
    United States

    Site Not Available

  • Urology Associates - Urology

    Denver, Colorado 80220
    United States

    Site Not Available

  • Advanced Research for Health Improvement

    Bonita Springs, Florida 34134
    United States

    Site Not Available

  • Imagine Research of Palm Beach County - Urology

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Urological Research Network Corp

    Hialeah, Florida 33016
    United States

    Site Not Available

  • LCC Medical Research Institute

    Miami, Florida 33126
    United States

    Site Not Available

  • Quantum Clinical Trials

    Miami, Florida 33140
    United States

    Site Not Available

  • Private Practice

    Orlando, Florida 32808
    United States

    Site Not Available

  • Urology Center Of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • Pinellas Urology, Inc.

    Saint Petersburg, Florida 33710
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Florida Urology Partners, LLP

    Tampa, Florida 33615
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Meridian Clinical Research - Urology

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Idaho Urologic Institute

    Meridian, Idaho 83642
    United States

    Site Not Available

  • NorthShore University Health System

    Glenview, Illinois 60153
    United States

    Site Not Available

  • First Urology

    Jefferson, Indiana 47130
    United States

    Site Not Available

  • First Urology

    Jeffersonville, Indiana 47130
    United States

    Site Not Available

  • The Iowa Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • GU Research Network/Wichita Urology Group

    Wichita, Kansas 67226
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Regional Urology, LLC

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Towson, Maryland 21204
    United States

    Site Not Available

  • Boston Clinical Trials Inc - Urology

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Mens Health Boston - Urology

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Beaumont Hospital Royal Oak - Urology Research

    Royal Oak, Michigan 48703
    United States

    Site Not Available

  • Michigan Intitute of Urology - Urology

    Troy, Michigan 48084
    United States

    Site Not Available

  • CentraCare Clinic - Adult & Pediatric Urology

    Sartell, Minnesota 56377
    United States

    Site Not Available

  • Poplar Bluff Urology

    Poplar Bluff, Missouri 63901
    United States

    Site Not Available

  • Adult & Pediatric Urology P.C. - Urology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Excel Clinical Research - Internal Medicine

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Private Practice

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Premier Urology Group, LLC

    Edison, New Jersey 08837
    United States

    Site Not Available

  • New Jersey Urology NJU

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • New Jersey Urology, LLC

    Mount Laurel, New Jersey 08054
    United States

    Site Not Available

  • New Jersey Urology, LLC

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Urology Group Of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • Brooklyn Urology Research Group

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Western New York Urology Associates

    Buffalo, New York 14203
    United States

    Site Not Available

  • AccuMed research Asociates

    Garden City, New York 11530
    United States

    Site Not Available

  • Urological Surgeons of Long Island

    Garden City, New York 11530
    United States

    Site Not Available

  • Columbia University Medical Center - Clinical Research

    New York, New York 10032
    United States

    Site Not Available

  • Manhattan Research Associates

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)

    Plainview, New York 11803
    United States

    Site Not Available

  • Private Practice

    Poughkeepsie, New York 12603
    United States

    Site Not Available

  • Duke Medical Center - Urology

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina 27612
    United States

    Site Not Available

  • Alliance Urology Specialists - Greensboro

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Triad Clinical Trials

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Peters Medical Research

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Associated Urologists of North Carolina - Urology

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Southwest Urology Inc

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Clinical Research Solutions

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Lowcountry Urology

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Vanderbilt University Medical

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Advances In Health, Inc.

    Houston, Texas 77030
    United States

    Site Not Available

  • North Texas Family Medicine

    Plano, Texas 75093
    United States

    Site Not Available

  • Discovery Clinical Trials

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Baylor Scott & White Medical Center

    Temple, Texas 76508
    United States

    Site Not Available

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Urology of Virginia (UVA)

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

  • Seattle Urology Research Center

    Burien, Washington 98166
    United States

    Site Not Available

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