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)

September 21, 2023 updated by: Urovant Sciences GmbH

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 04000
        • CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 02650
        • UZ Antwerpen
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 09300
        • Algemeen Stedelijk Ziekenhuis
      • Aalst, Oost-Vlaanderen, Belgium, 09300
        • Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
      • Gent, Oost-Vlaanderen, Belgium, 09000
        • Az Maria Middelares - Campus Maria Middelares
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 03000
        • UZ Leuven - Campus Gasthuisberg
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 08800
        • AZ Delta - Campus Wilgenstraat
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 4S5
        • Private Practice
      • Sarnia, Ontario, Canada, N7t 4X3
        • Bluewater Clinical Research Group Inc
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Center
    • Quebec
      • Quebec City, Quebec, Canada, G1N 4V3
        • DIEX Research Quebec Inc.
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Diex Research Sherbrooke Inc.
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Diex Research Victoriaville Inc.
  • Hungary
      • Budapest, Hungary, 01082
        • Semmelweis Egyetem
      • Budapest, Hungary, 01204
        • Jahn Ferenc Dél-pesti Kórház és Rendelőintézet
      • Csongrad, Hungary, 06640
        • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
      • Nyiregyhaza, Hungary, 04400
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
      • Pècs, Hungary, 07621
        • Uro-Clin Kft.
      • Tatabanya, Hungary, 02800
        • Szent Borbala Korhaz
    • Csongrád
      • Szeged, Csongrád, Hungary, 06725
        • University of Szeged
    • Gyor-Moson-Sopron
      • Sopron, Gyor-Moson-Sopron, Hungary, H-9400
        • DRC Kft.
  • Lithuania
    • Kauno Apskritis
      • Kaunas, Kauno Apskritis, Lithuania, LT-47144
        • Kaunas Hospital of Lithuanian Universoity of Health Sciences
      • Kaunas, Kauno Apskritis, Lithuania, LT-49449
        • JSC Saules seimos medicinos centras
      • Kaunas, Kauno Apskritis, Lithuania, LT-50128
        • Uab "Vakk"
      • Kaunas, Kauno Apskritis, Lithuania, LT-50161
        • Hospital of University of Health Sciences Kauno Klinikos
    • Klaipedos Apskritis
      • Klaipeda, Klaipedos Apskritis, Lithuania, LT-92231
        • Respublikine Klaipedos ligonine - Urology
      • Klaipeda, Klaipedos Apskritis, Lithuania, LT-92288
        • Klaipedos Universitetine Ligonine (Klaipeda Hospital)
    • Vilniaus Apskritis
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08660
        • National Cancer Institute
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08660
        • Republican Vilnius University Hospital
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Klinikos
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-10207
        • Vilnius City Clinical Hospital
  • Poland
      • Krakow, Poland, 37-721
        • Centrum Medyczne Linden
      • Oswiecim, Poland, 32-600
        • Medicome Sp. z o.o.
      • Piaseczno, Poland, 05-500
        • NZOZ Heureka
      • Wroclaw, Poland, 53-114
        • Lexmedica Hanna Durbajlo-Gradziel
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 51-124
        • Wojewodzki Szpital Specjalist
    • Dolnoslaskie Województwo
      • Wroclaw, Dolnoslaskie Województwo, Poland, 54-144
        • EuroMediCare Szpital Specjalistyczny z Przychodnia
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-650
        • Nasz Lekarz Osrodek Badan Klinicznych
    • Lódzkie
      • Kutno, Lódzkie, Poland, 99-300
        • NZOZ Specjalista
      • Lodz, Lódzkie, Poland, 90-302
        • ETG Lodz
    • Malopolskie Województwo
      • Krakow, Malopolskie Województwo, Poland, 31-513
        • Centrum Medyczne Promed
    • Pomorskie
      • Slupsk, Pomorskie, Poland, 76-200
        • Szpital Specjalistyczny Slupsk
    • Silesia
      • Myslowice, Silesia, Poland, 41-400
        • Centrum Urologiczne sp. z o.o.
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-856
        • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico Braga, Hospital de Braga
      • Guimaraes, Portugal, 4835-044
        • Hospital Senhora de Oliveiro Guimaraes EPE
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisboa, Portugal, 1349-019
        • H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
      • Porto, Portugal, 4099-001
        • H. Santo Antonio. Centro Hospitalar do Porto
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28027
        • Clinica Universitaria de Navarra
      • Málaga, Spain, 29010
        • H.U. Virgen de la Victoria
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spain, 46026
        • Hospital Universitari I Politecnic La Fe
    • Burgos
      • Miranda de Ebro, Burgos, Spain, 09200
        • Hospital Santiago Apostol
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion ALcorcon
      • Boadilla del Monte, Madrid, Spain, 28660
        • Hospital Universitario HM Monteprincipe
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Majadahonda, Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • San Sebastián de los Reyes, Madrid, Spain, 28702
        • Hospital Universitario Infanta Sofía
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Huntsville, Alabama, United States, 35801
        • Private Practice
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Gen1 Research- Arizona Urology Specialists
      • Tucson, Arizona, United States, 85741
        • Urological Associates of Southern Arizona
    • California
      • Fullerton, California, United States, 92835
        • California Research Medical Group, Inc.
      • La Mesa, California, United States, 91942
        • San Diego Clinical Trials
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Los Alamitos, California, United States, 90720
        • West Coast Urology
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Los Angeles, California, United States, 90033
        • Norris Comprehensive Cancer Center
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Medical Group
      • Sacramento, California, United States, 95821
        • Northern California Research Corp
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • Sherman Oaks, California, United States, 91411
        • Urology Specialists of Southern California (USSC)
      • Torrance, California, United States, 90505
        • Skyline Urology
    • Colorado
      • Denver, Colorado, United States, 80220
        • Urology Associates - Urology
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Imagine Research of Palm Beach County - Urology
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Hialeah, Florida, United States, 33016
        • Urological Research Network Corp
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute
      • Miami, Florida, United States, 33140
        • Quantum Clinical Trials
      • Orlando, Florida, United States, 32808
        • Private Practice
      • Pompano Beach, Florida, United States, 33060
        • Urology Center Of Florida
      • Saint Petersburg, Florida, United States, 33710
        • Pinellas Urology, Inc.
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners, LLP
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Meridian Clinical Research - Urology
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • Illinois
      • Glenview, Illinois, United States, 60153
        • Northshore University Health System
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • First Urology
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • Kansas
      • Wichita, Kansas, United States, 67226
        • GU Research Network/Wichita Urology Group
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Delricht Research
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials Inc - Urology
      • Chestnut Hill, Massachusetts, United States, 02467
        • Mens Health Boston - Urology
      • Watertown, Massachusetts, United States, 02472
        • Bay State Clinical Trials, Inc.
    • Michigan
      • Royal Oak, Michigan, United States, 48703
        • Beaumont Hospital Royal Oak - Urology Research
    • Minnesota
      • Sartell, Minnesota, United States, 56377
        • CentraCare Clinic - Adult & Pediatric Urology
    • Missouri
      • Poplar Bluff, Missouri, United States, 63901
        • Poplar Bluff Urology
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult & Pediatric Urology P.C. - Urology
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Private Practice
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research - Internal Medicine
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Premier Urology Group, LLC
      • Englewood, New Jersey, United States, 07631
        • New Jersey Urology NJU
      • Mount Laurel, New Jersey, United States, 08054
        • New Jersey Urology, LLC
      • Voorhees, New Jersey, United States, 08043
        • New Jersey Urology, LLC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Buffalo, New York, United States, 14203
        • Western New York Urology Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island
      • Garden City, New York, United States, 11530
        • AccuMed research Asociates
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10016
        • Manhattan Research Associates
      • New York, New York, United States, 10032
        • Columbia University Medical Center - Clinical Research
      • Plainview, New York, United States, 11803
        • Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
      • Poughkeepsie, New York, United States, 12603
        • Private Practice
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center - Urology
      • Fayetteville, North Carolina, United States, 27612
        • Carolina Institute for Clinical Research
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialists - Greensboro
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina - Urology
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Solutions
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Urology
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio
      • San Antonio, Texas, United States, 78258
        • Discovery Clinical Trials
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research LLC
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia (UVA)
    • Washington
      • Burien, Washington, United States, 98166
        • Seattle Urology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy 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 the satisfaction of the investigator
  • Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over 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 Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.

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, be responsible for urgency, frequency, or incontinence
  • Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or 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 125 mL
  • Has a history of or current nocturnal polyuria
  • Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical 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, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
  • Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
  • Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
  • Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
  • Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary 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 the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibegron 75 mg
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Drug: Vibegron
oral administration
Other Names:
  • RVT-901
  • MK-4618
  • KRP-114V
  • URO-901
Placebo Comparator: Placebo
Participants will receive matching placebo orally once daily for 24 weeks.
Drug: Placebo
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline at Week 12 in the average number of micturition episodes per day
Time Frame: Baseline; Week 12
Baseline; Week 12
Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day
Time Frame: Baseline; Week 12
Baseline; Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline at Week 12 in the average number of nocturia episodes per night
Time Frame: Baseline; Week 12
Baseline; Week 12
Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline
Time Frame: Baseline; Week 12
Baseline; Week 12
Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall)
Time Frame: Baseline; Week 12
Baseline; Week 12
Change from Baseline at Week 12 in the average volume voided per micturition
Time Frame: Baseline; Week 12
Baseline; Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urovant Sciences GmbH

Investigators

  • Study Director: Study Director, Urovant Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2019

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-901-3005
  • 2018-003135-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.

IPD Sharing Time Frame

The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.

IPD Sharing Access Criteria

Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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