Clinical trial NCT03902080: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Benign Prostatic Hyperplasia
Vibegron
Beta-3 adrenergic receptor (ß3-AR)
ß3-AR agonist
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 1105
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day
timeFrame: Baseline; Week 12
measure: Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night
timeFrame: Baseline; Week 12
measure: Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline
timeFrame: Baseline; Week 12
measure: Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
timeFrame: Baseline; Week 12
measure: Change From Baseline at Week 12 in the Average Volume Voided Per Micturition
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Huntsville
country: United States
facility: Private Practice
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Glendale
country: United States
facility: Gen1 Research- Arizona Urology Specialists
state: Arizona
city: Tucson
country: United States
facility: Urological Associates Of Southern Arizona
state: Arizona
city: Fullerton
country: United States
facility: California Research Medical Group, Inc.
state: California
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Alamitos
country: United States
facility: West Coast Urology
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Urology Specialists of Southern California (USSC)
state: California
city: Torrance
country: United States
facility: Skyline Urology
state: California
city: Denver
country: United States
facility: Urology Associates - Urology
state: Colorado
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County - Urology
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Hialeah
country: United States
facility: Urological Research Network Corp
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Private Practice
state: Florida
city: Pompano Beach
country: United States
facility: Urology Center Of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLP
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research - Urology
state: Georgia
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Glenview
country: United States
facility: NorthShore University Health System
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Wichita
country: United States
facility: GU Research Network/Wichita Urology Group
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials Inc - Urology
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Mens Health Boston - Urology
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital Royal Oak - Urology Research
state: Michigan
city: Sartell
country: United States
facility: CentraCare Clinic - Adult & Pediatric Urology
state: Minnesota
city: Poplar Bluff
country: United States
facility: Poplar Bluff Urology
state: Missouri
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C. - Urology
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research - Internal Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Private Practice
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group, LLC
state: New Jersey
city: Englewood
country: United States
facility: New Jersey Urology NJU
state: New Jersey
city: Mount Laurel
country: United States
facility: New Jersey Urology, LLC
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology, LLC
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: Western New York Urology Associates
state: New York
city: Garden City
country: United States
facility: AccuMed research Asociates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island
state: New York
city: New York
country: United States
facility: Manhattan Research Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Clinical Research
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Plainview
country: United States
facility: Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
state: New York
city: Poughkeepsie
country: United States
facility: Private Practice
state: New York
city: Durham
country: United States
facility: Duke Medical Center - Urology
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists - Greensboro
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina - Urology
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: North Charleston
country: United States
facility: Lowcountry Urology
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research LLC
state: Utah
city: Virginia Beach
country: United States
facility: Urology of Virginia (UVA)
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Edegem
country: Belgium
facility: Uz Antwerpen
state: Antwerpen
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
state: Oost-Vlaanderen
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares - Campus Maria Middelares
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
state: Vlaams Brabant
city: Roeselare
country: Belgium
facility: AZ Delta - Campus Wilgenstraat
state: West-Vlaanderen
city: Liège
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
city: Brampton
country: Canada
facility: Private Practice
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Quebec City
country: Canada
facility: Diex Research Quebec Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire De Sherbrooke (CHUS)
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Research Victoriaville Inc.
state: Quebec
city: Szeged
country: Hungary
facility: University of Szeged
state: Csongrád
city: Sopron
country: Hungary
facility: DRC Kft.
state: Gyor-Moson-Sopron
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
city: Csongrad
country: Hungary
facility: Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
city: Pècs
country: Hungary
facility: Uro-Clin Kft.
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
city: Kaunas
country: Lithuania
facility: Kaunas Hospital of Lithuanian Universoity of Health Sciences
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: JSC Saules seimos medicinos centras
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: Uab "Vakk"
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: Hospital of University of Health Sciences Kauno Klinikos
state: Kauno Apskritis
city: Klaipeda
country: Lithuania
facility: Respublikine Klaipedos ligonine - Urology
state: Klaipedos Apskritis
city: Klaipeda
country: Lithuania
facility: Klaipedos Universitetine Ligonine (Klaipeda Hospital)
state: Klaipedos Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Republican Vilnius University Hospital
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Vilnius City Clinical Hospital
state: Vilniaus Apskritis
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnia
state: Dolnoslaskie Województwo
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalist
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
state: Kujawsko-pomorskie
city: Kutno
country: Poland
facility: NZOZ Specjalista
state: Lódzkie
city: Lodz
country: Poland
facility: ETG Lodz
state: Lódzkie
city: Krakow
country: Poland
facility: Centrum Medyczne PROMED
state: Malopolskie Województwo
city: Slupsk
country: Poland
facility: Szpital Specjalistyczny Slupsk
state: Pomorskie
city: Myslowice
country: Poland
facility: Centrum Urologiczne sp. z o.o.
state: Silesia
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.
state: Wielkopolskie
city: Krakow
country: Poland
facility: Centrum Medyczne Linden
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
city: Piaseczno
country: Poland
facility: Nzoz Heureka
city: Wroclaw
country: Poland
facility: Lexmedica Hanna Durbajlo-Gradziel
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Braga
country: Portugal
facility: Centro Clínico Académico Braga, Hospital de Braga
city: Guimaraes
country: Portugal
facility: Hospital Senhora de Oliveiro Guimaraes EPE
city: Lisboa
country: Portugal
facility: H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: H. Santo António. Centro Hospitalar do Porto
city: Miranda de Ebro
country: Spain
facility: Hospital Santiago Apostol
state: Burgos
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital General Universitario Gregorio Marañón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Clínica Universitaria de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: H.U. Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
Study officials:
affiliation: Urovant Sciences
name: Study Director
role: STUDY_DIRECTOR
References: