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)

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902080
• Other study ID #: URO-901-3005
• Secondary ID: 2018-003135-30
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2019
• Est. completion date: June 15, 2023

Study information

• Verified date: September 2023
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1105
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Vibegron
oral administration
• Placebo
oral administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Hungary,  Lithuania,  Poland,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline at Week 12 in the average number of micturition episodes per day		Baseline; Week 12
Primary	Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day		Baseline; Week 12
Secondary	Change from Baseline at Week 12 in the average number of nocturia episodes per night		Baseline; Week 12
Secondary	Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline		Baseline; Week 12
Secondary	Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall)		Baseline; Week 12
Secondary	Change from Baseline at Week 12 in the average volume voided per micturition		Baseline; Week 12