Clinical trial NCT03583372: An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
Official title: An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Beta-3 adrenergic receptor (β3-AR) agonists
incontinence
OAB
vibegron
urge urinary incontinence
Urinary bladder, overactive
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Agents
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2018-07-11
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.


Eligibility criteria: Inclusion Criteria:

1. Has completed participation in study RVT-901-3003.
2. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.

Exclusion Criteria:

1. Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
2. Has coronary or neurovascular interventions planned during the duration of the study.
3. Has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose \>200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
4. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) \> 100 beats per minute.
5. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
6. Has alanine aminotransferase or aspartate aminotransferase \> 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) \> 1.5 x ULN (or \> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003.
7. Has an estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
8. Use of any prohibited medications as detailed in Section 7.7.3.
9. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
10. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
11. Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-3003.
12. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
13. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.

Primary outcomes:
measure: Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
timeFrame: up to 56 weeks
Secondary outcomes:
measure: Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
timeFrame: Baseline; Week 52
measure: CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
timeFrame: Baseline; Week 52
measure: CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
timeFrame: Baseline; Week 52
measure: CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
timeFrame: Baseline; Week 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research Inc.
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Hawaiian Gardens
country: United States
facility: American Clinical Trials
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Prime-Care Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials LLC
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center Inc.
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: WR MCCCR
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Valley Village
country: United States
facility: Bayview Research Group LLC
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting LLC
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research LLC
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research Inc.
state: Florida
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research Health Center
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic Inc.
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute Inc.
state: Florida
city: Miami
country: United States
facility: Nuren Medical Research Center
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Inc.
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research LLC
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Peachtree Corners
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists Inc.
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group LLC
state: Indiana
city: Lexington
country: United States
facility: Central Kentucky Research Associates Inc.
state: Kentucky
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology LLC
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials Inc.
state: Massachusetts
city: Rochester
country: United States
facility: Remidica LLC
state: Michigan
city: Billings
country: United States
facility: Montana Health Research Institute Inc.
state: Montana
city: La Vista
country: United States
facility: Barrett Clinic P.C.
state: Nebraska
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln PC
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group LLC
state: New Jersey
city: Englewood
country: United States
facility: Urologic Research and Consulting LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Clinical Research LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: AccumetRx Clinical Research - Division of Urology Group of New Mexico
state: New Mexico
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research Inc.
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte LLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Buckeye Health and Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners
state: Ohio
city: Englewood
country: United States
facility: HWC Womens Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth Inc. - New Venture Medical Research
state: Ohio
city: Willoughby Hills
country: United States
facility: Ohio Clinical Research LLC
state: Ohio
city: Indiana
country: United States
facility: Leonard Maliver MD Antria, Inc.
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists Hills ObGyn Associates Inc
state: Pennsylvania
city: East Providence
country: United States
facility: Greater Providence Clinical Research, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Fort Mill
country: United States
facility: Piedmont Research Partners
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook LLC
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research LLC
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research, Inc.
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson Gynecology and Obstetrics
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch Inc.
state: Texas
city: DeSoto
country: United States
facility: WR Global Medical Research
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc.
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research LLC
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc.
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research
state: Washington
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
Study officials:
References:
citation: Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). J Urol. 2021 May;205(5):1421-1429. doi: 10.1097/JU.0000000000001574. Epub 2020 Dec 28.