An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).

NCT03583372 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: RVT-901-30042017-003294-33
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 107

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Indicated Type of Treatment-emergent Adverse Event

  Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.

  up to 56 weeks

Secondary Outcomes (4)

• Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants

  Baseline; Week 52

• CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants

  Baseline; Week 52

• CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants

  Baseline; Week 52

• CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants

  Baseline; Week 52

Study Arms (2)

Vibegron + Placebo to match Tolterodine

EXPERIMENTAL

Drug: Vibegron; Drug: placebos

Tolterodine + Placebo to match vibegron

ACTIVE COMPARATOR

Drug: placebos; Drug: Tolterodine Tartrate ER

Interventions

Vibegron DRUG

single daily dose 75 mg

Also known as: RVT-901, MK-4618, KRP114V

Vibegron + Placebo to match Tolterodine

placebos DRUG

placebo to match vibegron (experimental drug) and tolterodine (active comparator)

Tolterodine + Placebo to match vibegron; Vibegron + Placebo to match Tolterodine

Tolterodine Tartrate ER DRUG

single daily dose of 4 mg

Also known as: Mariosea XL

Tolterodine + Placebo to match vibegron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Has coronary or neurovascular interventions planned during the duration of the study.
• 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.
• 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.
• Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
• 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.
• Has an estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
• Use of any prohibited medications as detailed in Section 7.7.3.
• 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.
• 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.
• 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.
• Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
• Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.

Sponsors & Collaborators

• Urovant Sciences GmbH: lead

Study Sites (107)

Coastal Clinical Research Inc.

Mobile, Alabama, 36608, United States

Location

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

American Clinical Trials

Hawaiian Gardens, California, 90716, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Prime-Care Clinical Research

Laguna Hills, California, 92653, United States

Location

Long Beach Clinical Trials LLC

Long Beach, California, 90806, United States

Location

Downtown L.A. Research Center Inc.

Los Angeles, California, 90017, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

WR MCCCR

San Diego, California, 92108, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Bayview Research Group LLC

Valley Village, California, 91607-3456, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Lynn Institute of Denver

Denver, Colorado, 80246, United States

Location

Clinical Research Consulting LLC

Milford, Connecticut, 06460, United States

Location

Coastal Connecticut Research LLC

New London, Connecticut, 06320, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Top Medical Research Inc.

Cutler Bay, Florida, 33189, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Indago Research Health Center

Hialeah, Florida, 33012, United States

Location

Best Quality Research, Inc.

Hialeah, Florida, 33016, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

San Marcus Research Clinic Inc.

Miami, Florida, 33015, United States

Location

LCC Medical Research Institute Inc.

Miami, Florida, 33126, United States

Location

Nuren Medical Research Center

Miami, Florida, 33144, United States

Location

AppleMed Research Group LLC

Miami, Florida, 33155, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Advanced Medical Research Institute

Miami, Florida, 33174, United States

Location

Suncoast Clinical Research Inc.

New Port Richey, Florida, 34652, United States

Location

Bayside Clinical Research

New Port Richey, Florida, 34655, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

South Broward Research LLC

Pembroke Pines, Florida, 33027, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

In-Quest Medical Research, LLC

Peachtree Corners, Georgia, 30071, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189-4255, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Evanston Premier Healthcare Research

Evanston, Illinois, 60201, United States

Location

Clinical Investigation Specialists Inc.

Gurnee, Illinois, 60031, United States

Location

Investigators Research Group LLC

Brownsburg, Indiana, 46112, United States

Location

Central Kentucky Research Associates Inc.

Lexington, Kentucky, 40509, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Regional Urology LLC

Shreveport, Louisiana, 71106, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Infinity Medical Research Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Bay State Clinical Trials Inc.

Watertown, Massachusetts, 02472, United States

Location

Remidica LLC

Rochester, Michigan, 48307-1318, United States

Location

Montana Health Research Institute Inc.

Billings, Montana, 59102, United States

Location

Barrett Clinic P.C.

La Vista, Nebraska, 68128, United States

Location

Women's Clinic of Lincoln PC

Lincoln, Nebraska, 68510, United States

Location

Meridian Clinical Research LLC

Norfolk, Nebraska, 68701, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109-6209, United States

Location

Premier Urology Group LLC

Edison, New Jersey, 08837, United States

Location

Urologic Research and Consulting LLC

Englewood, New Jersey, 07631, United States

Location

Lawrence OB-GYN Clinical Research LLC

Lawrenceville, New Jersey, 08648-2526, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

AccumetRx Clinical Research - Division of Urology Group of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research Inc.

Endwell, New York, 13760, United States

Location

AccuMed Research Associates

Garden City, New York, 11530-1664, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221-6046, United States

Location

PMG Research of Charlotte LLC

Charlotte, North Carolina, 28209, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

PMG Research

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Sentral Clinical Research Services

Cincinnati, Ohio, 45236-2934, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Buckeye Health and Research

Columbus, Ohio, 43207, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213-6523, United States

Location

Providence Health Partners

Dayton, Ohio, 45439, United States

Location

HWC Womens Research Center

Englewood, Ohio, 45322-2722, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

Family Practice Center of Wadsworth Inc. - New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Ohio Clinical Research LLC

Willoughby Hills, Ohio, 44094, United States

Location

Leonard Maliver MD Antria, Inc.

Indiana, Pennsylvania, 15701, United States

Location

The Clinical Trial Center LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Clinical Research of Philadelphia LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Preferred Primary Care Physicians Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

Research Protocol Management Specialists Hills ObGyn Associates Inc

Pittsburgh, Pennsylvania, 15243, United States

Location

Greater Providence Clinical Research, LLC

East Providence, Rhode Island, 02914, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406-8106, United States

Location

Piedmont Research Partners

Fort Mill, South Carolina, 29707, United States

Location

Family Medicine of SayeBrook LLC

Myrtle Beach, South Carolina, 29588, United States

Location

Hillcrest Clinical Research LLC

Simpsonville, South Carolina, 29681, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38301, United States

Location

MultiSpecialty Clinical Research, Inc.

Johnson City, Tennessee, 37601, United States

Location

Adams Patterson Gynecology and Obstetrics

Memphis, Tennessee, 38120-2382, United States

Location

DiscoveResearch Inc.

Bryan, Texas, 77802-2589, United States

Location

WR Global Medical Research

DeSoto, Texas, 75115-2052, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Pioneer Research Solutions

Houston, Texas, 77099, United States

Location

Protenium Clinical Research

Hurst, Texas, 76054, United States

Location

Clinical Trials of Texas Inc.

San Antonio, Texas, 78229, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

Wasatch Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

Health Research of Hampton Roads Inc.

Newport News, Virginia, 23606, United States

Location

Seattle Urology Research

Burien, Washington, 98166, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 33356445 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urologic Diseases; Lower Urinary Tract Symptoms

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Information, Clinical Trial Results
• Organization: Urovant Sciences

info@urovant.com

949-226-6029

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: June 14, 2018
• Primary Completion: June 13, 2019
• Study Completion: July 25, 2019
• Last Updated: March 18, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (107)