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

Last updated: February 19, 2021
Sponsor: Urovant Sciences GmbH
Overall Status: Completed

Phase

3

Condition

Enuresis

Overactive Bladder

Treatment

N/A

Clinical Study ID

NCT03583372
RVT-901-3004
2017-003294-33
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

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 theInvestigator, confound the results of the study, interfere with the participant'sability to comply with study procedures, or make participation in the study not in theparticipant'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 8.33mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on mostrecent available lab results in study RVT-901-3003 or, if in the opinion of theInvestigator, is uncontrolled.
  4. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolicblood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats perminute.
  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 limitof normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN ifsecondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based onmost recent available lab results in study RVT-901-3003.
  7. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on mostrecent 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 7.7.5during the study that in the opinion of the investigator is assessed to be clinicalsignificant.
  10. Has an allergy, intolerance, or a history of a significant clinical or laboratoryadverse experience associated with any of the active or inactive components of thevibegron formulation or tolterodine formulation.
  11. Is currently participating or has participated in a study with an investigationalcompound or device within 28 days of signing informed consent, not includingparticipation in study RVT-901-3003.
  12. Has a history of significant drug or alcohol abuse/dependence within a year ofinformed consent, as assessed by the investigator.
  13. Has a varying sleep schedule anticipated during times when the voiding diaries are tobe completed.

Study Design

Total Participants: 506
Study Start date:
June 14, 2018
Estimated Completion Date:
July 25, 2019

Connect with a study center

  • Central Alberta Research Clinic

    Red Deer, Alberta T4N 6V7
    Canada

    Site Not Available

  • Fundamental Research LLC

    Gulf Shores, Alabama 36542-2856
    United States

    Site Not Available

  • Longwood Research

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Coastal Clinical Research Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Clinical Research Consortium

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Hope Clinical Research

    Canoga Park, California 91303
    United States

    Site Not Available

  • Core Healthcare Group

    Cerritos, California 90703
    United States

    Site Not Available

  • American Clinical Trials

    Hawaiian Gardens, California 90716
    United States

    Site Not Available

  • Grossmont Center for Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Prime-Care Clinical Research

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Long Beach Clinical Trials LLC

    Long Beach, California 90806
    United States

    Site Not Available

  • Downtown L.A. Research Center Inc.

    Los Angeles, California 90017
    United States

    Site Not Available

  • Tri Valley Urology Medical Group

    Murrieta, California 92562
    United States

    Site Not Available

  • Northern California Research

    Sacramento, California 95821
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • WR MCCCR

    San Diego, California 92108
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Marcos, California 92078
    United States

    Site Not Available

  • Bayview Research Group LLC

    Valley Village, California 91607-3456
    United States

    Site Not Available

  • Horizons Clinical Research Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • Lynn Institute of Denver

    Denver, Colorado 80246
    United States

    Site Not Available

  • Clinical Research Consulting LLC

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Coastal Connecticut Research LLC

    New London, Connecticut 06320
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • PAB Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Top Medical Research Inc.

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Avail Clinical Research

    DeLand, Florida 32720
    United States

    Site Not Available

  • Revival Research

    Doral, Florida 33122
    United States

    Site Not Available

  • Riverside Clinical Research

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Best Quality Research, Inc.

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Indago Research Health Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Health Awareness, Inc.

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Advanced Medical Research Institute

    Miami, Florida 33174
    United States

    Site Not Available

  • AppleMed Research Group LLC

    Miami, Florida 33155
    United States

    Site Not Available

  • LCC Medical Research Institute Inc.

    Miami, Florida 33126
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Nuren Medical Research Center

    Miami, Florida 33144
    United States

    Site Not Available

  • San Marcus Research Clinic Inc.

    Miami, Florida 33015
    United States

    Site Not Available

  • Bayside Clinical Research

    New Port Richey, Florida 34655
    United States

    Site Not Available

  • Suncoast Clinical Research Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Compass Research LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • South Broward Research LLC

    Pembroke Pines, Florida 33027
    United States

    Site Not Available

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33603
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • In-Quest Medical Research, LLC

    Peachtree Corners, Georgia 30071
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189-4255
    United States

    Site Not Available

  • Elite Clinical Trials

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Advanced Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Evanston Premier Healthcare Research

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Clinical Investigation Specialists Inc.

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Investigators Research Group LLC

    Brownsburg, Indiana 46112
    United States

    Site Not Available

  • Heartland Research Associates LLC

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Central Kentucky Research Associates Inc.

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Regional Urology LLC

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Infinity Medical Research Inc.

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Bay State Clinical Trials Inc.

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Remidica LLC

    Rochester, Michigan 48307-1318
    United States

    Site Not Available

  • Montana Health Research Institute Inc.

    Billings, Montana 59102
    United States

    Site Not Available

  • Barrett Clinic P.C.

    La Vista, Nebraska 68128
    United States

    Site Not Available

  • Women's Clinic of Lincoln PC

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Meridian Clinical Research LLC

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Quality Clinical Research Inc.

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109-6209
    United States

    Site Not Available

  • Premier Urology Group LLC

    Edison, New Jersey 08837
    United States

    Site Not Available

  • Urologic Research and Consulting LLC

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Lawrence OB-GYN Clinical Research LLC

    Lawrenceville, New Jersey 08648-2526
    United States

    Site Not Available

  • AccumetRx Clinical Research - Division of Urology Group of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • United Medical Associates

    Binghamton, New York 13901
    United States

    Site Not Available

  • Regional Clinical Research Inc.

    Endwell, New York 13760
    United States

    Site Not Available

  • AccuMed Research Associates

    Garden City, New York 11530-1664
    United States

    Site Not Available

  • Drug Trials America

    Hartsdale, New York 10530
    United States

    Site Not Available

  • Upstate Clinical Research Associates LLC

    Williamsville, New York 14221-6046
    United States

    Site Not Available

  • PMG Research of Cary

    Cary, North Carolina 27518
    United States

    Site Not Available

  • PMG Research of Charlotte LLC

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PMG Research

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Sentral Clinical Research Services

    Cincinnati, Ohio 45236-2934
    United States

    Site Not Available

  • Rapid Medical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Aventiv Research, Inc.

    Columbus, Ohio 43213-6523
    United States

    Site Not Available

  • Buckeye Health and Research

    Columbus, Ohio 43207
    United States

    Site Not Available

  • Providence Health Partners

    Dayton, Ohio 45439
    United States

    Site Not Available

  • HWC Womens Research Center

    Englewood, Ohio 45322-2722
    United States

    Site Not Available

  • Clinical Research Solutions

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

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

    Wadsworth, Ohio 44281
    United States

    Site Not Available

  • Ohio Clinical Research LLC

    Willoughby Hills, Ohio 44094
    United States

    Site Not Available

  • Leonard Maliver MD Antria, Inc.

    Indiana, Pennsylvania 15701
    United States

    Site Not Available

  • The Clinical Trial Center LLC

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Clinical Research of Philadelphia LLC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Research Protocol Management Specialists Hills ObGyn Associates Inc

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Preferred Primary Care Physicians Inc.

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Greater Providence Clinical Research, LLC

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Clinical Trials of South Carolina

    Charleston, South Carolina 29406-8106
    United States

    Site Not Available

  • Piedmont Research Partners

    Fort Mill, South Carolina 29707
    United States

    Site Not Available

  • Family Medicine of SayeBrook LLC

    Myrtle Beach, South Carolina 29588
    United States

    Site Not Available

  • Hillcrest Clinical Research LLC

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • Palmetto Clinical Research

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • WR - ClinSearch LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • MultiSpecialty Clinical Research, Inc.

    Johnson City, Tennessee 37601
    United States

    Site Not Available

  • Adams Patterson Gynecology and Obstetrics

    Memphis, Tennessee 38120-2382
    United States

    Site Not Available

  • Clinical Research Associates Inc.

    Nashville, Tennessee 37203-3005
    United States

    Site Not Available

  • DiscoveResearch Inc.

    Bryan, Texas 77802-2589
    United States

    Site Not Available

  • WR Global Medical Research

    DeSoto, Texas 75115-2052
    United States

    Site Not Available

  • Advances in Health

    Houston, Texas 77030
    United States

    Site Not Available

  • Pioneer Research Solutions

    Houston, Texas 77099
    United States

    Site Not Available

  • Protenium Clinical Research

    Hurst, Texas 76054
    United States

    Site Not Available

  • Bandera Family Health Care

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Clinical Trials of Texas Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Health Research of Hampton Roads Inc.

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Seattle Urology Research

    Burien, Washington 98166
    United States

    Site Not Available

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington 98105
    United States

    Site Not Available

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