Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia

Last updated: July 29, 2024
Sponsor: Urovant Sciences GmbH
Overall Status: Completed

Phase

3

Condition

Overactive Bladder

Prostate Disorders

Enuresis

Treatment

Vibegron

Clinical Study ID

NCT04103450
URO-901-3006
2018-003136-72
  • Ages > 45
  • Male

Study Summary

This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has completed participation of the 24-week double-blind treatment periodin Study URO-901-3005 (NCT03902080) and demonstrated compliance with the studyprocedures and study medication schedule in the opinion of the investigator.

  • Participant is capable of giving written informed consent, which includes compliancewith the requirements and restrictions listed in the consent form.

  • Participant has the ability to continue to receive a stable dose of Benign ProstaticHyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alphablocker +5-ARI.

  • In the opinion of the investigator, the participant is able and willing to complywith the requirements of the protocol, including completing study questionnaires andthe Bladder Diary.

Exclusion

Exclusion Criteria:

  • Participant experienced any Serious Adverse Event in Study URO-901-3005 that wasreported as "possibly or probably related" to study treatment by the investigator.

  • Participant is using any prohibited medications

  • Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/ornon-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent availablelab results in Study URO-901-3005 or uncontrolled in the opinion of theinvestigator.

  • Participant has uncontrolled hypertension (systolic blood pressure of ≥180millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has aresting heart rate (by pulse) >100 beats per minute.

  • Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed bythe investigator as safe to proceed in this study and able to complete the study perprotocol.

  • Participant has current evidence of any clinically significant condition, therapy,lab abnormality, or other circumstances 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 inthe participant's best interest.

Study Design

Total Participants: 276
Treatment Group(s): 1
Primary Treatment: Vibegron
Phase: 3
Study Start date:
September 19, 2019
Estimated Completion Date:
July 29, 2022

Connect with a study center

  • Centrum Medyczne Linden

    Krakow,
    Poland

    Site Not Available

  • Centrum Medyczne PROMED

    Krakow,
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oswiecim,
    Poland

    Site Not Available

  • Nzoz Heureka

    Piaseczno,
    Poland

    Site Not Available

  • Private Practice

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Coastal Clinical Research, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • American Institute of Research

    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 Corp

    Sacramento, California 95821
    United States

    Site Not Available

  • San Diego Clinical Trials

    San Diego, California 91942
    United States

    Site Not Available

  • Urology Specialists of Southern California (USSC)

    Sherman Oaks, California 91411
    United States

    Site Not Available

  • Skyline Urology

    Torrance, California 90505
    United States

    Site Not Available

  • Urology Associates - Urology

    Denver, Colorado 80220
    United States

    Site Not Available

  • Imagine Research of Palm Beach County - Urology

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Quantum Clinical Trials

    Miami, Florida 33140
    United States

    Site Not Available

  • Urology Center Of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • First Urology

    Jeffersonville, Indiana 47130
    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 Inc - Urology

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Mens Health Boston - Urology

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Beaumont Hospital Royal Oak - Urology Research

    Royal Oak, Michigan 48703
    United States

    Site Not Available

  • CentraCare Clinic - Adult & Pediatric Urology

    Sartell, Minnesota 56377
    United States

    Site Not Available

  • Poplar Bluff Urology

    Poplar Bluff, Missouri 63901
    United States

    Site Not Available

  • Adult & Pediatric Urology P.C. - Urology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Excel Clinical Research - Internal Medicine

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Private Practice

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Premier Urology Group, LLC

    Edison, New Jersey 08837
    United States

    Site Not Available

  • New Jersey Urology NJU

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • New Jersey Urology, LLC

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • AccuMed Research Associates

    Garden City, New York 11530
    United States

    Site Not Available

  • Urological Surgeons of Long Island

    Garden City, New York 11530
    United States

    Site Not Available

  • Manhattan Research Associates

    New York, New York 10016
    United States

    Site Not Available

  • Private Practice

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina 27612
    United States

    Site Not Available

  • Southwest Urology Inc

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Clinical Research Solutions

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Advances In Health, Inc.

    Houston, Texas 77030
    United States

    Site Not Available

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Seattle Urology Research Center

    Burien, Washington 98166
    United States

    Site Not Available

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