An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
NCT ID: NCT03583372
Last Updated: 2021-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
506 participants
INTERVENTIONAL
2018-06-14
2019-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vibegron + Placebo to match Tolterodine
Vibegron
single daily dose 75 mg
placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Tolterodine + Placebo to match vibegron
placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Tolterodine Tartrate ER
single daily dose of 4 mg
Interventions
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Vibegron
single daily dose 75 mg
placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Tolterodine Tartrate ER
single daily dose of 4 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research Inc.
Mobile, Alabama, United States
Clinical Research Consortium
Tempe, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
Core Healthcare Group
Cerritos, California, United States
American Clinical Trials
Hawaiian Gardens, California, United States
Grossmont Center for Clinical Research
La Mesa, California, United States
Prime-Care Clinical Research
Laguna Hills, California, United States
Long Beach Clinical Trials LLC
Long Beach, California, United States
Downtown L.A. Research Center Inc.
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Northern California Research
Sacramento, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
WR MCCCR
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Bayview Research Group LLC
Valley Village, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Lynn Institute of Denver
Denver, Colorado, United States
Clinical Research Consulting LLC
Milford, Connecticut, United States
Coastal Connecticut Research LLC
New London, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
PAB Clinical Research
Brandon, Florida, United States
Top Medical Research Inc.
Cutler Bay, Florida, United States
Revival Research
Doral, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Indago Research Health Center
Hialeah, Florida, United States
Best Quality Research, Inc.
Hialeah, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
San Marcus Research Clinic Inc.
Miami, Florida, United States
LCC Medical Research Institute Inc.
Miami, Florida, United States
Nuren Medical Research Center
Miami, Florida, United States
AppleMed Research Group LLC
Miami, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Advanced Medical Research Institute
Miami, Florida, United States
Suncoast Clinical Research Inc.
New Port Richey, Florida, United States
Bayside Clinical Research
New Port Richey, Florida, United States
Compass Research LLC
Orlando, Florida, United States
South Broward Research LLC
Pembroke Pines, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Evanston Premier Healthcare Research
Evanston, Illinois, United States
Clinical Investigation Specialists Inc.
Gurnee, Illinois, United States
Investigators Research Group LLC
Brownsburg, Indiana, United States
Central Kentucky Research Associates Inc.
Lexington, Kentucky, United States
DelRicht Research
New Orleans, Louisiana, United States
Regional Urology LLC
Shreveport, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Infinity Medical Research Inc.
North Dartmouth, Massachusetts, United States
Bay State Clinical Trials Inc.
Watertown, Massachusetts, United States
Remidica LLC
Rochester, Michigan, United States
Montana Health Research Institute Inc.
Billings, Montana, United States
Barrett Clinic P.C.
La Vista, Nebraska, United States
Women's Clinic of Lincoln PC
Lincoln, Nebraska, United States
Meridian Clinical Research LLC
Norfolk, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Premier Urology Group LLC
Edison, New Jersey, United States
Urologic Research and Consulting LLC
Englewood, New Jersey, United States
Lawrence OB-GYN Clinical Research LLC
Lawrenceville, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
AccumetRx Clinical Research - Division of Urology Group of New Mexico
Albuquerque, New Mexico, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research Inc.
Endwell, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Drug Trials America
Hartsdale, New York, United States
Upstate Clinical Research Associates LLC
Williamsville, New York, United States
PMG Research of Charlotte LLC
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
Rapid Medical Research
Cleveland, Ohio, United States
Buckeye Health and Research
Columbus, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Providence Health Partners
Dayton, Ohio, United States
HWC Womens Research Center
Englewood, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
Family Practice Center of Wadsworth Inc. - New Venture Medical Research
Wadsworth, Ohio, United States
Ohio Clinical Research LLC
Willoughby Hills, Ohio, United States
Leonard Maliver MD Antria, Inc.
Indiana, Pennsylvania, United States
The Clinical Trial Center LLC
Jenkintown, Pennsylvania, United States
Clinical Research of Philadelphia LLC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States
Research Protocol Management Specialists Hills ObGyn Associates Inc
Pittsburgh, Pennsylvania, United States
Greater Providence Clinical Research, LLC
East Providence, Rhode Island, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Piedmont Research Partners
Fort Mill, South Carolina, United States
Family Medicine of SayeBrook LLC
Myrtle Beach, South Carolina, United States
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
MultiSpecialty Clinical Research, Inc.
Johnson City, Tennessee, United States
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, United States
DiscoveResearch Inc.
Bryan, Texas, United States
WR Global Medical Research
DeSoto, Texas, United States
Advances in Health
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Clinical Trials of Texas Inc.
San Antonio, Texas, United States
Bandera Family Health Care
San Antonio, Texas, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, United States
Health Research of Hampton Roads Inc.
Newport News, Virginia, United States
Seattle Urology Research
Burien, Washington, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003294-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RVT-901-3004
Identifier Type: -
Identifier Source: org_study_id
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