A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)
NCT ID: NCT03492281
Last Updated: 2021-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1530 participants
INTERVENTIONAL
2018-03-26
2019-02-04
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 oral dose of vibegron 75 mg for 12 weeks
Tolterodine placebo
placebo to match tolterodine (active comparator)
Placebo to match vibegron + Placebo to match Tolterodine
Vibegron placebo
placebo to match vibegron (experimental drug)
Tolterodine placebo
placebo to match tolterodine (active comparator)
Tolterodine + Placebo to match vibegron
Vibegron placebo
placebo to match vibegron (experimental drug)
Tolterodine Tartrate ER
single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
Interventions
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vibegron
single daily oral dose of vibegron 75 mg for 12 weeks
Vibegron placebo
placebo to match vibegron (experimental drug)
Tolterodine Tartrate ER
single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
Tolterodine placebo
placebo to match tolterodine (active comparator)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meets either the OAB Wet or OAB Dry criteria.
Exclusion Criteria
1. Patient had an average total daily urine volume \> 3000 mL in the past 6 months or during the 14-day Run-in Period.
2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.
6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.
7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
8. Has an active or recurrent (\> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
9. Has a requirement for an indwelling catheter or intermittent catheterization.
10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
11. 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) or, if in the opinion of the Investigator, is uncontrolled.
12. Has evidence of diabetes insipidus.
13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
15. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) \> 100 beats per minute.
16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
17. Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions \[e.g., angioplasty, stent insertion\]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.
18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
19. Has hematuria, including microscopic hematuria according to pre-defined criteria.
20. Has clinically significant electrocardiogram (ECG) abnormality.
21. 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).
22. Has an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2.
23. 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.
24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.
18 Years
ALL
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Central Alabama Research
Birmingham, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Fundamental Research LLC
Gulf Shores, Alabama, United States
Longwood Research
Huntsville, Alabama, United States
Coastal Clinical Research Inc.
Mobile, Alabama, United States
Clinical Research Consortium
Tempe, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Dream Team Clinical Research LLC
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
Core Healthcare Group
Cerritos, California, United States
Research Center of Fresno Inc.
Fresno, California, United States
American Clinical Trials
Hawaiian Gardens, California, United States
Marvel Clinical Research
Huntington Beach, 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 Trial Services Inc.
Long Beach, California, United States
Long Beach Clinical Trials LLC
Long Beach, California, United States
Downtown L.A. Research Center Inc.
Los Angeles, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Northern California Research
Sacramento, California, United States
San Bernadino Urological Associates
San Bernardino, 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
Empire Clinical Research
Upland, 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
Innovative Medical Research of South Florida Inc.
Aventura, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Innovative Research of West FL Inc.
Clearwater, Florida, United States
Universal Medical and Research Center LLC
Coral Gables, Florida, United States
Top Medical Research Inc.
Cutler Bay, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Jesscan Medical Research
Delray Beach, Florida, United States
Revival Research
Doral, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
KO Clinical Research
Fort Lauderdale, Florida, United States
A.G.A Clinical Trials
Hialeah, Florida, United States
Indago Research Health Center
Hialeah, Florida, United States
Best Quality Research, Inc.
Hialeah, Florida, United States
Vital Pharm 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
Meridien Research
Spring Hill, Florida, United States
Pinellas Urology
St. Petersburg, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Bioclinica Research
The Villages, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, United States
Meridian Clinical Research LLC
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, 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
MediSphere Medical Research Center
Evansville, Indiana, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Central Kentucky Research Associates Inc.
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Centex Studies Inc.
Lake Charles, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Regional Urology LLC
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
BTC of New Bedford
New Bedford, Massachusetts, United States
Regeneris Medical
North Attleboro, Massachusetts, United States
Infinity Medical Research Inc.
North Dartmouth, Massachusetts, United States
Beacon Clinical Research
Quincy, Massachusetts, United States
Bay State Clinical Trials Inc.
Watertown, Massachusetts, United States
Remidica LLC
Rochester, Michigan, United States
Saginaw Valley Medical Research
Saginaw, Michigan, United States
CentraCare Clinic Adult & Pediatric Urology
Sartell, Minnesota, United States
Poplar Bluff Urology
Poplar Bluff, Missouri, United States
Montana Health Research Institute Inc.
Billings, Montana, United States
Montana Medical Research
Missoula, Montana, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 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
Adult and Pediatric Urology P.C.
Omaha, Nebraska, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Sheldon Freedman MD Ltd
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, 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
Smart Medical Research Inc.
Jackson Heights, New York, United States
ProHealth Care AssociatesLLP
Port Jefferson, New York, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Upstate Clinical Research Associates LLC
Williamsville, New York, United States
PMG Research of Cary
Cary, North Carolina, United States
PMG Research of Charlotte LLC
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Raleigh Medical Group PMG Research of Raleigh
Raleigh, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research
Wilmington, North Carolina, United States
Carolina Medical Trials LLC
Winston-Salem, 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
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Leonard Maliver MD Antria, Inc.
Indiana, Pennsylvania, United States
The Clinical Trial Center LLC
Jenkintown, Pennsylvania, United States
Green and Seidner Family Practice Associates P.C.
Lansdale, Pennsylvania, United States
Clinical Research of Philadelphia LLC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States
Research Protocol Management Specialists Hills ObGyn Associates Inc
Pittsburgh, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Uniontown, Pennsylvania, United States
PEAK Research LLC
Upper Saint Clair, Pennsylvania, United States
Greater Providence Clinical Research, LLC
East Providence, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Pharmacorp Clinical Trials Inc.
Charleston, South Carolina, United States
Piedmont Research Partners
Fort Mill, South Carolina, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
PMG Research of Charleston LLC
Moncks Corner, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
PMG Research of Charleston LLC
Mt. Pleasant, South Carolina, United States
Family Medicine of SayeBrook LLC
Myrtle Beach, South Carolina, United States
Palmetto Institute of Clinical Research Inc.
Pelzer, South Carolina, United States
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
PMG Research of Bristol LLC
Bristol, Tennessee, United States
WR - ClinSearch LLC
Chattanooga, Tennessee, United States
The Jackson Clinic
Jackson, Tennessee, United States
MultiSpecialty Clinical Research, Inc.
Johnson City, Tennessee, United States
Volunteer Research Group - NOCCR
Knoxville, Tennessee, United States
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, United States
Clinical Research Associates Inc.
Nashville, Tennessee, United States
DiscoveResearch Inc.
Bryan, Texas, United States
WR Global Medical Research
DeSoto, Texas, United States
Advances in Health
Houston, Texas, United States
Centex Studies Inc.
Houston, Texas, United States
Discovery MM Services Inc.
Houston, Texas, United States
BI Research Center
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Discovery MM Services Inc.
Katy, Texas, United States
Discovery MM Services Inc.
Missouri City, Texas, United States
Village Health Partners ACRC Trials
Plano, Texas, United States
Clinical Trials of Texas Inc.
San Antonio, Texas, United States
Bandera Family Health Care
San Antonio, Texas, United States
Clinova Clinical Trials
Spring, Texas, United States
Progressive Clinical Research
Bountiful, Utah, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Millennium Clinical Trials
Arlington, Virginia, 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
North Spokane Womens Health
Spokane, Washington, United States
Central Alberta Research Clinic
Red Deer, Alberta, Canada
Silverado Research Inc.
Victoria, British Columbia, Canada
PrimeHealth Clinical Research
Toronto, Ontario, Canada
Manna Research (Quebec)
Lévis, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Manna Research (Montreal)
Montreal, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
Csongrád, , Hungary
Szent Anna Private Surgery
Debrecen, , Hungary
Mediroyal Prevention Center
Kecskemét, , Hungary
Uro-clin Ltd
Pécs, , Hungary
Daugavpils Regional Hospital
Daugavpils, , Latvia
Uro Ltd.
Riga, , Latvia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Public Institution Republican Klaipda Hospital
Klaipėda, , Lithuania
Vilnius
Vilnius, , Lithuania
Vilnius city Clinical hospital
Vilnius, , Lithuania
Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, Woj. Dolnoslaskie, Poland
ETG Lodz
Lodz, Woj. Lodzkie, Poland
NZOZ NOVITA Specjalistyczne Gabinety Lekarskie
Lublin, Woj. Lubelskie, Poland
Nzoz Heureka
Piaseczno, Woj. Mazowieckie, Poland
Klimed Marek Klimkiewicz
Bialystok, Woj. Podlaskie, Poland
NZOZ Centrum Urologiczne sp. z o.o.
Mysłowice, Woj. Slaskie, Poland
Countries
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References
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Staskin D, Frankel J, Gregg SG, Varano S, Owens-Grillo J. Plain language summary of safety and symptom improvement with vibegron in people with overactive bladder: results from the EMPOWUR study. J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0043. Epub 2023 Aug 10.
Frankel J, Staskin D, Varano S, Newman DK, Gregg SG, Owens-Grillo J. Plain language summary: does treatment with vibegron result in improvements in overactive bladder (OAB) symptoms that are meaningful to people with OAB? J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0049. Epub 2023 Aug 10.
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Newman DK, Thomas E, Greene H, Haag-Molkenteller C, Varano S. Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial. Urogynecology (Phila). 2023 Jan 1;29(1):48-57. doi: 10.1097/SPV.0000000000001258. Epub 2022 Oct 21.
Staskin D, Frankel J, Varano S, Kennelly M, Newman DK, Rosenberg MT, Shortino DD, Jankowich RA, Mudd PN Jr. Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial. Int J Clin Pract. 2022 Apr 13;2022:6475014. doi: 10.1155/2022/6475014. eCollection 2022.
Frankel J, Staskin D, Varano S, Kennelly M, Newman DK, Rosenberg MT, Jankowich RA, Shortino D, Mudd PN Jr, Girman CJ. Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR. Adv Ther. 2022 Feb;39(2):959-970. doi: 10.1007/s12325-021-01972-8. Epub 2021 Dec 18.
Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in Patients Aged >/=65 and >/=75 Years: Subpopulation Analysis from the EMPOWUR Randomized, International, Phase III Study. Drugs Aging. 2021 Feb;38(2):137-146. doi: 10.1007/s40266-020-00829-z. Epub 2021 Jan 20.
Frankel J, Varano S, Staskin D, Shortino D, Jankowich R, Mudd PN Jr. Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study. Int J Clin Pract. 2021 May;75(5):e13937. doi: 10.1111/ijcp.13937. Epub 2021 Jan 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003293-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RVT-901-3003
Identifier Type: -
Identifier Source: org_study_id
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