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A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vibegron
Vibegron placebo
Tolterodine Tartrate ER
Tolterodine placebo
Sponsored by
Urovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Beta-3 adrenergic receptor (β3-AR) agonists, Incontinence, OAB, Vibegron, Urge urinary incontinence, Urinary bladder, overactive, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has a history of OAB for at least 3 months prior to the Screening Visit.
  2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

  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.

Sites / Locations

  • Central Alabama Research
  • Achieve Clinical Research
  • Fundamental Research LLC
  • Longwood Research
  • Coastal Clinical Research Inc.
  • Clinical Research Consortium
  • Noble Clinical Research
  • Eclipse Clinical Research
  • Dream Team Clinical Research LLC
  • Hope Clinical Research
  • Core Healthcare Group
  • Research Center of Fresno Inc.
  • American Clinical Trials
  • Marvel Clinical Research
  • Grossmont Center for Clinical Research
  • Prime-Care Clinical Research
  • Long Beach Clinical Trial Services Inc.
  • Long Beach Clinical Trials LLC
  • Downtown L.A. Research Center Inc.
  • Urology Group of Southern California
  • Tri Valley Urology Medical Group
  • Northern California Research
  • San Bernadino Urological Associates
  • Artemis Institute for Clinical Research
  • WR MCCCR
  • Artemis Institute for Clinical Research
  • Empire Clinical Research
  • Bayview Research Group LLC
  • Horizons Clinical Research Center
  • Lynn Institute of Denver
  • Clinical Research Consulting LLC
  • Coastal Connecticut Research LLC
  • Chase Medical Research, LLC
  • Innovative Medical Research of South Florida Inc.
  • PAB Clinical Research
  • Innovative Research of West FL Inc.
  • Universal Medical and Research Center LLC
  • Top Medical Research Inc.
  • Avail Clinical Research
  • Jesscan Medical Research
  • Revival Research
  • Riverside Clinical Research
  • KO Clinical Research
  • A.G.A Clinical Trials
  • Indago Research Health Center
  • Best Quality Research, Inc.
  • Vital Pharm Research Inc.
  • Health Awareness, Inc.
  • San Marcus Research Clinic Inc.
  • LCC Medical Research Institute Inc.
  • Nuren Medical Research Center
  • AppleMed Research Group LLC
  • Miami Clinical Research
  • Advanced Medical Research Institute
  • Suncoast Clinical Research Inc.
  • Bayside Clinical Research
  • Compass Research LLC
  • South Broward Research LLC
  • Clinical Research Center of Florida
  • Pinellas Urology
  • Meridien Research
  • Clinical Research of West Florida
  • Bioclinica Research
  • Asclepes Research Centers
  • Clinical Research of Central Florida
  • In-Quest Medical Research, LLC
  • Meridian Clinical Research LLC
  • Clinical Research Atlanta
  • North Georgia Clinical Research
  • Elite Clinical Trials
  • Advanced Clinical Research
  • Evanston Premier Healthcare Research
  • Clinical Investigation Specialists Inc.
  • Investigators Research Group LLC
  • MediSphere Medical Research Center
  • Heartland Research Associates LLC
  • Heartland Research Associates LLC
  • Central Kentucky Research Associates Inc.
  • L-MARC Research Center
  • Centex Studies Inc.
  • DelRicht Research
  • Regional Urology LLC
  • Chesapeake Urology Research Associates
  • Boston Clinical Trials
  • BTC of New Bedford
  • Regeneris Medical
  • Infinity Medical Research Inc.
  • Beacon Clinical Research
  • Bay State Clinical Trials Inc.
  • Remidica LLC
  • Saginaw Valley Medical Research
  • CentraCare Clinic Adult & Pediatric Urology
  • Poplar Bluff Urology
  • Montana Health Research Institute Inc.
  • Montana Medical Research
  • Pioneer Clinical Research, LLC
  • Barrett Clinic P.C.
  • Women's Clinic of Lincoln PC
  • Meridian Clinical Research LLC
  • Adult and Pediatric Urology P.C.
  • Quality Clinical Research Inc.
  • Excel Clinical Research
  • Clinical Research Consortium
  • Sheldon Freedman MD Ltd
  • Hassman Research Institute
  • Premier Urology Group LLC
  • Urologic Research and Consulting LLC
  • Lawrence OB-GYN Clinical Research LLC
  • Albuquerque Clinical Trials, Inc.
  • AccumetRx Clinical Research - Division of Urology Group of New Mexico
  • United Medical Associates
  • Regional Clinical Research Inc.
  • AccuMed Research Associates
  • Drug Trials America
  • Smart Medical Research Inc.
  • ProHealth Care AssociatesLLP
  • Rochester Clinical Research Inc.
  • Upstate Clinical Research Associates LLC
  • PMG Research of Cary
  • PMG Research of Charlotte LLC
  • PharmQuest
  • Peters Medical Research
  • Raleigh Medical Group PMG Research of Raleigh
  • Associated Urologists of North Carolina
  • PMG Research of Salisbury
  • PMG Research of Wilmington, LLC
  • PMG Research
  • Carolina Medical Trials LLC
  • PMG Research of Winston-Salem
  • Sentral Clinical Research Services
  • Rapid Medical Research
  • Buckeye Health and Research
  • Aventiv Research, Inc.
  • Providence Health Partners
  • HWC Womens Research Center
  • Clinical Research Solutions
  • Family Practice Center of Wadsworth Inc. - New Venture Medical Research
  • Ohio Clinical Research LLC
  • Lynn Health Science Institute
  • Leonard Maliver MD Antria, Inc.
  • The Clinical Trial Center LLC
  • Green and Seidner Family Practice Associates P.C.
  • Clinical Research of Philadelphia LLC
  • Preferred Primary Care Physicians Inc.
  • Preferred Primary Care Physicians Inc.
  • Research Protocol Management Specialists Hills ObGyn Associates Inc
  • Frontier Clinical Research, LLC
  • Preferred Primary Care Physicians Inc.
  • PEAK Research LLC
  • Greater Providence Clinical Research, LLC
  • Omega Medical Research
  • Clinical Trials of South Carolina
  • Pharmacorp Clinical Trials Inc.
  • Piedmont Research Partners
  • DeGarmo Institute of Medical Research
  • PMG Research of Charleston LLC
  • Coastal Carolina Research Center
  • PMG Research of Charleston LLC
  • Family Medicine of SayeBrook LLC
  • Palmetto Institute of Clinical Research Inc.
  • Hillcrest Clinical Research LLC
  • Palmetto Clinical Research
  • PMG Research of Bristol LLC
  • WR - ClinSearch LLC
  • The Jackson Clinic
  • MultiSpecialty Clinical Research, Inc.
  • Volunteer Research Group - NOCCR
  • Adams Patterson Gynecology and Obstetrics
  • Clinical Research Associates Inc.
  • DiscoveResearch Inc.
  • WR Global Medical Research
  • Advances in Health
  • Centex Studies Inc.
  • Discovery MM Services Inc.
  • BI Research Center
  • Pioneer Research Solutions
  • Protenium Clinical Research
  • Discovery MM Services Inc.
  • Discovery MM Services Inc.
  • Village Health Partners ACRC Trials
  • Clinical Trials of Texas Inc.
  • Bandera Family Health Care
  • Clinova Clinical Trials
  • Progressive Clinical Research
  • Wasatch Clinical Research LLC
  • Advanced Clinical Research
  • Millennium Clinical Trials
  • Health Research of Hampton Roads Inc.
  • Seattle Urology Research
  • Seattle Women's: Health, Research, Gynecology
  • North Spokane Womens Health
  • Central Alberta Research Clinic
  • Silverado Research Inc.
  • PrimeHealth Clinical Research
  • Manna Research (Quebec)
  • Recherche GCP Research
  • Manna Research (Montreal)
  • Diex Research Sherbrooke Inc.
  • Obudai Egeszsegugyi Centrum Kft.
  • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
  • Szent Anna Private Surgery
  • Mediroyal Prevention Center
  • Uro-clin Ltd
  • Daugavpils Regional Hospital
  • Uro Ltd.
  • Pauls Stradins Clinical University Hospital
  • Public Institution Republican Klaipda Hospital
  • Vilnius
  • Vilnius city Clinical hospital
  • Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia
  • ETG Lodz
  • NZOZ NOVITA Specjalistyczne Gabinety Lekarskie
  • Nzoz Heureka
  • Klimed Marek Klimkiewicz
  • NZOZ Centrum Urologiczne sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Vibegron + Placebo to match Tolterodine

Placebo to match vibegron + Placebo to match Tolterodine

Tolterodine + Placebo to match vibegron

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures are study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of micturitions, and treatment by study visit interaction. FAS=Full Analysis Set.
CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of UUI episodes and treatment by study visit interaction. FAS-I=Full Analysis Set for Incontinence.

Secondary Outcome Measures

CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants
An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of urgency episodes, and treatment by study visit interaction.
Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).
Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).
Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12
An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).
CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants
Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the par. got up for the day each morning and time the par. got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of incontinence episodes, and treatment by study visit interaction. hr = hours.
CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants
The OAB-q LF is a validated patient-reported outcome. 8 questions of the OAB-q LF ask participants how well they have coped with their bladder symptoms during the previous week, as a measure of quality of life. Each question has a response ranging from "not coping" (= 1) to "coping well" (= 6). These questions make up the coping scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants
A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL volume (milliliters [mL]), and treatment by study visit interaction.
CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants
The OAB-q LF is a validated patient-reported outcome. The 25 questions comprising the Coping, Concern, Sleep and Social Interaction subscales of the OAB-q LF ask participants how much their symptoms have affected their life over the last week. Each question has a response ranging from "None of the time" (= 1) to "All of the time" (= 6). The raw score (sum of question scores for the 4 subscales [ranging from 25 to 150]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants
The OAB-q LF is a validated patient-reported outcome. The first 8 questions of the OAB-q LF ask participants how much they were bothered by their bladder symptoms during the previous week. Each question has a response ranging from "Not at all" (= 1) to "A very great deal" (= 6). These questions make up the symptom bother scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to the symptoms having a larger bother, and lower scores represent a lower amount of bother due to symptoms. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12
A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. A participant was defined as having an average of < 8 daily micturitions if the arithmetic mean of the number of micturitions per day in the PVD was less than 8 . "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).
Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12
Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. All events marked as having leakage, regardless of cause, or where "Accidental Leakage" was checked. were used in the analysis. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD.
CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Severity score, participants are asked to rate their OAB symptoms over the previous week with one of the following responses: 1 = none, 2 = mild, 3 = moderate, 4 = severe. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.
CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Control score, participants were asked to rate how much control they had over their OAB symptoms over the previous week with one of the following responses: 1 = complete control, 2 = a lot of control, 3 = some control, 4 = only a little control, 5 = no control. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.

Full Information

First Posted
March 21, 2018
Last Updated
February 11, 2021
Sponsor
Urovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03492281
Brief Title
A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)
Acronym
Empowur
Official Title
An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibegron + Placebo to match Tolterodine
Arm Type
Experimental
Arm Title
Placebo to match vibegron + Placebo to match Tolterodine
Arm Type
Placebo Comparator
Arm Title
Tolterodine + Placebo to match vibegron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vibegron
Other Intervention Name(s)
RVT-901, MK4618, KRP114V, URO-901
Intervention Description
single daily oral dose of vibegron 75 mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vibegron placebo
Intervention Description
placebo to match vibegron (experimental drug)
Intervention Type
Drug
Intervention Name(s)
Tolterodine Tartrate ER
Other Intervention Name(s)
Mariosea XL
Intervention Description
single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tolterodine placebo
Intervention Description
placebo to match tolterodine (active comparator)
Primary Outcome Measure Information:
Title
Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
Description
A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures are study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of micturitions, and treatment by study visit interaction. FAS=Full Analysis Set.
Time Frame
Baseline (BL); Week 12
Title
CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
Description
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of UUI episodes and treatment by study visit interaction. FAS-I=Full Analysis Set for Incontinence.
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants
Description
An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of urgency episodes, and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
Description
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).
Time Frame
Baseline; Week 12
Title
Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
Description
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).
Time Frame
Baseline; Week 12
Title
Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12
Description
An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants
Description
Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the par. got up for the day each morning and time the par. got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of incontinence episodes, and treatment by study visit interaction. hr = hours.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants
Description
The OAB-q LF is a validated patient-reported outcome. 8 questions of the OAB-q LF ask participants how well they have coped with their bladder symptoms during the previous week, as a measure of quality of life. Each question has a response ranging from "not coping" (= 1) to "coping well" (= 6). These questions make up the coping scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants
Description
A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL volume (milliliters [mL]), and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants
Description
The OAB-q LF is a validated patient-reported outcome. The 25 questions comprising the Coping, Concern, Sleep and Social Interaction subscales of the OAB-q LF ask participants how much their symptoms have affected their life over the last week. Each question has a response ranging from "None of the time" (= 1) to "All of the time" (= 6). The raw score (sum of question scores for the 4 subscales [ranging from 25 to 150]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants
Description
The OAB-q LF is a validated patient-reported outcome. The first 8 questions of the OAB-q LF ask participants how much they were bothered by their bladder symptoms during the previous week. Each question has a response ranging from "Not at all" (= 1) to "A very great deal" (= 6). These questions make up the symptom bother scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to the symptoms having a larger bother, and lower scores represent a lower amount of bother due to symptoms. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12
Description
A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. A participant was defined as having an average of < 8 daily micturitions if the arithmetic mean of the number of micturitions per day in the PVD was less than 8 . "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).
Time Frame
Week 12
Title
Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12
Description
Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. All events marked as having leakage, regardless of cause, or where "Accidental Leakage" was checked. were used in the analysis. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants
Description
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Severity score, participants are asked to rate their OAB symptoms over the previous week with one of the following responses: 1 = none, 2 = mild, 3 = moderate, 4 = severe. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.
Time Frame
Baseline; Week 12
Title
CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants
Description
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Control score, participants were asked to rate how much control they had over their OAB symptoms over the previous week with one of the following responses: 1 = complete control, 2 = a lot of control, 3 = some control, 4 = only a little control, 5 = no control. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a history of OAB for at least 3 months prior to the Screening Visit. Meets either the OAB Wet or OAB Dry criteria. Exclusion Criteria: Urology Medical History Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring). Patient is currently using a pessary for the treatment of pelvic organ prolapse. Has a known history of elevated post-void residual volume defined as greater than 150 mL. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria. Has a requirement for an indwelling catheter or intermittent catheterization. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening. 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. Has evidence of diabetes insipidus. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study. 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. 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. Has narrow angle glaucoma (primary open angle glaucoma is not excluded). 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. 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. Has hematuria, including microscopic hematuria according to pre-defined criteria. Has clinically significant electrocardiogram (ECG) abnormality. 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). Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. 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 prior to signing informed consent, or has participated in any previous study with vibegron.
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Fundamental Research LLC
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542-2856
Country
United States
Facility Name
Longwood Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Research Consortium
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Eclipse Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Dream Team Clinical Research LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Research Center of Fresno Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
American Clinical Trials
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Prime-Care Clinical Research
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Long Beach Clinical Trial Services Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Long Beach Clinical Trials LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Downtown L.A. Research Center Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Urology Group of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
San Bernadino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404-4816
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
WR MCCCR
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Bayview Research Group LLC
City
Valley Village
State/Province
California
ZIP/Postal Code
91607-3456
Country
United States
Facility Name
Horizons Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Lynn Institute of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Clinical Research Consulting LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Coastal Connecticut Research LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Innovative Medical Research of South Florida Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180-1151
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Innovative Research of West FL Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Universal Medical and Research Center LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Top Medical Research Inc.
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Jesscan Medical Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Revival Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
KO Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316-2521
Country
United States
Facility Name
A.G.A Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-3407
Country
United States
Facility Name
Indago Research Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Best Quality Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Vital Pharm Research Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
San Marcus Research Clinic Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
LCC Medical Research Institute Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Nuren Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
AppleMed Research Group LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Suncoast Clinical Research Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Bayside Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
South Broward Research LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Pinellas Urology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Meridien Research
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Bioclinica Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Asclepes Research Centers
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
In-Quest Medical Research, LLC
City
Peachtree Corners
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189-4255
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Evanston Premier Healthcare Research
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Investigation Specialists Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Investigators Research Group LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
MediSphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Centex Studies Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740-2133
Country
United States
Facility Name
Regeneris Medical
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Infinity Medical Research Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Beacon Clinical Research
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Bay State Clinical Trials Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Remidica LLC
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307-1318
Country
United States
Facility Name
Saginaw Valley Medical Research
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
CentraCare Clinic Adult & Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Poplar Bluff Urology
City
Poplar Bluff
State/Province
Missouri
ZIP/Postal Code
63901-1908
Country
United States
Facility Name
Montana Health Research Institute Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Pioneer Clinical Research, LLC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Barrett Clinic P.C.
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Women's Clinic of Lincoln PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Adult and Pediatric Urology P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Quality Clinical Research Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-6209
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Sheldon Freedman MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Premier Urology Group LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Urologic Research and Consulting LLC
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Lawrence OB-GYN Clinical Research LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648-2526
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
AccumetRx Clinical Research - Division of Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Regional Clinical Research Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530-1664
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Smart Medical Research Inc.
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Facility Name
ProHealth Care AssociatesLLP
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Rochester Clinical Research Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609-3109
Country
United States
Facility Name
Upstate Clinical Research Associates LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
Country
United States
Facility Name
PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Charlotte LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Raleigh Medical Group PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609-7245
Country
United States
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Carolina Medical Trials LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4109
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-2934
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Buckeye Health and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213-6523
Country
United States
Facility Name
Providence Health Partners
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
HWC Womens Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322-2722
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Family Practice Center of Wadsworth Inc. - New Venture Medical Research
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Ohio Clinical Research LLC
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4703
Country
United States
Facility Name
Leonard Maliver MD Antria, Inc.
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
The Clinical Trial Center LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Green and Seidner Family Practice Associates P.C.
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Clinical Research of Philadelphia LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Preferred Primary Care Physicians Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Research Protocol Management Specialists Hills ObGyn Associates Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Preferred Primary Care Physicians Inc.
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
PEAK Research LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Greater Providence Clinical Research, LLC
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886-1689
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-8106
Country
United States
Facility Name
Pharmacorp Clinical Trials Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412-2625
Country
United States
Facility Name
Piedmont Research Partners
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651-1818
Country
United States
Facility Name
PMG Research of Charleston LLC
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
PMG Research of Charleston LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Family Medicine of SayeBrook LLC
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
Palmetto Institute of Clinical Research Inc.
City
Pelzer
State/Province
South Carolina
ZIP/Postal Code
29669
Country
United States
Facility Name
Hillcrest Clinical Research LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
PMG Research of Bristol LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
WR - ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
MultiSpecialty Clinical Research, Inc.
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Volunteer Research Group - NOCCR
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Adams Patterson Gynecology and Obstetrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120-2382
Country
United States
Facility Name
Clinical Research Associates Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-3005
Country
United States
Facility Name
DiscoveResearch Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802-2589
Country
United States
Facility Name
WR Global Medical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115-2052
Country
United States
Facility Name
Advances in Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centex Studies Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Discovery MM Services Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77061
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Protenium Clinical Research
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Discovery MM Services Inc.
City
Katy
State/Province
Texas
ZIP/Postal Code
77450-7587
Country
United States
Facility Name
Discovery MM Services Inc.
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
Village Health Partners ACRC Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Clinical Trials of Texas Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bandera Family Health Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Clinova Clinical Trials
City
Spring
State/Province
Texas
ZIP/Postal Code
77379
Country
United States
Facility Name
Progressive Clinical Research
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Wasatch Clinical Research LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Millennium Clinical Trials
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22207
Country
United States
Facility Name
Health Research of Hampton Roads Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Seattle Urology Research
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Womens Health
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Central Alberta Research Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Silverado Research Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 2C1
Country
Canada
Facility Name
PrimeHealth Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Manna Research (Quebec)
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M6
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Manna Research (Montreal)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
City
Csongrád
ZIP/Postal Code
6640
Country
Hungary
Facility Name
Szent Anna Private Surgery
City
Debrecen
ZIP/Postal Code
4029
Country
Hungary
Facility Name
Mediroyal Prevention Center
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Uro-clin Ltd
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Uro Ltd.
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Public Institution Republican Klaipda Hospital
City
Klaipėda
ZIP/Postal Code
92231
Country
Lithuania
Facility Name
Vilnius
City
Vilnius
ZIP/Postal Code
LT-09108
Country
Lithuania
Facility Name
Vilnius city Clinical hospital
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia
City
Wrocław
State/Province
Woj. Dolnoslaskie
ZIP/Postal Code
54-144
Country
Poland
Facility Name
ETG Lodz
City
Łódź
State/Province
Woj. Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
NZOZ NOVITA Specjalistyczne Gabinety Lekarskie
City
Lublin
State/Province
Woj. Lubelskie
ZIP/Postal Code
20-632
Country
Poland
Facility Name
Nzoz Heureka
City
Piaseczno
State/Province
Woj. Mazowieckie
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Klimed Marek Klimkiewicz
City
Białystok
State/Province
Woj. Podlaskie
ZIP/Postal Code
15-776
Country
Poland
Facility Name
NZOZ Centrum Urologiczne sp. z o.o.
City
Mysłowice
State/Province
Woj. Slaskie
ZIP/Postal Code
41-400
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35685566
Citation
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.
Results Reference
derived
PubMed Identifier
34921665
Citation
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.
Results Reference
derived
PubMed Identifier
33469832
Citation
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.
Results Reference
derived
PubMed Identifier
33332699
Citation
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.
Results Reference
derived

Learn more about this trial

A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

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