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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vibegron
placebos
Tolterodine Tartrate ER
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 completed participation in study RVT-901-3003.
  2. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.

Exclusion Criteria:

  1. Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
  2. Has coronary or neurovascular interventions planned during the duration of the study.
  3. Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
  4. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute.
  5. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
  6. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003.
  7. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
  8. Use of any prohibited medications as detailed in Section 7.7.3.
  9. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
  10. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
  11. Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-3003.
  12. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
  13. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.

Sites / Locations

  • Coastal Clinical Research Inc.
  • Clinical Research Consortium
  • Noble Clinical Research
  • Hope Clinical Research
  • Core Healthcare Group
  • American Clinical Trials
  • Grossmont Center for Clinical Research
  • Prime-Care Clinical Research
  • Long Beach Clinical Trials LLC
  • Downtown L.A. Research Center Inc.
  • Tri Valley Urology Medical Group
  • Northern California Research
  • Artemis Institute for Clinical Research
  • WR MCCCR
  • Artemis Institute for 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
  • PAB Clinical Research
  • Top Medical Research Inc.
  • Revival Research
  • Riverside Clinical Research
  • Indago Research Health Center
  • Best Quality 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
  • Clinical Research of West Florida
  • Clinical Research of Central Florida
  • In-Quest Medical Research, LLC
  • North Georgia Clinical Research
  • Advanced Clinical Research
  • Evanston Premier Healthcare Research
  • Clinical Investigation Specialists Inc.
  • Investigators Research Group LLC
  • Central Kentucky Research Associates Inc.
  • DelRicht Research
  • Regional Urology LLC
  • Boston Clinical Trials
  • Infinity Medical Research Inc.
  • Bay State Clinical Trials Inc.
  • Remidica LLC
  • Montana Health Research Institute Inc.
  • Barrett Clinic P.C.
  • Women's Clinic of Lincoln PC
  • Meridian Clinical Research LLC
  • Excel Clinical Research
  • 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
  • Upstate Clinical Research Associates LLC
  • PMG Research of Charlotte LLC
  • PharmQuest
  • PMG Research
  • 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
  • Leonard Maliver MD Antria, Inc.
  • The Clinical Trial Center LLC
  • Clinical Research of Philadelphia LLC
  • Preferred Primary Care Physicians Inc.
  • Research Protocol Management Specialists Hills ObGyn Associates Inc
  • Greater Providence Clinical Research, LLC
  • Clinical Trials of South Carolina
  • Piedmont Research Partners
  • Family Medicine of SayeBrook LLC
  • Hillcrest Clinical Research LLC
  • Palmetto Clinical Research
  • The Jackson Clinic
  • MultiSpecialty Clinical Research, Inc.
  • Adams Patterson Gynecology and Obstetrics
  • DiscoveResearch Inc.
  • WR Global Medical Research
  • Advances in Health
  • Pioneer Research Solutions
  • Protenium Clinical Research
  • Clinical Trials of Texas Inc.
  • Bandera Family Health Care
  • Wasatch Clinical Research LLC
  • Health Research of Hampton Roads Inc.
  • Seattle Urology Research
  • Seattle Women's: Health, Research, Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibegron + Placebo to match Tolterodine

Tolterodine + Placebo to match vibegron

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.

Secondary Outcome Measures

Change From Baseline (CFB) at Week 52 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 in 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 (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
CFB at Week 52 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 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 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed.
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
The number of urgency episodes is defined as the number of times a participant had checked "need to urinate immediately" on a CDD divided by the number of CDDs in 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of "urge," "stress," or "other." CFB was 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour.

Full Information

First Posted
June 28, 2018
Last Updated
February 19, 2021
Sponsor
Urovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03583372
Brief Title
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
Acronym
Empowur
Official Title
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term 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
June 14, 2018 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
July 25, 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 participants with OAB for up to 52 weeks.

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
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibegron + Placebo to match Tolterodine
Arm Type
Experimental
Arm Title
Tolterodine + Placebo to match vibegron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vibegron
Other Intervention Name(s)
RVT-901, MK-4618, KRP114V
Intervention Description
single daily dose 75 mg
Intervention Type
Drug
Intervention Name(s)
placebos
Intervention Description
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Intervention Type
Drug
Intervention Name(s)
Tolterodine Tartrate ER
Other Intervention Name(s)
Mariosea XL
Intervention Description
single daily dose of 4 mg
Primary Outcome Measure Information:
Title
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
Description
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
Time Frame
up to 56 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline (CFB) at Week 52 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 in 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 (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
Time Frame
Baseline; Week 52
Title
CFB at Week 52 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 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 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed.
Time Frame
Baseline; Week 52
Title
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
Description
The number of urgency episodes is defined as the number of times a participant had checked "need to urinate immediately" on a CDD divided by the number of CDDs in 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
Time Frame
Baseline; Week 52
Title
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
Description
The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of "urge," "stress," or "other." CFB was 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 MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour.
Time Frame
Baseline; Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has completed participation in study RVT-901-3003. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003. Exclusion Criteria: Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest. Has coronary or neurovascular interventions planned during the duration of the study. Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003. Use of any prohibited medications as detailed in Section 7.7.3. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant. 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 of signing informed consent, not including participation in study RVT-901-3003. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
Facility Information:
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
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
American Clinical Trials
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
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 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
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
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
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
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Top Medical Research Inc.
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
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
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
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
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
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
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189-4255
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
Central Kentucky Research Associates Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Infinity Medical Research Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
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
Montana Health Research Institute Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
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
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-6209
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
Upstate Clinical Research Associates LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
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
PMG Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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
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
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
Research Protocol Management Specialists Hills ObGyn Associates Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
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
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-8106
Country
United States
Facility Name
Piedmont Research Partners
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
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
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
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
Adams Patterson Gynecology and Obstetrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120-2382
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
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
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
Wasatch Clinical Research LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33356445
Citation
Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). J Urol. 2021 May;205(5):1421-1429. doi: 10.1097/JU.0000000000001574. Epub 2020 Dec 28.
Results Reference
derived

Learn more about this trial

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

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