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

Overactive Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583372
• Other study ID #: RVT-901-3004
• Secondary ID: 2017-003294-33
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2018
• Est. completion date: July 25, 2019

Study information

• Verified date: February 2021
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: July 25, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Vibegron
single daily dose 75 mg
• placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
• Tolterodine Tartrate ER
single daily dose of 4 mg

Locations

Country	Name	City	State
United States	AccumetRx Clinical Research - Division of Urology Group of New Mexico	Albuquerque	New Mexico
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Montana Health Research Institute Inc.	Billings	Montana
United States	United Medical Associates	Binghamton	New York
United States	Boston Clinical Trials	Boston	Massachusetts
United States	PAB Clinical Research	Brandon	Florida
United States	Investigators Research Group LLC	Brownsburg	Indiana
United States	DiscoveResearch Inc.	Bryan	Texas
United States	Seattle Urology Research	Burien	Washington
United States	Hope Clinical Research	Canoga Park	California
United States	Core Healthcare Group	Cerritos	California
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	PMG Research of Charlotte LLC	Charlotte	North Carolina
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	Rapid Medical Research	Cleveland	Ohio
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Buckeye Health and Research	Columbus	Ohio
United States	Top Medical Research Inc.	Cutler Bay	Florida
United States	Providence Health Partners	Dayton	Ohio
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Lynn Institute of Denver	Denver	Colorado
United States	WR Global Medical Research	DeSoto	Texas
United States	Revival Research	Doral	Florida
United States	Greater Providence Clinical Research, LLC	East Providence	Rhode Island
United States	Riverside Clinical Research	Edgewater	Florida
United States	Premier Urology Group LLC	Edison	New Jersey
United States	Regional Clinical Research Inc.	Endwell	New York
United States	HWC Womens Research Center	Englewood	Ohio
United States	Urologic Research and Consulting LLC	Englewood	New Jersey
United States	Evanston Premier Healthcare Research	Evanston	Illinois
United States	Piedmont Research Partners	Fort Mill	South Carolina
United States	AccuMed Research Associates	Garden City	New York
United States	PharmQuest	Greensboro	North Carolina
United States	Clinical Investigation Specialists Inc.	Gurnee	Illinois
United States	Drug Trials America	Hartsdale	New York
United States	American Clinical Trials	Hawaiian Gardens	California
United States	Best Quality Research, Inc.	Hialeah	Florida
United States	Indago Research Health Center	Hialeah	Florida
United States	Advances in Health	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Protenium Clinical Research	Hurst	Texas
United States	Leonard Maliver MD Antria, Inc.	Indiana	Pennsylvania
United States	The Jackson Clinic	Jackson	Tennessee
United States	The Clinical Trial Center LLC	Jenkintown	Pennsylvania
United States	MultiSpecialty Clinical Research, Inc.	Johnson City	Tennessee
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Barrett Clinic P.C.	La Vista	Nebraska
United States	Prime-Care Clinical Research	Laguna Hills	California
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Lawrence OB-GYN Clinical Research LLC	Lawrenceville	New Jersey
United States	Central Kentucky Research Associates Inc.	Lexington	Kentucky
United States	Women's Clinic of Lincoln PC	Lincoln	Nebraska
United States	Long Beach Clinical Trials LLC	Long Beach	California
United States	Downtown L.A. Research Center Inc.	Los Angeles	California
United States	Adams Patterson Gynecology and Obstetrics	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Advanced Medical Research Institute	Miami	Florida
United States	AppleMed Research Group LLC	Miami	Florida
United States	LCC Medical Research Institute Inc.	Miami	Florida
United States	Miami Clinical Research	Miami	Florida
United States	Nuren Medical Research Center	Miami	Florida
United States	San Marcus Research Clinic Inc.	Miami	Florida
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Clinical Research Consulting LLC	Milford	Connecticut
United States	Coastal Clinical Research Inc.	Mobile	Alabama
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Family Medicine of SayeBrook LLC	Myrtle Beach	South Carolina
United States	Coastal Connecticut Research LLC	New London	Connecticut
United States	DelRicht Research	New Orleans	Louisiana
United States	Bayside Clinical Research	New Port Richey	Florida
United States	Suncoast Clinical Research Inc.	New Port Richey	Florida
United States	Health Research of Hampton Roads Inc.	Newport News	Virginia
United States	Meridian Clinical Research LLC	Norfolk	Nebraska
United States	Infinity Medical Research Inc.	North Dartmouth	Massachusetts
United States	Compass Research LLC	Orlando	Florida
United States	In-Quest Medical Research, LLC	Peachtree Corners	Georgia
United States	South Broward Research LLC	Pembroke Pines	Florida
United States	Clinical Research of Philadelphia LLC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Research Protocol Management Specialists Hills ObGyn Associates Inc	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Remidica LLC	Rochester	Michigan
United States	Northern California Research	Sacramento	California
United States	Wasatch Clinical Research LLC	Salt Lake City	Utah
United States	Bandera Family Health Care	San Antonio	Texas
United States	Clinical Trials of Texas Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	WR MCCCR	San Diego	California
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Regional Urology LLC	Shreveport	Louisiana
United States	Hillcrest Clinical Research LLC	Simpsonville	South Carolina
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Clinical Research of West Florida	Tampa	Florida
United States	Clinical Research Consortium	Tempe	Arizona
United States	Noble Clinical Research	Tucson	Arizona
United States	Bayview Research Group LLC	Valley Village	California
United States	Family Practice Center of Wadsworth Inc. - New Venture Medical Research	Wadsworth	Ohio
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Bay State Clinical Trials Inc.	Watertown	Massachusetts
United States	Upstate Clinical Research Associates LLC	Williamsville	New York
United States	Ohio Clinical Research LLC	Willoughby Hills	Ohio
United States	PMG Research	Wilmington	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 56 weeks
Secondary	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.	Baseline; Week 52
Secondary	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.	Baseline; Week 52
Secondary	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.	Baseline; Week 52
Secondary	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.	Baseline; Week 52