An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT03583372
- Lead Sponsor
- Urovant Sciences GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- Has completed participation in study RVT-901-3003.
- Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vibegron + Placebo to match Tolterodine placebos - Tolterodine + Placebo to match vibegron placebos - Tolterodine + Placebo to match vibegron Tolterodine Tartrate ER - Vibegron + Placebo to match Tolterodine Vibegron -
- Primary Outcome Measures
Name Time Method Number of Participants With the Indicated Type of Treatment-emergent Adverse Event up to 56 weeks 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
Name Time Method Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants Baseline; Week 52 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 Baseline; Week 52 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 Baseline; Week 52 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 Baseline; Week 52 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.
Trial Locations
- Locations (106)
Coastal Clinical Research Inc.
🇺🇸Mobile, Alabama, United States
Downtown L.A. Research Center Inc.
🇺🇸Los Angeles, California, United States
Women's Clinic of Lincoln PC
🇺🇸Lincoln, Nebraska, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Aventiv Research, Inc.
🇺🇸Columbus, Ohio, United States
Research Protocol Management Specialists Hills ObGyn Associates Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Investigators Research Group LLC
🇺🇸Brownsburg, Indiana, United States
Montana Health Research Institute Inc.
🇺🇸Billings, Montana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Meridian Clinical Research LLC
🇺🇸Norfolk, Nebraska, United States
Urologic Research and Consulting LLC
🇺🇸Englewood, New Jersey, United States
Bay State Clinical Trials Inc.
🇺🇸Watertown, Massachusetts, United States
Regional Urology LLC
🇺🇸Shreveport, Louisiana, United States
Remidica LLC
🇺🇸Rochester, Michigan, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Buckeye Health and Research
🇺🇸Columbus, Ohio, United States
Clinical Research of Philadelphia LLC
🇺🇸Philadelphia, Pennsylvania, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Seattle Urology Research
🇺🇸Burien, Washington, United States
DiscoveResearch Inc.
🇺🇸Bryan, Texas, United States
Clinical Research Solutions
🇺🇸Middleburg Heights, Ohio, United States
The Clinical Trial Center LLC
🇺🇸Jenkintown, Pennsylvania, United States
Adams Patterson Gynecology and Obstetrics
🇺🇸Memphis, Tennessee, United States
WR Global Medical Research
🇺🇸DeSoto, Texas, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
LCC Medical Research Institute Inc.
🇺🇸Miami, Florida, United States
Nuren Medical Research Center
🇺🇸Miami, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Advanced Medical Research Institute
🇺🇸Miami, Florida, United States
Advances in Health
🇺🇸Houston, Texas, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
AppleMed Research Group LLC
🇺🇸Miami, Florida, United States
Clinical Research Consortium
🇺🇸Tempe, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
American Clinical Trials
🇺🇸Hawaiian Gardens, California, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Prime-Care Clinical Research
🇺🇸Laguna Hills, California, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Long Beach Clinical Trials LLC
🇺🇸Long Beach, California, United States
Bayview Research Group LLC
🇺🇸Valley Village, California, United States
Clinical Research Consulting LLC
🇺🇸Milford, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Coastal Connecticut Research LLC
🇺🇸New London, Connecticut, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Revival Research
🇺🇸Doral, Florida, United States
Top Medical Research Inc.
🇺🇸Cutler Bay, Florida, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Best Quality Research, Inc.
🇺🇸Hialeah, Florida, United States
San Marcus Research Clinic Inc.
🇺🇸Miami, Florida, United States
Bayside Clinical Research
🇺🇸New Port Richey, Florida, United States
South Broward Research LLC
🇺🇸Pembroke Pines, Florida, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
In-Quest Medical Research, LLC
🇺🇸Peachtree Corners, Georgia, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Evanston Premier Healthcare Research
🇺🇸Evanston, Illinois, United States
Clinical Investigation Specialists Inc.
🇺🇸Gurnee, Illinois, United States
Infinity Medical Research Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Regional Clinical Research Inc.
🇺🇸Endwell, New York, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Providence Health Partners
🇺🇸Dayton, Ohio, United States
Preferred Primary Care Physicians Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Family Practice Center of Wadsworth Inc. - New Venture Medical Research
🇺🇸Wadsworth, Ohio, United States
Hillcrest Clinical Research LLC
🇺🇸Simpsonville, South Carolina, United States
Piedmont Research Partners
🇺🇸Fort Mill, South Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
MultiSpecialty Clinical Research, Inc.
🇺🇸Johnson City, Tennessee, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Suncoast Clinical Research Inc.
🇺🇸New Port Richey, Florida, United States
Indago Research Health Center
🇺🇸Hialeah, Florida, United States
Ohio Clinical Research LLC
🇺🇸Willoughby Hills, Ohio, United States
Barrett Clinic P.C.
🇺🇸La Vista, Nebraska, United States
Premier Urology Group LLC
🇺🇸Edison, New Jersey, United States
Lawrence OB-GYN Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
Upstate Clinical Research Associates LLC
🇺🇸Williamsville, New York, United States
PMG Research of Charlotte LLC
🇺🇸Charlotte, North Carolina, United States
HWC Womens Research Center
🇺🇸Englewood, Ohio, United States
PMG Research
🇺🇸Wilmington, North Carolina, United States
Leonard Maliver MD Antria, Inc.
🇺🇸Indiana, Pennsylvania, United States
Greater Providence Clinical Research, LLC
🇺🇸East Providence, Rhode Island, United States
Family Medicine of SayeBrook LLC
🇺🇸Myrtle Beach, South Carolina, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Health Research of Hampton Roads Inc.
🇺🇸Newport News, Virginia, United States
Northern California Research
🇺🇸Sacramento, California, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
WR MCCCR
🇺🇸San Diego, California, United States
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Lynn Institute of Denver
🇺🇸Denver, Colorado, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Wasatch Clinical Research LLC
🇺🇸Salt Lake City, Utah, United States
Sentral Clinical Research Services
🇺🇸Cincinnati, Ohio, United States
Clinical Trials of Texas Inc.
🇺🇸San Antonio, Texas, United States
Bandera Family Health Care
🇺🇸San Antonio, Texas, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Central Kentucky Research Associates Inc.
🇺🇸Lexington, Kentucky, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
AccumetRx Clinical Research - Division of Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States