Adult men and women with either: * OAB Wet * OAB Dry MedDRA version: 20.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Sponsors
Urovant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has completed participation in study RVT-901-3003. 2. Willing and able to provide written informed consent. 3. For females of reproductive potential: Agrees to remain abstinent or use (or have their male partner use) an acceptable method of birth control (as defined in Section 5.2.1) each time the patient has intercourse until the Follow-up Visit. 4. For females of reproductive potential: Agrees not to donate ova (eggs) until at least 1 month after the last dose of Study Treatment. 5. Has demonstrated = 80% compliance with self-administration of Study Treatment in study RVT-901-3003. 6. Has completed a minimum of 4 Complete Diary Days for study RVT-901-3003 Week 12. 7. Is ambulatory and in good general physical and mental health as determined by the Investigator. 8. In the opinion of the Investigator, is able and willing to comply with the requirements of the protocol, including completing electronic versions of questionnaires, the Voiding Diary, and Voided Volume Diary (will require ability to collect, measure, and record voided volume by herself/himself using a graduated urine collection and measurement container [provided by the Sponsor, if needed]). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Was unable to complete participation in study RVT-901-3003 for any reason. 2. 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 patient’s ability to comply with study procedures, or make participation in the study not in the patient’s best interest. Includes any serious or unstable, clinically relevant change in gastrointestinal, renal, hepatic, cardiovascular, lymphatic, or psychiatric, or other medical disorder during the RVT-901-3003 study 3. Has coronary or neurovascular interventions planned during the duration of the study. 4. 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. 5. 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. a. Patients who have systolic blood pressures = 160 mm Hg or 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. 8. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003. 9. Use of any prohibited medications as detailed in Section 7.7.3. 10. 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. 11. 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. 12. 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. 13. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator. 14. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Safety Objective: To evaluate the safety and tolerability of vibegron for up to 52 weeks in patients with symptoms of overactive bladder (OAB) who previously completed treatment in study RVT-901-3003;Secondary Objective: Secondary and Exploratory Efficacy Objectives: * To evaluate the efficacy of vibegron in patients with symptoms of OAB * To evaluate the effect of vibegron on patient-perceived outcomes in patients with symptoms of OAB ;Primary end point(s): Primary Safety Endpoint: Incidence of any adverse event by system organ class and preferred term;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 52;Secondary end point(s): Secondary Endpoints: * Change from baseline (CFB) at Week 52 in average number of micturitions per 24 hours in all OAB patients * CFB at Week 52 in average number of urge urinary incontinence (UUI) episodes per 24 hours in OAB Wet patients * CFB at Week 52 in average number of urgency episodes (need to urinate immediately) over 24 hours in all OAB patients * Percent of all OAB patients with a 50% reduction from baseline in urgency episodes (need to urinate immediately) per 24 hours at Week 52 * Percent of OAB Wet patients with a 75% reduction from baseline in UUI episodes per 24 hours at Week 52 * CFB at Week 52 in average number of total urinary incontinence episodes over 24 hours in OAB Wet patients * CFB at Week 52 in average volume voided per micturition in all OAB patients * CFB at Week 52 in Coping Score from the OAB-q LF (1 week recall) in all OAB patients * CFB at Week 52 in Health-related Quality of Life (HRQL) Total Score from the OAB-q LF (1-week recall) in all OAB patients * CFB at Week 52 in Symptom Bother Score from the OAB-q-LF (1-week recall) in all OAB patients Exploratory Endpoints: * Percent of OAB Wet patients with zero UUI episodes at Week 52 * Percent of all OAB patients with average number of micturitions < 8 per 24 hours at Week 52 * Percent of OAB Wet patients with a 50% reduction from baseline in total incontinence episodes per 24 hours at Week 52 * Percent of OAB Wet patients with zero UUI episodes at Week 52 * CFB in percent of Diary Days with zero UUI episodes at Week 52 in OAB Wet patients * CFB at Week 52 in percent of dry diary days (zero UUI episodes) in OAB Wet patients * For all OAB patients with = 1 night time voids associated with urgency (NVU) at baseline, CFB at Week 52 in the average number of NVU per 24 hours * CFB at Week 52 in overall bladder symptoms based on Patient Global Impression of Severity (PGI-Severity) in all OAB patients * CFB at We | — |
Countries
Canada, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, United States
Contacts
Public ContactClinical Trial Information Contact
Urovant Sciences GmbH
Outcome results
None listed