An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Vibegron; placebos; Tolterodine Tartrate ER
Intervention description: single daily dose 75 mg; placebo to match vibegron (experimental drug) and tolterodine (active comparator); single daily dose of 4 mg
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        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.