A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)

Urovant Sciences

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Tolterodine Tartrate ER; Drug: Vibegron placebo; Drug: vibegron; Drug: Tolterodine placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03492281

RVT-901-3003

2017-003293-14 (EudraCT Number)

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Enrollment: 1,530 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has a history of OAB for at least 3 months prior to the Screening Visit.
2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion criteria

Urology Medical History

1. Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.
2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.
6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.
7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
8. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
9. Has a requirement for an indwelling catheter or intermittent catheterization.
10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
11. 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) or, if in the opinion of the Investigator, is uncontrolled.
12. Has evidence of diabetes insipidus.
13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
15. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
17. Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.
18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
19. Has hematuria, including microscopic hematuria according to pre-defined criteria.
20. Has clinically significant electrocardiogram (ECG) abnormality.
21. 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).
22. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
23. 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.
24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,530 participants in 3 patient groups, including a placebo group

Vibegron + Placebo to match Tolterodine

Experimental group

Treatment:

Drug: vibegron

Drug: Tolterodine placebo

Placebo to match vibegron + Placebo to match Tolterodine

Placebo Comparator group

Treatment:

Drug: Vibegron placebo

Drug: Tolterodine placebo

Tolterodine + Placebo to match vibegron

Active Comparator group

Treatment:

Drug: Vibegron placebo

Drug: Tolterodine Tartrate ER