Phase 3
N=1,105
Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT03902080 ↗Enrolled (actual)
1,105
Serious AEs
3.6%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day — -2.04; -1.30 Micturitions per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vibegron (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Urovant Sciences GmbH
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day |
-2.04; -1.30 | <0.0001 sig |
| PRIMARY Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day |
-2.88; -1.93 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night |
-0.88; -0.66 | =0.0015 sig |
| SECONDARY Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline |
-2.19; -1.39 | =0.0034 sig |
| SECONDARY Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) |
-3.0; -2.2 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 12 in the Average Volume Voided Per Micturition |
25.63; 10.56 | <0.0001 sig |
Summary
This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.
Eligibility Criteria
Inclusion Criteria
- Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
- Participant has an International Prostate Symptom Score total score of ≥ 8
- Participant has a prostate-specific antigen level 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
- Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
- Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
- 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 alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
- Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest
Data sourced from ClinicalTrials.gov (NCT03902080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.