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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID: NCT03902080
Run by: Urovant Sciences GmbH
People needed: 1105
Starts: 2019-03-26
Expected to finish: 2023-06-15
Last updated by the study team: 2024-08-07

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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 < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
Participant must have a post void residual volume value of < 100 mL
Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.

You may not qualify if…

Participant has a history of 24-hour urine volume greater than 3,000 mL
Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
Has a history of or current nocturnal polyuria
Has an active or recurrent (> 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

Where it is running

Private Practice — Huntsville, Alabama, United States
Coastal Clinical Research, Inc. — Mobile, Alabama, United States
Gen1 Research- Arizona Urology Specialists — Glendale, Arizona, United States
Urological Associates Of Southern Arizona — Tucson, Arizona, United States
California Research Medical Group, Inc. — Fullerton, California, United States
San Diego Clinical Trials — La Mesa, California, United States
Clinical Trials Research — Lincoln, California, United States
West Coast Urology — Los Alamitos, California, United States
American Institute of Research — Los Angeles, California, United States
Norris Comprehensive Cancer Center — Los Angeles, California, United States
Tri Valley Urology Medical Group — Murrieta, California, United States
Northern California Research Corp — Sacramento, California, United States
Medical Center for Clinical Research — San Diego, California, United States
Urology Specialists of Southern California (USSC) — Sherman Oaks, California, United States
Skyline Urology — Torrance, California, United States
Urology Associates - Urology — Denver, Colorado, United States
Imagine Research of Palm Beach County - Urology — Boynton Beach, Florida, United States
Tampa Bay Medical Research — Clearwater, Florida, United States
Urological Research Network Corp — Hialeah, Florida, United States
LCC Medical Research Institute — Miami, Florida, United States
Quantum Clinical Trials — Miami, Florida, United States
Private Practice — Orlando, Florida, United States
Urology Center Of Florida — Pompano Beach, Florida, United States
Pinellas Urology, Inc. — St. Petersburg, Florida, United States
Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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