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)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2022
  • participants needed
    1088
  • sponsor
    Urovant Sciences GmbH
Updated on 28 February 2021
cancer
benign prostatic hypertrophy
alpha blocker
nocturia
micturition chart
vibegron

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.

Details
Condition bladder disorder, Overactive Bladder, Bladder Disorders
Treatment Placebo, vibegron
Clinical Study IdentifierNCT03902080
SponsorUrovant Sciences GmbH
Last Modified on28 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 45 yrs?
Are you male?
Do you have any of these conditions: Bladder Disorders or bladder disorder or Overactive Bladder?
Do you have any of these conditions: bladder disorder or Bladder Disorders or Overactive Bladder?
Do you have any of these conditions: bladder disorder or Overactive Bladder or Bladder Disorders?
Do you have any of these conditions: Overactive Bladder or bladder disorder or Bladder Disorders?
Do you have any of these conditions: Bladder Disorders or Overactive Bladder or bladder disorder?
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

Exclusion Criteria

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
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