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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902080
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Vibegron Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1088 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vibegron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vibegron 75 mg
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
 Drug: Vibegron
oral administration
Other Names:
  • RVT-901
  • MK-4618
  • KRP-114V
  • URO-901
Placebo Comparator: Placebo
Participants will receive matching placebo orally once daily for 24 weeks.
 Drug: Placebo
oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline at Week 12 in the average number of micturition episodes per day [ Time Frame: Baseline; Week 12 ]
  2. Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline at Week 12 in the average number of nocturia episodes per night [ Time Frame: Baseline; Week 12 ]
  2. Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline [ Time Frame: Baseline; Week 12 ]
  3. Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall) [ Time Frame: Baseline; Week 12 ]
  4. Change from Baseline at Week 12 in the average volume voided per micturition [ Time Frame: Baseline; Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 < 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902080


Contacts
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Contact: Urovant Call Center (833) 876-8268 clinicaltrials@urovant.com

Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
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Study Director: Study Director Urovant Sciences
More Information
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Additional Information:

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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03902080    
Other Study ID Numbers: URO-901-3005
2018-003135-30 ( EudraCT Number )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
Access Criteria: Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
Overactive Bladder
Benign Prostatic Hyperplasia
Vibegron
Beta-3 adrenergic receptor (β3-AR)
β3-AR agonist
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Prostatic Diseases
Genital Diseases, Male
Genital Diseases