Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia

NCT04103450 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: URO-901-30062018-003136-72
• Study Type: interventional
• Target: 276
• Locations: 2 countries
• Sites: 35

Brief Summary

This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Benign Prostatic Hyperplasia; Vibegron; Beta-3 adrenergic receptor (β3-AR); β3-AR agonist

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)

  Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of \>5% has been reported.

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Hematology Parameters

  Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC \[total and differential\]), and red blood cells (RBC).

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Chemistry Parameters

  Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Urinary Parameters

  Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color

  Up to Week 52

• Number of Participants With Clinically Significant Changes in Coagulation Parameter

  Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).

  Up to Week 52

• Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

  Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.

  Baseline; Week 52

• Change From Baseline in Heart Rate

  Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.

  Baseline; Week 52

Secondary Outcomes (6)

• Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day

  Baseline; Week 52

• Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day

  Baseline; Week 52

• Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night

  Baseline; Week 52

• Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence

  Baseline; Week 52

• Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)

  Baseline; Week 52

Study Arms (1)

Vibegron

EXPERIMENTAL

Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).

Drug: Vibegron

Interventions

Vibegron DRUG

oral administration

Also known as: RVT-901, MK-4618, KRP-114V, URO-901

Vibegron

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
• Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
• In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.

You may not qualify if:

• Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator.
• Participant is using any prohibited medications
• Participant has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 milligrams per deciliter \[mg/dL\] or 8.33 millimoles per Liter \[mmol/L\] and/or non-fasting blood glucose \>200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator.
• Participant 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.
• Participant has systolic blood pressures ≥160 mmHg but \<180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
• Participant has current evidence of any clinically significant condition, therapy, lab 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 study procedures, or make participation in the study not in the participant's best interest.

Sponsors & Collaborators

• Urovant Sciences GmbH: lead

Study Sites (35)

Private Practice

Huntsville, Alabama, 35801, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

San Diego Clinical Trials

San Diego, California, 91942, United States

Location

Skyline Urology

Torrance, California, 90505, United States

Location

Imagine Research of Palm Beach County - Urology

Boynton Beach, Florida, 33435, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Quantum Clinical Trials

Miami, Florida, 33140, United States

Location

Urology Center Of Florida

Pompano Beach, Florida, 33060, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Boston Clinical Trials Inc - Urology

Boston, Massachusetts, 02131, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

Beaumont Hospital Royal Oak - Urology Research

Royal Oak, Michigan, 48703, United States

Location

CentraCare Clinic - Adult & Pediatric Urology

Sartell, Minnesota, 56377, United States

Location

Poplar Bluff Urology

Poplar Bluff, Missouri, 63901, United States

Location

Adult & Pediatric Urology P.C. - Urology

Omaha, Nebraska, 68114, United States

Location

Excel Clinical Research - Internal Medicine

Las Vegas, Nevada, 89109, United States

Location

Private Practice

Las Vegas, Nevada, 89144, United States

Location

Premier Urology Group, LLC

Edison, New Jersey, 08837, United States

Location

New Jersey Urology NJU

Englewood, New Jersey, 07631, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Urological Surgeons of Long Island

Garden City, New York, 11530, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

Advances In Health, Inc.

Houston, Texas, 77030, United States

Location

Wasatch Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

Seattle Urology Research Center

Burien, Washington, 98166, United States

Location

Centrum Medyczne Linden

Krakow, Poland

Location

Centrum Medyczne PROMED

Krakow, Poland

Location

Medicome Sp. z o.o.

Oświęcim, Poland

Location

Nzoz Heureka

Piaseczno, Poland

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Prostatic Hyperplasia

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Results Point of Contact

• Title: Information, Clinical Trial Results
• Organization: Urovant Sciences

info@urovant.com

949-226-6029

Study Officials

• Study Director

  Urovant Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Long-term extension

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: September 19, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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).

Locations

US (31); PL (4)