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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vibegron
Sponsored by
Urovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Private Practice
  • Clinical Trials Research
  • American Institute of Research
  • Tri Valley Urology Medical Group
  • Northern California Research Corp
  • San Diego Clinical Trials
  • Skyline Urology
  • Imagine Research of Palm Beach County - Urology
  • Tampa Bay Medical Research
  • Quantum Clinical Trials
  • Urology Center Of Florida
  • Precision Clinical Research
  • Clinical Research of Central Florida
  • DelRicht Research
  • Regional Urology, LLC
  • Boston Clinical Trials Inc - Urology
  • Bay State Clinical Trials, Inc.
  • Beaumont Hospital Royal Oak - Urology Research
  • CentraCare Clinic - Adult & Pediatric Urology
  • Poplar Bluff Urology
  • Adult & Pediatric Urology P.C. - Urology
  • Excel Clinical Research - Internal Medicine
  • Private Practice
  • Premier Urology Group, LLC
  • New Jersey Urology NJU
  • AccuMed Research Associates
  • Urological Surgeons of Long Island
  • Clinical Research Solutions
  • Advances In Health, Inc.
  • Wasatch Clinical Research LLC
  • Seattle Urology Research Center
  • Centrum Medyczne Linden
  • Centrum Medyczne PROMED
  • Medicome Sp. z o.o.
  • Nzoz Heureka

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibegron

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with any Adverse Event
Number of Participants with any Clinically Significant Clinical Laboratory Value
Number of Participants with any Clinically Significant Vital Sign Assessment

Secondary Outcome Measures

Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day
Change from Baseline at Week 52 in the Average Number of Urgency Episodes per Day
Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night
Change from Baseline at Week 52 in the Average Number of Urge Urinary Incontinence Episodes per Day in Participants with Incontinence at Study URO-901-3005 Baseline
Change from Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week recall)
Change from Baseline at Week 52 in the Average Volume Voided per Micturition

Full Information

First Posted
September 23, 2019
Last Updated
June 1, 2023
Sponsor
Urovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04103450
Brief Title
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Official Title
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Long-term extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibegron
Arm Type
Experimental
Arm Description
Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).
Intervention Type
Drug
Intervention Name(s)
Vibegron
Other Intervention Name(s)
RVT-901, MK-4618, KRP-114V, URO-901
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Number of Participants with any Adverse Event
Time Frame
From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Title
Number of Participants with any Clinically Significant Clinical Laboratory Value
Time Frame
From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Title
Number of Participants with any Clinically Significant Vital Sign Assessment
Time Frame
From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Secondary Outcome Measure Information:
Title
Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day
Time Frame
Baseline; Week 52
Title
Change from Baseline at Week 52 in the Average Number of Urgency Episodes per Day
Time Frame
Baseline; Week 52
Title
Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night
Time Frame
Baseline; Week 52
Title
Change from Baseline at Week 52 in the Average Number of Urge Urinary Incontinence Episodes per Day in Participants with Incontinence at Study URO-901-3005 Baseline
Time Frame
Baseline; Week 52
Title
Change from Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week recall)
Time Frame
Baseline; Week 52
Title
Change from Baseline at Week 52 in the Average Volume Voided per Micturition
Time Frame
Baseline; Week 52

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Urovant Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Private Practice
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Northern California Research Corp
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Skyline Urology
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Imagine Research of Palm Beach County - Urology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Quantum Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Urology Center Of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Precision Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Boston Clinical Trials Inc - Urology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beaumont Hospital Royal Oak - Urology Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48703
Country
United States
Facility Name
CentraCare Clinic - Adult & Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Poplar Bluff Urology
City
Poplar Bluff
State/Province
Missouri
ZIP/Postal Code
63901
Country
United States
Facility Name
Adult & Pediatric Urology P.C. - Urology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Excel Clinical Research - Internal Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Private Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Premier Urology Group, LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
New Jersey Urology NJU
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Advances In Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wasatch Clinical Research LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Seattle Urology Research Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Centrum Medyczne Linden
City
Krakow
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Krakow
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oswiecim
Country
Poland
Facility Name
Nzoz Heureka
City
Piaseczno
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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).

Learn more about this trial

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

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