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

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103450
• Other study ID #: URO-901-3006
• Secondary ID: 2018-003136-72
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2019
• Est. completion date: July 29, 2022

Study information

• Verified date: February 2024
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Vibegron
oral administration

Locations

Country	Name	City	State
Poland	Centrum Medyczne Linden	Krakow
Poland	Centrum Medyczne PROMED	Krakow
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Nzoz Heureka	Piaseczno
United States	Boston Clinical Trials Inc - Urology	Boston	Massachusetts
United States	Imagine Research of Palm Beach County - Urology	Boynton Beach	Florida
United States	Seattle Urology Research Center	Burien	Washington
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Premier Urology Group, LLC	Edison	New Jersey
United States	New Jersey Urology NJU	Englewood	New Jersey
United States	AccuMed Research Associates	Garden City	New York
United States	Urological Surgeons of Long Island	Garden City	New York
United States	Advances In Health, Inc.	Houston	Texas
United States	Private Practice	Huntsville	Alabama
United States	Excel Clinical Research - Internal Medicine	Las Vegas	Nevada
United States	Private Practice	Las Vegas	Nevada
United States	Clinical Trials Research	Lincoln	California
United States	American Institute of Research	Los Angeles	California
United States	Quantum Clinical Trials	Miami	Florida
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	DelRicht Research	New Orleans	Louisiana
United States	Adult & Pediatric Urology P.C. - Urology	Omaha	Nebraska
United States	Urology Center Of Florida	Pompano Beach	Florida
United States	Poplar Bluff Urology	Poplar Bluff	Missouri
United States	Beaumont Hospital Royal Oak - Urology Research	Royal Oak	Michigan
United States	Northern California Research Corp	Sacramento	California
United States	Wasatch Clinical Research LLC	Salt Lake City	Utah
United States	San Diego Clinical Trials	San Diego	California
United States	CentraCare Clinic - Adult & Pediatric Urology	Sartell	Minnesota
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Precision Clinical Research	Sunrise	Florida
United States	Skyline Urology	Torrance	California
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Clinical Research of Central Florida	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with any Adverse Event		From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Primary	Number of Participants with any Clinically Significant Clinical Laboratory Value		From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Primary	Number of Participants with any Clinically Significant Vital Sign Assessment		From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Secondary	Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day		Baseline; Week 52
Secondary	Change from Baseline at Week 52 in the Average Number of Urgency Episodes per Day		Baseline; Week 52
Secondary	Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night		Baseline; Week 52
Secondary	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		Baseline; Week 52
Secondary	Change from Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week recall)		Baseline; Week 52
Secondary	Change from Baseline at Week 52 in the Average Volume Voided per Micturition		Baseline; Week 52