Clinical trial NCT04103450: Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Benign Prostatic Hyperplasia
Vibegron
Beta-3 adrenergic receptor (β3-AR)
β3-AR agonist
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 276
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Long-term extension
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Hematology Parameters
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Chemistry Parameters
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Urinary Parameters
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Coagulation Parameter
timeFrame: Up to Week 52
measure: Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
timeFrame: Baseline; Week 52
measure: Change From Baseline in Heart Rate
timeFrame: Baseline; Week 52
Secondary outcomes:
measure: Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day
timeFrame: Baseline; Week 52
measure: Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day
timeFrame: Baseline; Week 52
measure: Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night
timeFrame: Baseline; Week 52
measure: Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence
timeFrame: Baseline; Week 52
measure: Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
timeFrame: Baseline; Week 52
measure: Change From Baseline at Week 52 in the Average Volume Voided Per Micturition
timeFrame: Baseline; Week 52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Private Practice
state: Alabama
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Torrance
country: United States
facility: Skyline Urology
state: California
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County - Urology
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Miami
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Pompano Beach
country: United States
facility: Urology Center Of Florida
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials Inc - Urology
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital Royal Oak - Urology Research
state: Michigan
city: Sartell
country: United States
facility: CentraCare Clinic - Adult & Pediatric Urology
state: Minnesota
city: Poplar Bluff
country: United States
facility: Poplar Bluff Urology
state: Missouri
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C. - Urology
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research - Internal Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Private Practice
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group, LLC
state: New Jersey
city: Englewood
country: United States
facility: New Jersey Urology NJU
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island
state: New York
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research LLC
state: Utah
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Krakow
country: Poland
facility: Centrum Medyczne Linden
city: Krakow
country: Poland
facility: Centrum Medyczne PROMED
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
city: Piaseczno
country: Poland
facility: Nzoz Heureka
Study officials:
affiliation: Urovant Sciences
name: Study Director
role: STUDY_DIRECTOR
References: