Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
NCT ID: NCT04103450
Last Updated: 2024-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2019-09-19
2022-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vibegron
Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).
Vibegron
oral administration
Interventions
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Vibegron
oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
MALE
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Urovant Sciences
Locations
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Private Practice
Huntsville, Alabama, United States
Clinical Trials Research
Lincoln, California, United States
American Institute of Research
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Northern California Research Corp
Sacramento, California, United States
San Diego Clinical Trials
San Diego, California, United States
Skyline Urology
Torrance, California, United States
Imagine Research of Palm Beach County - Urology
Boynton Beach, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Quantum Clinical Trials
Miami, Florida, United States
Urology Center Of Florida
Pompano Beach, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
DelRicht Research
New Orleans, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Boston Clinical Trials Inc - Urology
Boston, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beaumont Hospital Royal Oak - Urology Research
Royal Oak, Michigan, United States
CentraCare Clinic - Adult & Pediatric Urology
Sartell, Minnesota, United States
Poplar Bluff Urology
Poplar Bluff, Missouri, United States
Adult & Pediatric Urology P.C. - Urology
Omaha, Nebraska, United States
Excel Clinical Research - Internal Medicine
Las Vegas, Nevada, United States
Private Practice
Las Vegas, Nevada, 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
Clinical Research Solutions
Middleburg Heights, Ohio, United States
Advances In Health, Inc.
Houston, Texas, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, United States
Seattle Urology Research Center
Burien, Washington, United States
Centrum Medyczne Linden
Krakow, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
Medicome Sp. z o.o.
Oświęcim, , Poland
Nzoz Heureka
Piaseczno, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003136-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
URO-901-3006
Identifier Type: -
Identifier Source: org_study_id
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