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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103450
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

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).

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Vibegron Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Long-term extension
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibegron
Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).
Drug: Vibegron
oral administration
Other Names:
  • RVT-901
  • MK-4618
  • KRP-114V
  • URO-901




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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 Measures :
  1. Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day [ Time Frame: Baseline; Week 52 ]
  2. Change from Baseline at Week 52 in the Average Number of Urgency Episodes per Day [ Time Frame: Baseline; Week 52 ]
  3. Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night [ Time Frame: Baseline; Week 52 ]
  4. 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 ]
  5. 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 ]
  6. Change from Baseline at Week 52 in the Average Volume Voided per Micturition [ Time Frame: Baseline; Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103450


Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
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Study Director: Jihao Zhou, MD, PhD Urovant Sciences

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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04103450    
Other Study ID Numbers: URO-901-3006
2018-003136-72 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
Overactive Bladder
Benign Prostatic Hyperplasia
Vibegron
Beta-3 adrenergic receptor (β3-AR)
β3-AR agonist
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male