Phase 3 N=276 Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT04103450 ↗

Enrolled (actual)

276

Serious AEs

1.8%

Results posted

Aug 2024

Primary outcome: Primary: Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) — 2; 3; 17; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vibegron (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Urovant Sciences GmbH
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)	2; 3; 17; 3	—
PRIMARY Number of Participants With Clinically Significant Changes in Hematology Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Chemistry Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Urinary Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Coagulation Parameter	0; 0	—
PRIMARY Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	-1.2; 0.1; 0.2; 1.1	—
PRIMARY Change From Baseline in Heart Rate	3.3; -0.7	—
SECONDARY Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day	-2.43	—
SECONDARY Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day	-2.90	—
SECONDARY Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night	-1.01	—
SECONDARY Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence	-0.75	—
SECONDARY Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)	-3.5	—
SECONDARY Change From Baseline at Week 52 in the Average Volume Voided Per Micturition	20.56	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04103450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.