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) - Vibegron in Men with OAB for BPH
- Conditions
- Overactive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)MedDRA version: 23.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2018-003136-72-PL
- Lead Sponsor
- rovant Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 300
1. Has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
2. Is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
3. Has ability to continue to receive a stable dose of BPH treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5-ARI.
4. In the opinion of the investigator, is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
1. Experienced any SAE in Study URO-901-3005 that was reported as possibly or probably related” to study treatment by the investigator.
2. Is using any prohibited medications as detailed in Protocol Section 10.6 (Appendix 7).
3. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 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.
4. Has uncontrolled hypertension (systolic blood pressure of = 180 mmHg and/or diastolic blood pressure of = 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
5. 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.
6. Subject 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 subject’s ability to comply with study procedures, or make participation in the study not in the subject’s best interest.
For the complete list of exclusion criteria please refer to Study Protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of vibegron when dosed for up to 52 weeks in men with OAB symptoms on pharmacological therapy for BPH who<br>previously completed treatment in study URO-901-3005. ;Secondary Objective: To assess the long-term efficacy of vibegron when dosed for up to 52 weeks in men with OAB symptoms on pharmacological therapy for BPH who previously completed treatment in Study URO-901-3005.;Primary end point(s): • Number of participants with any adverse event<br>• Number of Participants with any Clinically Significant Clinical Laboratory Value<br>• Number of Participants with any Clinically Significant Vital Sign Assessment;Timepoint(s) of evaluation of this end point: at Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change from baseline (CFB) in the average number of micturition episodes per day<br>• CFB in the average number of urgency episodes (urgency: need to urinate immediately) per day<br>• CFB in the average the number of nocturia episodes per night<br>• CFB in the average number of urge urinary incontinence episodes per day in subjects with incontinence at baseline in Study URO-901-3005<br>• CFB in the average of International Prostate Symptom Score (IPSS) 1-week recall) Storage score (1-week recall)<br>• CFB in the average volume voided per micturition;Timepoint(s) of evaluation of this end point: at Week 52