EUCTR2018-003135-30-ES进行中（未招募）1 期
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH) - Vibegron in Men with BPH with OAB
rovant Sciences GmbH0 个研究点目标入组 1,088 人开始时间: 2019年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,088
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •2. Male subjects of 45 years of age and above.
- •3. Body weight = 50 kg (inclusive).
- •4. Subject should have been on and agree to continue to stay on a stable dose of BPH treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 ARI. Subjects on alpha blockers should have started their therapy at least 3 months prior to screening and be on a stable dose at the start of screening. Subjects on a 5-ARI should have started therapy at least 6 months prior to screening and be on a stable dose at screening.
- •5. Has a history of overactive bladder symptoms (frequency of = 8 micturition episodes per day and urgency episodes of = 3 per day with or without incontinence) while taking pharmacological therapy for at least 2 months to treat LUTS due to BPH.
- •6. Subject has an IPSS total score of = 8 at Screening and Visit 3 (Baseline).
- •7. Subject has a prostate-specific antigen (PSA) level < 4 ng/mL, or if = 4 ng/mL but = 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator.
- •8. Subjects agrees to not participate in another interventional drug or device clinical trial during the study.
- •9. 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.
- •10. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, subject must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of = 8 but = 20 micturition episodes per day over the 3-day diary period, and (b) having an average of = 3 urgency episodes per day over the 3-day diary period.
- •11. Subject must have a post void residual (PVR) volume value of < 100 mL at Screening, Visit 2 (Run-In) and Visit 3 (Baseline).
- •12. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
- •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 725
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 363
排除标准
- •1. Subject has a history of 24-hour urine volume greater than 3,000 mL or over 3,000 mL based on 3-day Bladder Diary at Visit 2 (Run-In ) or Visit 3 (Baseline) visits.
- •2. Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence; including, but not limited to, bladder stones, interstitial cystitis, prostate cancer, persistent urethral stricture, urogenital tuberculosis, and urothelial tumor.
- •3. Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery, including minimally invasive prostate procedures, during the study period. Has a previous or planned pelvic radiation, low anterior resections (LAR), or any abdominoperineal resections (APR) during the study period.
- •4. Has a history of urinary retention requiring an intervention (eg, catheterization) for any reason.
- •5. Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL at Screening and Visit 3 (Baseline).
- •6. Has a history of or current nocturnal polyuria at Visit 2 (Run-In ) or Visit 3 (Baseline) visits, based on 3-day Bladder Diary. Nocturnal polyuria is defined as more than one third of the total urine output per 24 hours occurring at night time.
- •7. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (= 5 white blood cells [WBC]/hpf with presence of red blood cell [RBC] and/or a positive urine culture, defined as = 105colony forming units [CFU]/mL in 1 specimen). Subjects diagnosed with a urinary tract infection (UTI) at the Screening Visit may be treated until the infection has resolved.
- •8. Has an implanted sacral neurostimulation (SNS) or use of any posterior tibial nerve stimulation (PTNS) device.
- •9. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled.
- •10. 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.
- •11. Subjects who have systolic blood pressures = 160 mmHg but < 180 mmHg are excluded, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol; these subjects must be on stable hypertension medication for at least 3 months prior to Screening Visit.
- •For the complete list of exclusion criteria please refer to Study Protocol
研究者
相似试验
已完成
3 期
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia PatientsCTRI/2011/09/002015Pfizer Limited290
进行中（未招募）
1 期
Study to evaluate vibegron in men taking stable BPH medications who have overactive bladder symptomsOveractive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)MedDRA version: 23.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857EUCTR2018-003135-30-PTrovant Sciences GmbH1,088
进行中（未招募）
不适用
A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study ofthe Safety and Efficacy of Adefovir Dipivoxil in Children andAdolescents (Age 2 to <18) with Chronic Hepatitis BEUCTR2004-001346-33-Outside-EU/EEAGilead Sciences Inc.173
招募中
3 期
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic NeuralgiaCTRI/2011/07/001905Pfizer Limited800
已完成
不适用
Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus-E119 Non-insulin-dependent diabetes mellitus, without complications-I10 Essential (primary) hypertensionNon-insulin-dependent diabetes mellitus, without complicationsEssential (primary) hypertensionE119I10PER-096-06TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,