A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Change in the mean number of night-time voids
研究概览
简要总结
This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.
详细描述
Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH).
The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males ≥18 years [no upper limit]
- •Benign prostatic hyperplasia
- •Persistent nocturia despite previous lifestyle modification advice including appropriate fluid management
- •Serum sodium not below lower limit of normal prior to randomization
- •Provide signed and dated informed consent before any study-specific procedures are conducted.
- •Able to comply with the requirements of the study.
排除标准
- 未提供
研究组 & 干预措施
Fedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
干预措施: Fedovapagon 2 mg (Drug)
Placebo matched to fedovapagon
One daily dose of placebo (matched to fedovapagon) for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the mean number of night-time voids
时间窗: 12 weeks
Change in mean patient reported nocturia bother score
时间窗: 12 weeks
次要结局
- Change in mean patient reported nocturia bother score(4 weeks)
- Number and type of Adverse Events(12 weeks)
- Change in the mean number of night-time voids(4 weeks)
- Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production(2 months)
- Change in mean functional bladder capacity(2 months)
- Change in International Prostate Symptom Score (IPSS)(12 weeks)
- Change in N-QOL Score(12 weeks)