[Translation] A multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of 50mg Daridorexant in Chinese adult and elderly patients with insomnia
主要研究目的:
评价50 mg Daridorexant对失眠障碍患者经多导睡眠监测(PSG)测定的客观睡眠参数入睡后清醒时间(WASO)(睡眠维持指标)的疗效。
次要研究目的:
评价50 mg Daridorexant对失眠障碍患者主观睡眠参数总睡眠时间(sTST)(睡眠时长指标)和经PSG测定的客观睡眠参数睡眠潜伏期(LPS)(睡眠潜伏期指标)的疗效。
其他研究目的:
评价50 mg Daridorexant对失眠障碍患者主观睡眠参数入睡后清醒时间(sWASO)(睡眠维持指标)和主观睡眠潜伏期(sLSO)(睡眠潜伏期指标)和经PSG测定的客观睡眠参数总睡眠时间(TST)(睡眠时长指标)的疗效等。
评价失眠障碍患者服药后的血浆浓度。
探索性目的:
探索50mg Daridorexant对失眠障碍受试者健康状态量表EQ-5D-5L的影响。
评价暴露-反应关系。
安全性目的:
评估治疗期间和治疗终止后Daridorexant在失眠障碍受试者中的安全性和耐受性。
[Translation] Main research purposes:
To evaluate the effect of 50 mg Daridorexant on the objective sleep parameters measured by polysomnography (PSG) wake time after sleep onset (WASO) (sleep maintenance index) in patients with insomnia disorders.
Secondary research purposes:
To evaluate the efficacy of 50 mg Daridorexant on the subjective sleep parameter total sleep time (sTST) (sleep duration index) and the objective sleep parameter sleep latency (LPS) measured by PSG (sleep latency index) in patients with insomnia disorders.
Other research purposes:
To evaluate the effect of 50 mg Daridorexant on the subjective sleep parameters wake-up time after sleep onset (sWASO) (sleep maintenance index) and subjective sleep latency (sLSO) (sleep latency index) in patients with insomnia disorders and the objective sleep parameters measured by PSG total sleep time (TST) ( sleep duration index), etc.
Evaluation of plasma concentrations in patients with insomnia disorders.
Exploratory purpose:
To explore the effect of 50mg Daridorexant on the health status scale EQ-5D-5L in subjects with insomnia disorders.
Evaluate the exposure-response relationship.
Security purpose:
To evaluate the safety and tolerability of daridorexant in subjects with insomnia disorders during and after treatment discontinuation.