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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date08 Aug 1973 |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估KarXT在阿尔茨海默病相关的精神行为症状受试者中的长期安全性和耐受性的开放性扩展研究
[Translation] An open-label extension study to evaluate the long-term safety and tolerability of KarXT in subjects with psychiatric and behavioral symptoms associated with Alzheimer's disease
评估KarXT在AD相关的精神行为症状受试者中的长期安全性和耐受性
[Translation] To evaluate the long-term safety and tolerability of KarXT in subjects with AD-related psychiatric and behavioral symptoms
一项评价KarXT治疗阿尔茨海默病相关的精神行为症状的安全性和有效性的随机、双盲、安慰剂对照、平行组III期研究(ADEPT-2)
[Translation] A randomized, double-blind, placebo-controlled, parallel-group phase III study to evaluate the safety and efficacy of KarXT in the treatment of psychiatric and behavioral symptoms associated with Alzheimer's disease (ADEPT-2)
主要目的: ● 根据神经精神量表-临床医生等级评定量表(NPI-C):幻觉和妄想(H+D)评分,评价KarXT相较于安慰剂治疗AD相关的精神行为症状受试者的有效性 关键次要目的: ● 根据Cohen-Mansfield激越量表(CMAI)评分,评估KarXT相较于安慰剂治疗AD相关的精神行为症状受试者激越的有效性 其他次要目的: ● 使用下述指标评价KarXT相较于安慰剂的有效性: - 使用临床总体印象-严重程度(CGI-S)量表评估疾病的总体严重程度。CGI-S要求评估者在对严重程度进行总体评估之前考虑精神病(幻觉和妄想)的各个方面 - NPI-C核心评分:幻觉、妄想、激越和攻击维度,NPI-C:激越评分 NPI-C核心评分:照料者困扰量表(幻觉、妄想、激越和攻击维度)- 有效率(判断为有效者的定义为NPI-C: H+D[幻觉和妄想]评分改善≥40%) 安全性目的: ● 评价KarXT相较于安慰剂在AD相关的精神行为症状受试者中的安全性和耐受性
[Translation] Primary objective: ● To evaluate the effectiveness of KarXT compared with placebo in treating subjects with AD-related psychiatric and behavioral symptoms based on the Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C): Hallucinations and Delusions (H+D) scores Key secondary objectives: ● To evaluate the effectiveness of KarXT compared with placebo in treating agitation in subjects with AD-related psychiatric and behavioral symptoms based on the Cohen-Mansfield Agitation Inventory (CMAI) scores Other secondary objectives: ● To evaluate the effectiveness of KarXT compared with placebo using the following indicators: - The overall severity of the disease was assessed using the Clinical Global Impression-Severity (CGI-S) scale. CGI-S requires assessors to consider various aspects of psychosis (hallucinations and delusions) before making an overall assessment of severity - NPI-C Core Score: Hallucinations, Delusions, Agitation, and Aggression Dimensions, NPI-C: Agitation Score NPI-C Core Score: Caregiver Distress Scale (Hallucinations, Delusions, Agitation, and Aggression Dimensions) - Responsiveness (responders were defined as those with an improvement of ≥40% in NPI-C: H+D [hallucinations and delusions] scores) Safety Objectives: ● To evaluate the safety and tolerability of KarXT compared to placebo in subjects with psychiatric and behavioral symptoms associated with AD
一项在不适合使用组织型纤溶酶原激活剂或进行血栓切除术的急性缺血性卒中成人受试者中研究 redasemtide (S-005151) 相较于安慰剂的疗效和安全性的 IIb 期、多国、随机、双盲研究
[Translation] A Phase IIb, multinational, randomized, double-blind study investigating the efficacy and safety of redasemtide (S-005151) versus placebo in adult subjects with acute ischemic stroke who are not candidates for tissue plasminogen activator or thrombectomy
比较 redasemtide 与安慰剂的疗效 评价 redasemtide 的安全性和耐受性
[Translation] Compare the efficacy of redasemtide with placebo Assess the safety and tolerability of redasemtide
100 Clinical Results associated with PPD Pharmaceutical Development(Beijing)Co., Ltd.
0 Patents (Medical) associated with PPD Pharmaceutical Development(Beijing)Co., Ltd.
100 Deals associated with PPD Pharmaceutical Development(Beijing)Co., Ltd.
100 Translational Medicine associated with PPD Pharmaceutical Development(Beijing)Co., Ltd.