上海Baxdrostat片III期临床试验-一项在成人原发性醛固酮增多症受试者中评估Baxdrostat的有效性和安全性的研究

登记号	CTR20253544	试验状态	进行中
申请人联系人	车诗静	首次公示信息日期	2025-09-03
申请人名称	AstraZeneca AB/ 阿斯利康全球研发（中国）有限公司/ Patheon Pharmaceuticals, Inc.

登记号	CTR20253544
相关登记号	暂无
药物名称	Baxdrostat片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	原发性醛固酮增多症
试验专业题目	一项在成人原发性醛固酮增多症受试者中评估Baxdrostat的有效性和安全性的随机、双盲、安慰剂对照、平行组研究
试验通俗题目	一项在成人原发性醛固酮增多症受试者中评估Baxdrostat的有效性和安全性的研究
试验方案编号	D6974C00001	方案最新版本号	1.0
版本日期:	2025-04-07	方案是否为联合用药	否

申请人名称	[["AstraZeneca AB"],["阿斯利康全球研发（中国）有限公司"],["Patheon Pharmaceuticals, Inc."]]
联系人姓名	车诗静	联系人座机	021-61308402	联系人手机号
联系人Email	Clinical-Trial-Disclosure-Mailbox@astrazeneca.com	联系人邮政地址	上海市-上海市-静安区西藏北路88号16	联系人邮编	200040

评价baxdrostat与安慰剂相比在原发性醛固酮增多症受试者中的有效性和安全性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["签署知情同意时年龄≥ 18岁，男女不限。"],["有原发性醛固酮增多症诊断记录"],["对于筛选时使用MRA或保钾利尿剂的受试者，愿意且能够根据研究要求停止MRA或保钾利尿剂用药。"],["根据中心实验室，筛选时eGFR ≥ 45 mL/min/1.73 m2"],["根据中心实验室，筛选时血清钾水平≥ 3.0且< 5.0 mmol/L。"],["随机前接受稳定的降压药物治疗方案至少4周。"],["随机时AOBPM平均坐位SBP ≥ 135 mmHg。"]]
排除标准	[["如果筛选时未使用MRA或保钾利尿剂：平均坐位SBP > 180 mmHg或平均坐位DBP ≥ 110 mmHg（AOBPM）。 如果筛选时使用MRA或保钾利尿剂：平均坐位SBP > 160 mmHg或平均坐位DBP ≥ 100 mmHg。"],["既往因肾上腺腺瘤接受手术治疗或计划在研究过程中接受肾上腺切除术、去肾交感神经术或肾上腺消融术。"],["存在以下已知的继发HTN原因：肾动脉狭窄、未控制或未治疗的甲状腺功能亢进症、未控制或未治疗的甲状腺功能减退症、嗜铬细胞瘤、库欣综合征、主动脉缩窄。"],["筛选时中心实验室测定的血清钠水平< 135 mmol/L。"],["筛选时纽约心脏病协会心功能分级为IV级。"],["持续性房颤。"],["随机前2周内接受任何MRA或保钾利尿剂治疗。"]]

试验药	[["中文通用名:NA 英文通用名:Baxdrostat 商品名称:NA","剂型:片剂 规格:1mg/片 用法用量:口服，每日2片 用药时程:52周"],["中文通用名:NA 英文通用名:Baxdrostat 商品名称:NA","剂型:片剂 规格:2mg/片 用法用量:口服，每日2片 用药时程:52周"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:片剂 规格:NA 用法用量:口服，每日2片 用药时程:52周"]] 序号 名称 用法

主要终点指标及评价时间	[["第8周时坐位SBP相对于基线的变化","第8周","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["第52周时坐位SBP相对于RWD基线（第44周）的变化","第52周","有效性指标"],["第52周时PRA相对于RWD基线（第44周）的变化百分比","第52周","有效性指标"],["基线时血清钾< 3.7 mmol/L或接受补钾治疗的受试者在第8周时未接受补钾治疗的情况下达到血清钾≥ 3.7 mmol/L的比例","第8周","有效性指标"],["第8周时PRA相对于基线的变化百分比","第8周","有效性指标"],["基线时24小时尿醛固酮≥ 10 μg的受试者在第8周时达到24小时尿醛固酮< 10 μg的比例","第8周","有效性指标"],["第8周时24小时尿白蛋白相对于基线的变化","第8周","有效性指标"],["AE、SAE、死亡、导致IMP停用的AE和AESI（高钾血症和低钠血症）","直到第54周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王卫庆	学位	医学博士	职称	主任医师
	电话	13817836184	Email	wqingw@hotmail.com	邮政地址	上海市-上海市-黄浦区瑞金二路197号
	邮编	200025	单位名称	上海交通大学医学院附属瑞金医院

[["上海交通大学医学院附属瑞金医院","王卫庆","中国","上海市","上海市"],["上海交通大学医学院附属瑞金医院","王继光","中国","上海市","上海市"],["北京大学第一医院","高莹","中国","北京市","北京市"],["北京大学第三医院","唐熠达/李卫虹","中国","北京市","北京市"],["南京鼓楼医院","毕艳","中国","江苏省","南京市"],["中南大学湘雅二医院","刘玲","中国","湖南省","长沙市"],["武汉大学人民医院","蒋学俊","中国","湖北省","武汉市"],["四川大学华西医院","陈涛","中国","四川省","成都市"],["北京大学人民医院","刘靖","中国","北京市","北京市"],["华中科技大学同济医学院附属同济医院","杨雁","中国","湖北省","武汉市"],["延安大学咸阳医院","廉秋芳","中国","陕西省","咸阳市"],["天津医科大学总医院","刘铭","中国","天津市","天津市"],["重庆医科大学附属第一医院","李启富","中国","重庆市","重庆市"],["Royal Perth Hospital","Markus Schlaich","澳大利亚","WA","Perth"],["Hudson Institute of Medical Research","Jun Yang","澳大利亚","VIC","Clayton"],["Princess Alexandra Hospital","Michael Stowasser","澳大利亚","QLD","Brisbane"],["Alberta Health Services","Alexander Leung","加拿大","Alberta","Calgary"],["The Ottawa Hospital","Gregory Hundemer","加拿大","Ontario","Ottawa"],["HSCM","Remi Goupil","加拿大","QC","Montreal"],["Sunnybrook Health Sciences Centre","Ayodele Odutayo","加拿大","ON","Toronto"],["Hopital Europeen Georges Pompidou","Laurence Amar","法国","PARIS Cedex 15","PARIS Cedex 15"],["CHU de Bordeaux","Julien Doublet","法国","Bordeaux","Bordeaux"],["Hopital de Bois Guillaume - CHU ROUEN","Antoine-Guy Lopez","法国","Bois","Guillaume"],["Hopital Bichat - Claude-Bernard","Emmanuelle Vidal-Petiot","法国","PARIS","PARIS"],["Hopital de la Timone","Gabrielle Sarlon","法国","Marseille CEDEX 5","Marseille CEDEX 5"],["HOPITAL CLAUDE HURIEZ","Stephanie Espiard","法国","Lille","Lille"],["Centre Hospitalier Universitaire Amiens Picardie","Abdallah Al Salameh","法国","Amiens","Amiens"],["Charite-Universitatsmedizin Berlin","Markus van der Giet","德国","Berlin","Berlin"],["Kardiopraxis Schirmer","Stephan Schirmer","德国","Kaiserslautern","Kaiserslautern"],["Universitaetsklinikum Carl Gustav Carus TU Dresden","Stefan Bornstein","德国","Dresden","Dresden"],["Universitatsklinikum Düsseldorf","Johannes Stegbauer","德国","Dusseldorf","Dusseldorf"],["LMU Klinikum der Universitat München","Nicole Reisch","德国","Munchen","Munchen"],["Universitatsklinikum Würzburg","Carmina Teresa Fu？","德国","Wurzburg","Wurzburg"],["Praxis Reinfeld-Mitte","Joachim Weimer","德国","Reinfeld (Holstein)","Reinfeld (Holstein)"],["Postgraduate Institute of Medical Education & Research","Sanjay Bhadada","印度","Chandigarh","Chandigarh"],["All India Institute of Medical Sciences","Rajesh Khadgawat","印度","New Delhi","Delhi"],["Seth GS Medical College & KEM Hospital","Tushar Bandgar","印度","Maharashtra","Mumbai"],["K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre","Manjunath Goroshi","印度","Karnataka","Belagavi"],["T. N. Medical College & BYL Nair Charitable Hospital","Nikhil Bhagwat","印度","Maharashtra","Mumbai"],["Osmania General Hospital","Rakesh Sahay","印度","Andhra Pradesh","Hyderabad"],["Institute of Post Graduate Medical Education & Research","Pranab Kumar Sahana","印度","West Bengal","Kolkata"],["Christian Medical College","Hesarghatta a Asha","印度","Tamilnadu","Vellore"],["A.O.U. Citta della Salute e della Scienza di Torino","Franco Veglio","意大利","Piemonte","Torino"],["Istituto Auxologico Italiano","Grzegorz Bilo","意大利","MI","Milano"],["ASST degli Spedali Civili di Brescia (Presidio Spedali Civil","Maria Muiesan","意大利","Brescia","Brescia"],["AZIENDA OSPEDALIERA POLICLINICO S. ORSOLA - MALPIGHI","Guido Di Dalmazi","意大利","BO","Bologna"],["Azienda Ospedaliero Universitaria Careggi Largo","Canu Letizia","意大利","FI","Firenze"],["ASST Grande Ospedale Metropolitano Niguarda","Alessandro Maloberti","意大利","Milano","Milano"],["Oita University Hospital","Yuichi Yoshida","日本","Oita","Yufushi"],["Social Welfare Organization Gift Foundation Saiseikai, Yokohamashi Tobu Hospital","Ichijo Takamasa","日本","Kanagawa","Yokohamashi"],["Showa General Hospital","Katsutoshi Takahashi","日本","Tokyo","Shinjukuku"],["St. Marianna University Hospital","Masakatsu Sone","日本","KanagawaKen","Kawasakishi"],["Tokyo Women's Medical University Hospital","Atsuhiro Ichihara","日本","Tokyo","Shinjukuku"],["International University of Health and Welfare Mita Hospital","Mitsuhiro Nishimoto","日本","Tokyo","Minatoku"],["Toho University Omori Medical Center","Hiroshi Uchino","日本","Tokyo","Otaku"],["Hospital Universitario Ramon y Cajal","Marta Araujo Castro","西班牙","Comunidad de Madrid","Madrid"],["Hospital Clinic Barcelona","Felicia Hanzu","西班牙","Cataluna","Barcelona"],["Hospital Universitario Fundacion Jimenez Diaz","Jorge Ruiz Sanchez","西班牙","Comunidad de Madrid","Madrid"],["Hospital Clinico Universitario San Carlos","Mario Pazos Guerra","西班牙","Comunidad de Madrid","Madrid"],["Hospital Universitario La Paz","Paola Parra Ramirez","西班牙","Comunidad de Madrid","Madrid"],["Hospital Universitario Virgen del Rocio","Miguel angel Mangas Cruz","西班牙","Andalucia","Sevilla"],["National Taiwan University Hospital","Vin-Cent Wu","中国台湾","Taipei","Taipei"],["Veterans General Hospital Taichung","Jun-Sing Wang","中国台湾","Taichung","Taichung"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Shang-Jyh Hwang","中国台湾","Kaohsiung","Kaohsiung"],["National Taiwan University Hospital Hsin-Chu Branch","Chieh-Kai Chan","中国台湾","Zhubei","Zhubei"],["National Taiwan University Hospital Yunlin Branch","Chen Zheng-Wei","中国台湾","Yunlin","Yunlin"],["Chang Gung Medical Foundation Linkou Branch","Feng-Hsuan Liu","中国台湾","Taoyuan","Taoyuan"],["Addenbrooke's Hospital","Mark Gurnell","英国","Cambridge","Cambridge"],["St Bartholomew’s Hospital","William Drake","英国","London","London"],["Guys And St Thomas Hospital","Russell Senanayake","英国","London","London"],["University Hospital of Wales","Aled Rees","英国","CARDIFF","CARDIFF"],["Ninewells Hospital & Medical School","Isla Mackenzie","英国","Dundee","Dundee"],["Southern Illinois University School of Medicine - Hypertension Clinic","John Flack","美国","Springfield","Springfield"],["Headlands Research","Christopher Romero","美国","Brownsville","Brownsville"],["Brigham and Women's Hospital","Anand Vaidya","美国","Boston","Boston"],["Northwestern University Feinberg School of Medicine","Wenyu Huang","美国","Chicago","Chicago"],["UCSF San Francisco General Hospital","Ramin Sam","美国","San Francisco","San Francisco"],["Weill Cornell Medical College","Crystal Kamilaris","美国","New York","New York"],["University of Michigan","Adina Turcu","美国","Ann Arbor","Ann Arbor"],["Olive Branch Family Medical Center","Randall Huling","美国","Olive Branch","Olive Branch"],["Clay Platte Family Medicine","Scott Kuennen","美国","Kansas City","Kansas City"],["University of Texas Southwest","Oksana Hamidi","美国","Dallas","Dallas"],["Cleveland Clinic","Pratibha Rao","美国","Cleveland","Cleveland"],["Ohio State University Wexner Medical Center","Aysegul Eren","美国","Columbus","Columbus"],["Tufts Medical Center","Feyza Erenler","美国","Boston","Boston"],["Mayo Clinic - Rochester","Irina Bancos","美国","Rochester","Rochester"],["Cedars - Sinai Medical Center","Anat Ben-Shlomo","美国","Los Angeles","Los Angeles"],["Johns Hopkins University","Amir Hamrahian","美国","Baltimore","Baltimore"],["OHSU Knight Cancer Institute","Nupur Mistry","美国","Portland","Portland"],["University of Connecticut Health Center","Tarunya Vedere","美国","Farmington","Farmington"],["UC Davis Medical Center","Sonal Phatak","美国","Sacramento","Sacramento"],["Columbia Nephrology Associates PA","Asha Bailey","美国","Columbia","Columbia"],["University of Pennsylvania","Debbie Cohen","美国","Philadelphia","Philadelphia"],["Northeast Clinical Research Center Inc","Nelson Kopyt","美国","Bethlehem","Bethlehem"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海交通大学医学院附属瑞金医院临床试验伦理委员会","同意","2025-08-13"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 25 ； 国际: 180 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；