噻托溴铵粉吸入剂 ｜已完成

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基本信息

数据来源:临床试验登记与信息公示平台，查看原文请点击
登记号
CTR20132617
相关登记号
曾用名
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
慢性阻塞性肺病
试验通俗题目
慢性阻塞性肺病患者激素撤退试验
试验专业题目
评价逐步停用吸入型皮质类固醇激素对接受支气管扩张优化疗法的重度极重度COPD患者影响
试验方案编号
352.2046
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示

申请人信息

申请人名称
联系人姓名
勃林格殷格翰 临床试验信息公示组
联系人座机
+862152883966
联系人手机号
联系人Email
MEDCTIDgroup.CN@boehringer-ingelheim.com
联系人邮政地址
上海市静安区南京西路1601号越洋广场29楼
联系人邮编
200040

临床试验信息

试验分类
安全性和有效性
试验分期
IV期
试验目的
澄清接受优化疗法（根据指导原则）的重度极重度COPD患者持续使用iCS的必要性，考察iCS逐步撤退对这部分患者的影响。了解患者人群的特征，分析患者表型和基因型，鉴定亚组人群和激素适用标志物。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
40岁(最小年龄)至 无限制岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
  • 男性或女性患者，年龄≥40岁
  • 符合GOLD诊断的重度或极重度COPD的定义
  • 患者目前吸烟或以前曾经吸烟，且吸烟史≥10包年
  • 在最初的筛选访视（访视1）前的12个月内，患者必须至少发生过一次COPD疾病加重
排除标准
  • 患有COPD以外的其他重大疾病。严重的酒精和药物滥用史者
  • 当前临床诊断为哮喘，经医生判断需要接受吸入型或口服糖皮质激素治疗的患者
  • 曾进行肺切除胸廓造口术的患者
  • 规律日间吸氧
  • 近期（3个月内）发生过心肌梗塞
  • 近期（ 6周内）发生呼吸道感染或COPD加重的患者
  • 近期（6周内）使用过全身性糖皮质激素且用药剂量超过5mg/天者
  • 近期（3个月内）发生过不稳定型或危及生命的心律失常，患者需要干预治疗或改变治疗药物
  • 近期（1年内）曾因心力衰竭而住院的患者
  • 当前正在接受放射治疗和化学治疗的恶性肿瘤患者
  • 临床诊断为支气管扩张的患者
  • 孕妇或哺乳期的妇女
  • 已知对试验药物过敏
  • 目前或最近（ 30天内）参加过其他临床试验
  • 目前或最近( 4周内）完成肺康复项目

试验分组

试验药
名称 用法
中文通用名:噻托溴铵吸入胶囊(思力华)
用法用量:剂型：粉末剂 规格：18μg 给药方式：采HandiHaler吸入器经口吸入。 用药频次：每日1次，每次1喷。 剂量：每日18μg
中文通用名:昔萘酸沙美特罗气雾剂 (施立稳)
用法用量:剂型：氢氟烷（HFA134a）定量吸入器。 规格：每喷25μg 给药方式：经口吸入 剂量：100μg（每日2次，每次2喷，每喷25μg）。
中文通用名:丙酸氟替卡松
用法用量:剂型：氢氟烷（HFA134a）定量吸入器。 规格：每喷250μg 给药途径：经由定量吸入器经口吸入 用药频次：每天2次，每次2喷 剂量：1000μg（每日2次，每次2喷，每喷250μg）。
对照药
名称 用法
中文通用名:噻托溴铵吸入胶囊(思力华)
用法用量:剂型：粉末剂 规格：18μg 给药方式：采HandiHaler吸入器经口吸入。 用药频次：每日1次，每次1喷。 剂量：每日18μg
中文通用名:昔萘酸沙美特罗气雾剂 (施立稳)
用法用量:剂型：氢氟烷（HFA134a）定量吸入器。 规格：每喷25μg 给药方式：经口吸入 剂量：100μg（每日2次，每次2喷，每喷25μg）。
中文通用名:丙酸氟替卡松
用法用量:剂型：氢氟烷（HFA134a）定量吸入器。 规格：每喷250μg/125μg/50μg/安慰剂。 给药途径：经由定量吸入器经口吸入。 用药频次：每天2次，每次2喷。 剂量：1000μg/500μg/200μg/安慰剂（每日2次, 每次2喷）

终点指标

主要终点指标
指标 评价时间 终点指标选择
本试验的主要终点是在随机治疗阶段中，首次出现中重度COPD加重的时间 48周 有效性指标
次要终点指标
指标 评价时间 终点指标选择
COPD中重度加重的例数 48周 有效性指标
COPD加重的严重程度 48周 有效性指标
COPD加重而住院的例数 48周 有效性指标
肺功能的改变 48周 有效性指标
呼吸困难的改变 48周 有效性指标
运动耐量的改变 48周 有效性指标
健康相关的生活质量的改变 48周 有效性指标
炎性介质标志物的改变 48周 有效性指标
痰液微生物学的改变 48周 有效性指标
数据安全监察委员会（DMC）
无
为受试者购买试验伤害保险
有

研究者信息

姓名 学位 职称 电话 Email 邮政地址 邮编 单位名称
钟南山 教授，院士 020-83062208 nanshan@vip.163.com 广州市沿江西路151号 510120 广州医学院第一附属医院

各参加机构信息

机构名称 （主要）研究者 国家 地区 城市
广州医学院第一附属医院 钟南山 中国 广东 广州
北京医科大学第三医院 姚婉贞 中国 北京 北京
首都医科大学附属北京朝阳医院 林英翔 中国 北京 北京
复旦大学中山医院 白春学 中国 上海 上海
上海肺科医院 李惠萍 中国 上海 上海
北京协和医院 蔡柏蔷 中国 北京 北京
华中科技大学同济医学附属协和医院 辛建保 中国 湖北 武汉
重庆医科大学附属第一医院 吴亚梅 中国 重庆 重庆
广州医学院第一附属医院 汤彦 中国 广东 广州
Westmead Hospital John Wheatley Australia NSW Westmead
The Burnside War Memorial Hospital Michael Chia Australia SA Toorak Gardens
Repatriation General Hospital Dimitar Sajkov Australia SA Daw Park
The Queen Elizabeth Hospital Jonathan Polasek Australia SA Woodville
Concord Repatriation General Hospital Matthew Peters Australia NSW Concord
P3 Research Dean Quinn New Zealand N/A Newtown Wellington NZ
P3 Research Eunice Kelly New Zealand N/A Tauranga
Christchurch Hospital Michael Epton New Zealand N/A Christchurch
Dunedin Hospital Benedict Brockway New Zealand N/A Dunedin
Middlemore Hospital Stuart Jones New Zealand N/A Otahuhu New Zealand
Waikato Hospital Graham Mills New Zealand N/A Hamilton
University of Auckland Tanya McWilliams New Zealand N/A Auckland NZ
U.Z. Gasthuisberg Marc Decramer Belgium N/A Leuven
CHU St. Pierre Vincent Ninane Belgium N/A Bruxelles
A.Z. Middelheim Lieven Bedert Belgium N/A Middelheim
Clinique et maternite Sainte-Elisabeth Jean-Benoit Martinot Belgium N/A Namur
Prive Praktijk Luc Van Zandweghe Belgium N/A Lebbeke
CHU de Charleroi - Hopital Andre Vesale Rudi Peche Belgium N/A Montigny-le-Tilleul
AZ Turnhout Peter Driesen Belgium N/A Turnhout
AZ St.-Elisabeth Yves Mentens Belgium N/A Herentals
Hospital St Nicolas Bernard Plas Belgium N/A Eupen
Clinique Parc Leopold Alfred Flemale Belgium N/A Bruxelles
Hospital Saint Joseph Pierre Fievez Belgium N/A Gilly
Hospital Saeo Lucas da PUC do Rio Grande do Sul Carlos Fritscher Brazil RS Porto Alegre
Hospital Geral de Goiania Heicilainy Gondim Brazil GO Goiania
Lar Escola Saeo Francisco Jose Roberto Brito Jardim Brazil SP Sao Paulo
Hospital das Clinicas da Universidade Federal de Goias Maria Auxiliadora Carmo Moreira Brazil GO Goiania
Irmandade Santa Casa de Misericordia de Porto Alegre Rubin Adalberto Brazil RS Porto Alegre
Tri-service General Hospital Wann-Cherng Perng 中国 N/A Taipei
National Taiwan University Hospital Ping-Hung Kuo 中国 N/A Taipei
Cheng Ching General Hospital-Chung Kang Branch Ren-Guang Wu 中国 N/A Taichung
Kaohsiung Medical University Chung-Ho Memorial Hospital Ming-Shyan Huang 中国 N/A Kaohsiung
Chung Shan Medical University Hospital Chang-Yao Tsao 中国 N/A Taiwan
China Medical University Hospital Liang-Wen Hang 中国 N/A Taiwan
MCU-Filemon Dionisio Tanchoco Medical Foundation Lalaine Mortera Philippines N/A Caloocan
Philippine General Hospital Camilo Roa Philippines N/A Manila
Manila Doctors Hospital Aileen Wang Philippines N/A Manila
Philippine Heart Center Teresita De Guia Philippines N/A Quezon
National Kidney & Transplant Institute Manuel Jorge Philippines N/A Quezon
FEU-NRMF Medical Center Val Custodio Philippines N/A Quezon
Quirino Memorial Medical Center Joel Santiaguel Philippines N/A Quezon
Asian Hospital & Medical Center Lenora Fernandez Philippines N/A Muntinlupa
Aarhus Sygehus Ronald Dahl Denmark N/A Aarhus C
Odense Universitetshospital Ingrid Titlestad Denmark N/A Odense C
Bispebjerg Hospital Vibeke Backer Denmark N/A Kobenhavn NV
Pneumologisches Forschungsinstitut GmbH Helgo Magnussen Germany N/A Grosshansdorf
Klinik Donaustauf Michael Pfeifer Germany N/A Donaustauf
Universitatsklinikum Koeln Andrea Koch Germany N/A Koeln
Universitatsklinikum Mainz Stephanie Korn Germany N/A Mainz
Universitatsklinikum Gieben und Marburg Claus Vogelmeier Germany D Marburg
Universitatsklinikum Heidelberg Felix Herth Germany N/A Heidelberg
Klinik fur Pneumologie, Allergologie und Schlafmedizin Juliane Kronsbein Germany N/A Bochum
Klinische Forschung Berlin Mitte Ruth Knorr Germany N/A Berlin
IKF Pneumologie GmbH & Co.KG Andreas Eich Germany N/A Frankfurt
Lungenfachklinik Immenhausen Stefan Andreas Germany N/A Immenhausen
Medizinische Klinik und Poliklinik I Claus Neurohr Germany N/A Munchen
Klinik fur Allgemeine Innere Medizin Burkhard Bewig Germany N/A Kiel
MECS GmbH Frank Kaessner Germany N/A Cottbus
Atemwegszentrum Neukolln Rainer Gebhardt Germany N/A Berlin
MECS Mommsenstr. 2 a GmbH Ralf Schultebraucks Germany N/A Berlin
Facharztzentrum am Krankenhaus Winfried Schroeder-Babo Germany N/A Gelnhausen
Lungenpraxis am Maingau Peter Kardos Germany N/A Frankfurt/Main
Pneumologisches Forschungsinstitut GmbH Petra Mikloweit Germany N/A Geesthacht
Praxis Dr. Keller Claus Keller Germany N/A Frankfurt
Hospital del Mar Antonio Ferrer Spain N/A Barcelona
Hospital de Cruces Juan Bautista Galdiz Iturri Spain Spain Barakaldo (Bilbao)
Hospital Clinic i Provincial de Barcelona Roberto Rodriguez - Roisin Spain Spain Barcelona
Hospital Son Espases (Antes Son Dureta) Alberto Alonso Spain Spain Palma de Mallorca
Complejo Hospitalario Infanta Cristina Jose Antonio Gutierrez Lara Spain Spain Badajoz
Ciutat Sanitaria Universitaria de Bellvitge Eva Farrero Spain Spain Hospitalet de Llobregat
Clinica Quiron Madrid Jose Maria Echave Sustaeta Spain N/A Pozuelo de Alarcon
Hospital Universitario Virgen del Rocio Pilar Cejudo Spain Spain Sevilla
Hospital Santa Catarina Juan Roldan Spain N/A Salt
Hospital Nord Pascal Chanez France N/A Marseille
CH Sud Reunion Fabrice Paganin France N/A Saint-Pierre
CH Sud Reunion Claude Arvin-Berod France N/A Saint-Pierre
Groupe Hospitalier Sud Reunion Eric Huchot France N/A Saint Pierre
Hospital sud de la Reunion Vincent Boulay France N/A Saint Pierre la Reunion
Centre Hospitalier Sainte Barbe - Unisante Martine Claussner Paulignan France N/A Forbach
Hospital de la Cavale Blanche Christophe Gut Gobert France N/A Brest
Hospital de la Cavale Blanche Christophe Leroyer France N/A Brest
Hospital de la Cavale Blanche Francis Couturaud France N/A Brest
Clinique du Parc Philippe Tarodo de la Fuente France N/A Castelnau le Lez
Clinique du Parc Christophe Brousse France N/A Castelnau le Lez
Clinique du Parc Olivier Ortega France N/A Castelnau le Lez
Cabinet Medical Jacques Dupouy France N/A Nimes
Hospital Laennec Antoine Magnan France N/A Nantes
Hospital Laennec Patrick Germaud France N/A Nantes
Hospital Laennec Arnaud Cavailles France N/A Nantes
Hospital Arnaud de Villeneuve Lahouari Meziane France N/A Montpellier
Hospital Arnaud de Villeneuve Xavier Quantin France N/A Montpellier
Institut Arnault Tzanck Olivier Castelnau France F Saint Laurent du Var
Institut Arnault Tzanck Guy Rene Boyer France F Saint Laurent du Var
Cabinet Medical Serge Verdier France N/A Perpignan
Cabinet Medical Michel Hernandez France N/A Perpignan
Cabinet Medical Monique Verdier France N/A Perpignan
Hospital Caremeau Charles Le Merre France N/A Nimes
Hospital Caremeau Alain Proust France N/A Nimes
Hospital Caremeau Patrice Ray France N/A Nimes
Hospital Europeen Marseille Herve Pegliasco France F Marseille
Centre Medical Erdre Saint Augustin Jean-Yves Jasnot France N/A Nantes
Hospital Gabriel Montpied Denis Caillaud France N/A Clermont Ferrand
Hospital Larrey Roger Escamilla France F Toulouse
Hospital Larrey Danielle Brouquieres France F Toulouse
Hospital Larrey Marie-Christine Pujazon France F Toulouse
Clinique Pasteur Christophe Raspaud France N/A Toulouse
Hospital Abderrahmen Mami Abdelattif Chabbou Tunisia N/A Ariana
Hospital Abderrahmen Mami Mohamed Lamine Megdiche Tunisia N/A Ariana
Hospital Charles Nicolle Hend Bouacha Tunisia N/A Tunis
CHU Farhet Hached Mohamed Benzarti Tunisia N/A Sousse
CHU Hedi Chaker Abdelkader Ayoub Tunisia N/A Sfax
General Hospital of Thessaloniki Lazaros Sichletides Greece N/A Thessaloniki
General Hospital of Thessaloniki Marianna Kakoura Greece N/A Thessaloniki
Athens Hospital of Chest Diseases Panagiotis Demertzis Greece N/A Athens
Athens Hospital of Chest Diseases Nikolaos Koulouris Greece N/A Athens
Sotiria General Hospital of Chest Diseases of Athens Michail Toubis Greece N/A Athens
University Hospital of Heraklion Nicolaos Siafakas Greece N/A Heraklion
Attikon, Panepistimiako Geniko Nosokomeio Spyros Papiris Greece N/A Athens
Evangelismos Hospital Theodoros Vassilakopoulos Greece N/A Athens
University Hospital of Larisa Konstantinos Gourgoulianis Greece N/A Larisa
Athens Hospital of Chest Diseases Mina Gaga Greece N/A Athens
General Hospital of Athens Georgios Tatsis Greece N/A Athens
Ospedale di Cisanello Pier Luigi Paggiaro Italy N/A Pisa
Azienda Ospedaliera Universitaria Giuseppe Ugo Di Maria Italy IT Catania
Ospedale Policlinico Leonardo M. Fabbri Italy N/A Modena
Azienda Ospedaliera Antonio Foresi Italy N/A Sesto San Giovanni (MI)
Ospedale D'Avanzo Maria Pia Foschino Italy N/A Foggia
Fondazione Salvatore Maugeri Claudio Fracchia Italy N/A Montescano (PV)
A.O.U. Arcispedale S.Anna Alberto Papi Italy IT Cona (FE)
Fondazione Salvatore Maugeri Antonio Spanevello Italy N/A Tradate (VA)
Medisch Centrum Leeuwarden H.R. Pasma Netherlands N/A Leeuwarden
Maxima Medisch Centrum D.R.A.J. De Munck Netherlands N/A Veldhoven
Sint Franciscus Gasthuis A. Rudolphus Netherlands N/A Rotterdam
Atrium Medisch Centrum J.A. Noord van Netherlands N/A Heerlen
Regional Hospital for Pulmonary Diseases Hristo Metev Bulgaria N/A Rousse
Multiprofile Hospital for Active Treatment Vania Illieva-Fartunova Bulgaria N/A Stara Zagora
Specialized Hospital for Active Treatment Dencho Osmanliev Bulgaria N/A Sofia
Multiprofile Hospital for Active Treatment Evelina Troshanova Bulgaria N/A Bourgas
Military Medical Academy Kosta Kostov Bulgaria N/A Sofia
Sofia District Dispensary for Pulmonary Diseases Kiril Rashkov Palaveev Bulgaria N/A Sofia
Medical Centre for Pneumo-Phthisiatric Diseases Ana Dancheva Bulgaria N/A Sofia
Multiprofile District Hospital for Active Treatment Margarita Taseva Bulgaria N/A Veliko Tarnovo
Pulmonology of Szarvas Ltd. Maria Jedlinszki Hungary N/A Szarvas
Institute of Chest Diseases of Csongrad County Municipality Beatrix Balint Hungary N/A Szeged
Toldy Ferenc Hospital and Out-patient Care Unit Katalin Rajkay Hungary N/A Cegled
Selye Janos Hospital Judit Schlezak Hungary N/A Komarom
Men for Care Kft. - Szazhalom Health Center Eva Radeczky Hungary N/A Szazhalombatta
Infer-Med Ltd. Marta Papp Hungary N/A Pecs
Gyogysziget, Private Praxis Imre Meszaros Hungary N/A Szigetszentmiklos
University School of Medical Sciences Halina Batura-Gabryel Poland N/A Poznan
NZOZ ALERGO-MED Danuta Madra-Rogacka Poland N/A Poznan
Lung Diseases Outpatient Clinic Beata Asankowicz-Bargiel Poland N/A Ostrow Wielkopolska
Instytut Gruzlicy i Ch. Pluc Stefan Wesolowski Poland N/A Warsaw
Wojewodzki Hospital Gabriela Mieszko Filipczyk Poland N/A Bytom
Dolnoslaskie Center of Lung Diseases Michal Silber Poland N/A Warsaw
Specialistyczny Zespol Gruzlicy i Chorob Pluc Malgorzata Pawlukiewicz Poland N/A Rzeszow
Non-public Health Care Unit ALLMED S.C. Aleksandra Chwist-Nowak Poland N/A Piekary Slaskie
GOU VPO St. Petersburg State Medical University Mikhail Ilkovich Russia N/A St. Petersburg
Medical University of Roszdrav Alexander Zhestkov Russia N/A Samara
Saratov State Medical University of Roszdrav Natalia Astafyeva Russia N/A Saratov
MUZ Clinical Hospital Alexander Khokhlov Russia N/A Yaroslavl
Municipal Institution of Healthcare Nataliya Shilkina Russia N/A Yaroslavl
Medical Academy of Roszdrav Irina Mishina Russia N/A Ivanovo
President's Medical Center Elena Alekseeva Russia N/A Moscow
Federal State Institution Lubov Nikishenkova Russia N/A Moscow
OOO Medical Union New Clinic Igor Leshchenko Russia N/A Ekaterinburg
Ukrainian State Scientific Research Inst. of Invalid Rehab., Sergiy Shevchuk Ukraine N/A Vinnytsya
L.T. Malaya Institute of Therapy AMS of Ukraine Lubov Voeykova Ukraine N/A Kharkiv
City Clinical Hospital No. 17 Sergiy Krasnokutskiy Ukraine N/A Kharkov
Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky Liudmyla Iashyna Ukraine N/A Kiev
State Medical University of Vinnitsa 'Pirogov' Yuriy Mostovoiy Ukraine N/A Vinnitsa
Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky Oleksandr Dziublyk Ukraine N/A Kiev
Regional centre of Phtysiology and Pulmonology Mykola Ostrovskyy Ukraine N/A Ivano-Frankivsk
Mersin Universitesi Tip Fakultesi Sibel Atis Turkey N/A Mersin
19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D Levent Erkan Turkey N/A Samsun
Marmara Universitesi Tip Fakultesi Sait Karakurt Turkey N/A Istanbul
Yedikule Gogus Hastaliklari Hastanesi Sedat Altin Turkey N/A Istanbul
Kocaeli Universitesi Tip Fakultesi Ahmet Ilgazli Turkey N/A Izmit
Dr. Lutfi Kirdar Kartal Egitim ve Arastirma Hastanesi Benan Caglayan Turkey N/A Istanbul
Erciyes Universitesi Tip Fakultesi Inci Gulmez Turkey N/A Kayseri
Yedikule Gogus Hastaliklari Hastanesi Erdogan Cetinkaya Turkey N/A Istanbul
Ataturk Gogus Has. ve Gogus Cerrahisi Pinar Ergun Turkey N/A Ankara
Pamukkale Universitesi Tip Fakultesi Hastanesi Fatma Evyapan Turkey N/A Denizli
Ege Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D. Abdullah Sayiner Turkey N/A Izmir
Sisli Etfal Egitim ve Arastirma Hastanesi Ayda Damar Turkey N/A Istanbul
Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hastanesi Serir Aktogu Turkey N/A Izmir
Uludag Universitesi Gogus Hastaliklari Anabilim Dali Esra Kunt Uzaslan Turkey N/A Bursa
Yedikule Gogus Hastaliklari Hastanesi Saadettin Cikrikcioglu Turkey N/A Istanbul
Dr. Suat Seren Gogus Hastaliklari ve Gogus Cerrahisi Hast. Salih Zeki Guclu Turkey N/A Izmir
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Oznur Yildiz Turkey N/A Ankara
London Chest Hospital Prof Neil C Barnes Great Britain N/A London
Clinical Science Centre Peter Calverley Great Britain N/A Liverpool
University of Cambridge School of Clinical Medicine Edwin Roy Chilvers Great Britain N/A Cambridge
Chesterfield Royal Hospital NHS John William Hadfield Great Britain N/A Chesterfield
Baillieston Health Centre John Langan Great Britain N/A Glasgow
Barnsley Hospital Dr Hazim Mahdi Great Britain N/A Barnsley
Birmingham Heartlands Hospital Adel Mansur Great Britain N/A Birmingham
Respiratory Medicine Alyn Morice Great Britain N/A Hull
West Middlesex University Hospital Andrew Winning Great Britain Middlesex Isleworth
Senior Clinical Lecturer in Respiratory Health Dr Andrew M Wilson Great Britain N/A Norwich
Belfast City Hospital Stuart Elborn Great Britain N/A Belfast
Sunderland Royal Hospital Kishore Sridharan Great Britain N/A Sunderland
Royal Hallamshire Hospital, RFU Rod Lawson Great Britain N/A Sheffield
Heatherwood & Wexham Park Hospitals NHS Foundation Trust Richard Russell Great Britain Berks Windsor
Ashford & St Peter's Hospitals NHS Foundation Trust Monica Nordstrom Great Britain N/A Chertsey
University of the Highlands and Islands Douglas McKeith Great Britain N/A Inverness
UCT Lung Institute Eric Bateman South Africa N/A Cape Town
Tiervlei Trial Centre James Rattray Joubert South Africa N/A Bellville
Gatesville Medical Centre Ismail Abdullah South Africa N/A Cape Town
Tygerberg Hospital Elvis Irusen South Africa N/A Tygerberg
Vergelegen Medi-Clinic Jaco Jansen South Africa N/A Somerset West
Kingsway Medical Centre Mohamed Abdool-Gaffar South Africa N/A Amanzimtoti
Pretoria East Hospital, Moreletapark Gerhard Ras South Africa N/A Pretoria
Woolcock Institute of Medical Research Paul Seale Australia NSW Glebe

伦理委员会信息

名称 审查结论 审查日期
广州医学院第一附属医院伦理委员会 同意 2009-04-27

试验状态信息

试验状态
已完成
目标入组人数
国内: 130 人； 国际: 2488 人；
已入组例数
国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总例数
国内: 130 人 ； 国际: 2488 人；
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：2009-08-13；     国际：2009-06-26；
试验终止日期
国内：2013-10-08；     国际：2013-10-08；

临床试验结果摘要

版本号 版本日期

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