此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

2012年3月29日 更新者：Pfizer

A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

研究概览

地位

终止

条件

干预/治疗

详细说明

Open-label extension

研究类型

介入性

注册 (实际的)

1192

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Petach Tikva、以色列、49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan、以色列、52601
        • Pfizer Investigational Site
  • 加拿大
      • Quebec、加拿大、G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary、Alberta、加拿大、T1Y 6J4
        • Pfizer Investigational Site
      • Edmonton、Alberta、加拿大、T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Pfizer Investigational Site
    • Ontario
      • London、Ontario、加拿大、N6A 4G5
        • Pfizer Investigational Site
      • Toronto、Ontario、加拿大、M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • Pfizer Investigational Site
  • 墨西哥
    • CP
      • Monterrey、CP、墨西哥、64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan、DF、墨西哥、14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey、N.l.、墨西哥、64360
        • Pfizer Investigational Site
  • 奥地利
      • Graz、奥地利、8036
        • Pfizer Investigational Site
      • Wien、奥地利、1090
        • Pfizer Investigational Site
  • 巴西
      • Sao Paulo、巴西、05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte、MG、巴西、30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre、RS、巴西、90035-003
        • Pfizer Investigational Site
  • 德国
      • Berlin、德国、14050
        • Pfizer Investigational Site
      • Dresden、德国、01307
        • Pfizer Investigational Site
      • Giessen、德国、35392
        • Pfizer Investigational Site
      • Greifswald、德国、17487
        • Pfizer Investigational Site
      • Hannover、德国、30625
        • Pfizer Investigational Site
      • Heidelberg、德国、69120
        • Pfizer Investigational Site
      • Leipzig、德国、04103
        • Pfizer Investigational Site
      • Regensburg、德国、93053
        • Pfizer Investigational Site
  • 意大利
      • Bologna、意大利、40138
        • Pfizer Investigational Site
  • 比利时
      • Bruxelles、比利时、1070
        • Pfizer Investigational Site
      • Leuven、比利时、B - 3000
        • Pfizer Investigational Site
  • 法国
      • Clamart Cedex、法国、92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09、法国、38043
        • Pfizer Investigational Site
      • Strasbourg、法国、67098
        • Pfizer Investigational Site
  • 波兰
      • Krakow、波兰、31-202
        • Pfizer Investigational Site
      • Warszawa、波兰、01-138
        • Pfizer Investigational Site
      • Zabrze、波兰、41-800
        • Pfizer Investigational Site
  • 澳大利亚
      • Chermside、澳大利亚、QLD 4032
        • Pfizer Investigational Site
    • New South Wales
      • Darlinghurst、New South Wales、澳大利亚、2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside Q、Queensland、澳大利亚、4032
        • Pfizer Investigational Site
    • Victoria
      • Melbourne、Victoria、澳大利亚、3004
        • Pfizer Investigational Site
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • Pfizer Investigational Site
      • Birmingham、Alabama、美国、35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix、Arizona、美国、85013
        • Pfizer Investigational Site
    • California
      • Los Angeles、California、美国、90073
        • Pfizer Investigational Site
      • San Francisco、California、美国、94143-0124
        • Pfizer Investigational Site
      • Torrence、California、美国、90502
        • Pfizer Investigational Site
    • Colorado
      • Denver、Colorado、美国、80262
        • Pfizer Investigational Site
      • Denver、Colorado、美国、80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota、Florida、美国、34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Pfizer Investigational Site
      • Augusta、Georgia、美国、30912
        • Pfizer Investigational Site
      • Decatur、Georgia、美国、30033
        • Pfizer Investigational Site
      • Decatur、Georgia、美国、30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City、Kansas、美国、66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Pfizer Investigational Site
      • New Orleans、Louisiana、美国、70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland、Maine、美国、04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore、Maryland、美国、21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • Pfizer Investigational Site
      • Boston、Massachusetts、美国、02114
        • Pfizer Investigational Site
      • Boston、Massachusetts、美国、02111
        • Pfizer Investigational Site
      • Boston、Massachusetts、美国、02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0570
        • Pfizer Investigational Site
      • Detroit、Michigan、美国、48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick、New Jersey、美国、08903-0019
        • Pfizer Investigational Site
    • New York
      • New York、New York、美国、10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland、Ohio、美国、44106
        • Pfizer Investigational Site
      • Cleveland、Ohio、美国、44195
        • Pfizer Investigational Site
      • Columbus、Ohio、美国、43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • Pfizer Investigational Site
      • Pittsburgh、Pennsylvania、美国、15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Pfizer Investigational Site
      • Nashville、Tennessee、美国、37232-5735
        • Pfizer Investigational Site
      • Nashville、Tennessee、美国、37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston、Texas、美国、77555-0561
        • Pfizer Investigational Site
      • Houston、Texas、美国、77030
        • Pfizer Investigational Site
      • San Antonio、Texas、美国、78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City、Utah、美国、84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Pfizer Investigational Site
      • Milwaukee、Wisconsin、美国、53215
        • Pfizer Investigational Site
  • 英国
      • Glasgow、英国、G11 6NT
        • Pfizer Investigational Site
      • London、英国、NW3 2QG
        • Pfizer Investigational Site
      • Newcastle、英国、NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard、Cambridgeshire、英国、CB3 8RB
        • Pfizer Investigational Site
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • Pfizer Investigational Site
  • 西班牙
      • Barcelona、西班牙、08036
        • Pfizer Investigational Site
  • 阿根廷
      • Capital Federal、阿根廷、C1039AAO
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal、Buenos Aires、阿根廷、C1416ASA
        • Pfizer Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 75年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
  • Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

  • Has portal hypertension or chronic liver disease.
  • Has history of left sided heart disease or significant cardiac disease.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Sitaxsentan
药品：Sitaxsentan
Sitaxsentan 100 mg tablets once daily
其他名称：
  • Sitaxentan

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Day 1 up to 82 months
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Day 1 up to 82 months
The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Total Bilirubin > 1.5 x ULN
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
大体时间：Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Anticoagulant Use
大体时间：Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Elevated International Normalize Ratio (INR)
大体时间：Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
大体时间：Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
大体时间：Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Percentage of Participants With Abnormal Prothrombin Time (PT)
大体时间：Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
大体时间：Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年3月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2008年12月9日

首先提交符合 QC 标准的

2008年12月16日

首次发布 (估计)

2008年12月18日

研究记录更新

最后更新发布 (估计)

2012年4月24日

上次提交的符合 QC 标准的更新

2012年3月29日

最后验证

2011年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B1321007
  • FPH03

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Sitaxsentan的临床试验

  • Pfizer
    终止
    Sitaxsentan 疗效和安全性试验，随机前瞻性评估添加西地那非 (SR-PAAS)
    肺动脉高压 | 肺动脉高压
    美国, 保加利亚, 阿根廷, 智利, 中国, 哥伦比亚, 哥斯达黎加, 捷克共和国, 多明尼加共和国, 危地马拉, 印度, 马来西亚, 墨西哥, 秘鲁, 菲律宾, 罗马尼亚, 俄罗斯联邦, 沙特阿拉伯, 塞尔维亚, 斯洛伐克, 南非, 泰国, 火鸡, 乌克兰
  • West Penn Allegheny Health System
    Johns Hopkins University; University of Colorado, Denver; Massachusetts General Hospital; Mayo Clinic 和其他合作者
    撤销
    肺动脉高压的药物基因组学
    肺动脉高压 | 肺动脉高压 | PAH 世卫组织第一组
    美国

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Gabon

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅