EUCTR2014-002796-28-NL进行中（未招募）不适用
The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS
niversity Medical Center Groningen (UMCG)0 个研究点开始时间: 2015年4月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 years or older
- •Systemic sclerosis based on the 2013 ACR/EULAR criteria
- •Raynaud’s phenomenon (RP)
- •A history of digital ulcer disease
- •Assessable Pulse Wave Velocity (PWV) measurement at baseline
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C
- •Baseline values of liver aminotransferases, i.e., aspartate
- •aminotransferases (AST) and/or alanine aminotransferases (ALT), greater
- •than 3 times the upper limit of normal
- •Concomitant use of cyclosporine A
- •Pregnancy
- •Women of child-bearing potential who are not using reliable methods of
- •contraception
- •Significant peripheral vascular disease as the sole consequence of
- •atherosclerotic disease due to for example diabetes, dyslipidemia,
- •systemic hypertension, coagulopathy
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