NL-OMON45095已完成4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •SSc patients
- •* 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;Healthy controls:
- •* 18 years or older
- •* Written informed consent
排除标准
- •SSc patients:
- •* 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;Healthy controls:
- •* Comorbidities
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