Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT02480335
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Systemic sclerosis based on the 2013 American College of Rheumatology/European League Against Rheumatism criteria
* Raynaud's phenomenon
* A history of digital ulcer disease
* Assessable Pulse Wave Velocity measurement at baseline
* Written informed consent
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients
* Systolic blood pressure lower than 85 mmHg
* Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C
* Baseline values of liver aminotransferases, i.e., aspartate aminotransferases and/or alanine aminotransferases, 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 conventional vascular risk factors and coagulopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02480335
Study Brief:
Protocol Section:
NCT02480335