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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02050360
Eligibility Criteria:
Inclusion Criteria:
* Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
* At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
* Patients who have dated and signed the informed consent form
* Contraception for women
Exclusion Criteria:
* Recently diagnosed RP (less than 2 months).
* Uncontrolled hypertension, diabetes mellitus, angina
* Haemodynamic instability
* Nonarteritic ischemic optic neuropathy
* Pulmonary hypertension
* Subjects currently taking sildenafil, tadalafil or vardenafil
* Subjects currently taking nitrates
* Subjects currently taking strong CYP3A inhibitors
* Pregnancy (or considering pregnancy in the next 4 months)
* Breast feeding
* Participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02050360
Study Brief:
Protocol Section:
NCT02050360