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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT01090492
Eligibility Criteria:
Inclusion Criteria:
* Active Raynaud's Phenomenon
* Stable disease and medication requirements over the previous two months
* For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome
* both sexes
Exclusion Criteria:
* Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates
* Smoking within 3 months or smoking cessation using nicotine products
* Subjects currently taking sildenafil, tadalafil or vardenafil
* Subjects with ulnar arterial occlusive disease as shown by a modified Allen test
* Pregnant or breast feeding or considering pregnancy in next 4 months
* Participation in trial for investigational drug within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01090492
Study Brief:
Protocol Section:
NCT01090492