PF-00489791 For The Treatment Of Raynaud's (NCT01090492) | Clinical Trial Compass
CompletedPhase 2
PF-00489791 For The Treatment Of Raynaud's
United States243 participantsStarted 2010-08-04
Plain-language summary
The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4