PF-00489791 For The Treatment Of Raynaud's

• Status: Completed
• Trial end date: 2011-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Phosphodiesterase 5 Inhibitors

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