PF-00489791 For The Treatment Of Raynaud's
Condition: Raynaud's Disease; Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Raynaud Disease
Intervention: PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791
Intervention description: Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Raynaud's phenomenon; vasospasm; scleroderma; systemic sclerosis; CREST; phosphodiesterase inhibitor

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.
    

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