Conditions: Raynaud's Disease Peripheral Vascular Disease
Keywords: Raynaud's phenomenon vasospasm scleroderma systemic sclerosis CREST phosphodiesterase inhibitor
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 243
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

Interventions: intervention 1: PF-00489791 intervention 2: PF-00489791 intervention 3: PF-00489791 intervention 4: PF-00489791 intervention 5: PF-00489791 intervention 6: PF-00489791 intervention 7: PF-00489791 intervention 8: PF-00489791
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: 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 intervention 4: 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 intervention 5: 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 intervention 6: 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 intervention 7: 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 intervention 8: 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

Protocol document: