PF-00489791 For The Treatment Of Raynaud's



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:5/18/2018
Start Date:August 4, 2010
End Date:May 31, 2011

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A Phase 2a Randomized Double-blinded, Placebo And Active Controlled Two Cohort Two Doses Cross-over Multi-center Clinical Study To Assess Efficacy Of A Once Daily Administration Of A Phosphodiesterase 5 Inhibitor (Pf-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomenon

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.


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
We found this trial at
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Albany, New York 12206
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30342
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Bethlehem, Pennsylvania 18015
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Binghamton, New York 13905
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Duncansville, Pennsylvania 16635
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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Grand Rapids, Michigan 49546
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Indianapolis, Indiana 46227
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Indianapolis, IN
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Lincoln, Nebraska 68512
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Redwood City, California 94063
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Renton, Washington 98057
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Rochester, New York 14618
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Rockford, Illinois 61107
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington,
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Willow Grove, Pennsylvania 19090
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Worcester, Massachusetts 01610
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