PF-00489791 For The Treatment Of Raynaud's

Completed · Phase 2 · Has a placebo group

Conditions studied: Raynaud's Disease, Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT01090492

Run by

Pfizer

People needed

243

Starts

2010-08-04

Expected to finish

2011-05-31

Last updated by the study team

2018-05-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Arthritis and Rheumatology of Georgia — Atlanta, Georgia, United States
• Rockford Orthopedic Associates — Rockford, Illinois, United States
• Diagnostic Rheumatology and Research, PC — Indianapolis, Indiana, United States
• Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute — South Bend, Indiana, United States
• Johns Hopkins University - Division of Rheumatology — Baltimore, Maryland, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• West Michigan Rheumatology, PLLC — Grand Rapids, Michigan, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center — New Brunswick, New Jersey, United States
• The Center for Rheumatology — Albany, New York, United States
• Regional Rheumatology Associates — Binghamton, New York, United States
• AAIR Research Center — Rochester, New York, United States
• East Penn Rheumatology Associates, PC — Bethlehem, Pennsylvania, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Rheumatic Disease Associates, Ltd. — Willow Grove, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, United States
• Arthritis Centre Health Sciences Centre — Winnipeg, Manitoba, Canada
• St. Joseph's Health Centre — London, Ontario, Canada
• Stanford Hospital and Outpatient Center — Redwood City, California, United States

Full record on ClinicalTrials.gov

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