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COMPLETEDPHASE2

PF-00489791 For The Treatment Of Raynaud's

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

NCT01090492•Pfizer

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (55)

Stanford Hospital and Outpatient Center

Redwood City, California, United States

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

Key Dates

Start Date

August 4, 2010

Primary Completion Date

May 31, 2011

Completion Date

May 31, 2011

Last Updated

May 16, 2018

Enrollment

243

ACTUAL participants

Conditions

Raynaud's DiseasePeripheral Vascular Disease

Interventions

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

PF-00489791

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PF-00489791 For The Treatment Of Raynaud's

Inclusion Criteria

Exclusion Criteria

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Fisetin to Reduce Senescence and Mobility Impairment in PAD

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