Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
243 participants
INTERVENTIONAL
2010-08-04
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon
NCT02583789
Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon
NCT00700518
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
NCT00528242
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
NCT03867097
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
NCT00419419
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Secondary Raynaud 4 mg dose (period 1)
PF-00489791
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
Secondary Raynaud 4 mg dose (period 2)
PF-00489791
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
Secondary Raynaud 20 mg dose (period 1)
PF-00489791
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
Secondary Raynaud 20 mg dose (period 2)
PF-00489791
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
Primary Raynaud 4 mg dose (period 1)
PF-00489791
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
Primary Raynaud 4 mg dose (period 2)
PF-00489791
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
Primary Raynaud 20 mg dose (period 1)
PF-00489791
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
Primary Raynaud 20 mg dose (period 2)
PF-00489791
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-00489791
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
PF-00489791
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
PF-00489791
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
PF-00489791
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
PF-00489791
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
PF-00489791
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
PF-00489791
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
PF-00489791
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Rheumatology Research Associates
Ottawa, Ontario, Canada
Sir Mortimer B. Davis, Jewish General Hospital
Montreal, Quebec, Canada
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota, Cundinamarca, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Cundinamarca, Colombia
Idearg Sas
Bogotá, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Medicity S.A.S
Bucaramanga, , Colombia
REVMATOLOGIE s.r.o.,
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Revmatologicky ustav
Prague, , Czechia
Dermatologisches Ambulatorium Hamburg-Alstertal
Hamburg, , Germany
Semmelweis Egyetem, Ersebeszeti Klinika
Budapest, , Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
Kecskemét, , Hungary
Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
Szombathely, , Hungary
Unidad de Investigacion en Enfermedades Cronico Degenerativas
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico
Hospital Angeles. Centro Medico del Potosi
San Luis Potosí City, , Mexico
Slaskie Centrum Osteoporozy
Katowice, , Poland
Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
Poznan, , Poland
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
Poznan, , Poland
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw, , Poland
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, , South Korea
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Reumatologkliniken Skanes Universitetssjukhus Lund
Lund, , Sweden
Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Su KY, Sharma M, Kim HJ, Kaganov E, Hughes I, Abdeen MH, Ng JHK. Vasodilators for primary Raynaud's phenomenon. Cochrane Database Syst Rev. 2021 May 17;5(5):CD006687. doi: 10.1002/14651858.CD006687.pub4.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2010-019009-40
Identifier Type: -
Identifier Source: secondary_id
2010-019009-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A7331010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.