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PF-00489791 For The Treatment Of Raynaud's

Primary Purpose

Raynaud's Disease, Peripheral Vascular Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Disease focused on measuring Raynaud's phenomenon, vasospasm, scleroderma, systemic sclerosis, CREST, phosphodiesterase inhibitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford Hospital and Outpatient Center
  • University of Connecticut Health Center
  • Georgetown University Hospital
  • Arthritis and Rheumatology of Georgia
  • Rockford Orthopedic Associates
  • Diagnostic Rheumatology and Research, PC
  • Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute
  • Johns Hopkins University - Division of Rheumatology
  • The Center for Rheumatology and Bone Research
  • Clinical Pharmacology Study Group
  • University of Michigan
  • University of Michigan Health System
  • West Michigan Rheumatology, PLLC
  • Physician Research Collaboration, LLC
  • UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
  • The Center for Rheumatology
  • Regional Rheumatology Associates
  • AAIR Research Center
  • East Penn Rheumatology Associates, PC
  • Altoona Center for Clinical Research
  • Rheumatic Disease Associates, Ltd.
  • Metroplex Clinical Research Center
  • Rainier Clinical Research Center, Inc.
  • Arthritis Centre Health Sciences Centre
  • St. Joseph's Health Centre
  • Rheumatology Research Associates
  • Sir Mortimer B. Davis, Jewish General Hospital
  • Centro Integral de Reumatologia e Inmunologia CIREI
  • Fundacion Instituto de Reumatologia Fernando Chalem
  • Idearg Sas
  • Servimed E.U
  • Medicity S.A.S
  • REVMATOLOGIE s.r.o.,
  • Fakultni nemocnice Hradec Kralove
  • Revmatologicky ustav
  • Dermatologisches Ambulatorium Hamburg-Alstertal
  • Semmelweis Egyetem, Ersebeszeti Klinika
  • Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
  • Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
  • Seoul National University Hospital, Rheumatology, Internal Medicine
  • Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
  • The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Unidad de Investigacion en Enfermedades Cronico Degenerativas
  • Hospital Angeles. Centro Medico del Potosi
  • Slaskie Centrum Osteoporozy
  • Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
  • Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
  • Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
  • Hospital Clinico Universitario Santiago de Compostela
  • Hospital Del Mar
  • Hospital Universitario 12 de Octubre
  • CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
  • Reumatologkliniken Skanes Universitetssjukhus Lund
  • Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Secondary Raynaud 4 mg dose (period 1)

Secondary Raynaud 4 mg dose (period 2)

Secondary Raynaud 20 mg dose (period 1)

Secondary Raynaud 20 mg dose (period 2)

Primary Raynaud 4 mg dose (period 1)

Primary Raynaud 4 mg dose (period 2)

Primary Raynaud 20 mg dose (period 1)

Primary Raynaud 20 mg dose (period 2)

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.

Secondary Outcome Measures

Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.
Plasma Concentration of PF-00489791 and Its Metabolites
Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.
Number of Participants With Laboratory Test Abnormalities
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.
Number of Participants With Abnormal Electrocardiogram (ECG) Values
ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.

Full Information

First Posted
March 18, 2010
Last Updated
April 16, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01090492
Brief Title
PF-00489791 For The Treatment Of Raynaud's
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 4, 2010 (Actual)
Primary Completion Date
May 31, 2011 (Actual)
Study Completion Date
May 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease, Peripheral Vascular Disease
Keywords
Raynaud's phenomenon, vasospasm, scleroderma, systemic sclerosis, CREST, phosphodiesterase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secondary Raynaud 4 mg dose (period 1)
Arm Type
Experimental
Arm Title
Secondary Raynaud 4 mg dose (period 2)
Arm Type
Experimental
Arm Title
Secondary Raynaud 20 mg dose (period 1)
Arm Type
Experimental
Arm Title
Secondary Raynaud 20 mg dose (period 2)
Arm Type
Experimental
Arm Title
Primary Raynaud 4 mg dose (period 1)
Arm Type
Experimental
Arm Title
Primary Raynaud 4 mg dose (period 2)
Arm Type
Experimental
Arm Title
Primary Raynaud 20 mg dose (period 1)
Arm Type
Experimental
Arm Title
Primary Raynaud 20 mg dose (period 2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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 Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
Description
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Description
Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4
Title
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Description
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
Time Frame
Baseline, Week 4
Title
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Description
Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.
Time Frame
Baseline, Week 1, 2, 3, 4
Title
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
Description
Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.
Time Frame
Baseline, Day 14, 28
Title
Plasma Concentration of PF-00489791 and Its Metabolites
Description
Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.
Time Frame
Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)
Title
Number of Participants With Laboratory Test Abnormalities
Description
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Time Frame
Screening up to 28 days after last study dose (up to 98 days)
Title
Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
Description
Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.
Time Frame
Screening up to 28 days after last study dose (up to 98 days)
Title
Number of Participants With Abnormal Electrocardiogram (ECG) Values
Description
ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.
Time Frame
Screening up to 28 days after last study dose (up to 98 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Hospital and Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-5353
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Arthritis and Rheumatology of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rockford Orthopedic Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Diagnostic Rheumatology and Research, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Johns Hopkins University - Division of Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
West Michigan Rheumatology, PLLC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0019
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Regional Rheumatology Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
East Penn Rheumatology Associates, PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Rheumatic Disease Associates, Ltd.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rainier Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Arthritis Centre Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
Facility Name
St. Joseph's Health Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Rheumatology Research Associates
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Sir Mortimer B. Davis, Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centro Integral de Reumatologia e Inmunologia CIREI
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Fundacion Instituto de Reumatologia Fernando Chalem
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Idearg Sas
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Servimed E.U
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Medicity S.A.S
City
Bucaramanga
ZIP/Postal Code
0000
Country
Colombia
Facility Name
REVMATOLOGIE s.r.o.,
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Dermatologisches Ambulatorium Hamburg-Alstertal
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Semmelweis Egyetem, Ersebeszeti Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Seoul National University Hospital, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Unidad de Investigacion en Enfermedades Cronico Degenerativas
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Hospital Angeles. Centro Medico del Potosi
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Slaskie Centrum Osteoporozy
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Hospital Clinico Universitario Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Reumatologkliniken Skanes Universitetssjukhus Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33998674
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331010&StudyName=PF-00489791%20For%20The%20Treatment%20Of%20Raynaud%27s
Description
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Learn more about this trial

PF-00489791 For The Treatment Of Raynaud's

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