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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Raynaud's Disease
• Intervention / Treatment: Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791; Drug: PF-00489791

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Arthritis Centre Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Centre
    • Ottawa, Ontario, Canada, K1H 1A2
      • Rheumatology Research Associates
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis, Jewish General Hospital
• Colombia
  • Bucaramanga, Colombia, 0000
    • Medicity S.A.S
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Centro Integral de Reumatologia e Inmunologia CIREI
    • Bogota, Cundinamarca, Colombia, 0000
      • Fundacion Instituto de Reumatologia Fernando Chalem
    • Bogotá, Cundinamarca, Colombia, 0000
      • Idearg Sas
  • Santander
    • Bucaramanga, Santander, Colombia, 0000
      • Servimed E.U
• Czechia
  • Brno, Czechia, 638 00
    • REVMATOLOGIE s.r.o.,
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Praha 2, Czechia, 128 50
    • Revmatologicky ustav
• Germany
  • Hamburg, Germany, 22391
    • Dermatologisches Ambulatorium Hamburg-Alstertal
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem, Ersebeszeti Klinika
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
  • Szombathely, Hungary, 9700
    • Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
• Mexico
  • San Luis Potosi, Mexico, 78200
    • Hospital Angeles. Centro Medico del Potosi
  • DF
    • Mexico, DF, Mexico, 14000
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44620
      • Unidad de Investigacion en Enfermedades Cronico Degenerativas
• Poland
  • Katowice, Poland, 40-084
    • Slaskie Centrum Osteoporozy
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
  • Wroclaw, Poland, 50-368
    • Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
• Sweden
  • Goteborg, Sweden, 413 45
    • CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
  • Lund, Sweden, 221 85
    • Reumatologkliniken Skanes Universitetssjukhus Lund
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken
• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Hospital and Outpatient Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030-5353
      • University of Connecticut Health Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Arthritis and Rheumatology of Georgia
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Orthopedic Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Diagnostic Rheumatology And Research, PC
    • South Bend, Indiana, United States, 46601
      • Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University - Division of Rheumatology
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49546
      • West Michigan Rheumatology, PLLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903-0019
      • UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
  • New York
    • Albany, New York, United States, 12206
      • The Center for Rheumatology
    • Binghamton, New York, United States, 13905
      • Regional Rheumatology Associates
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • East Penn Rheumatology Associates, Pc
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Willow Grove, Pennsylvania, United States, 19090
      • Rheumatic Disease Associates, Ltd.
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Secondary Raynaud 4 mg dose (period 1)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Secondary Raynaud 4 mg dose (period 2)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Secondary Raynaud 20 mg dose (period 1)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Secondary Raynaud 20 mg dose (period 2)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Primary Raynaud 4 mg dose (period 1)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Primary Raynaud 4 mg dose (period 2)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Primary Raynaud 20 mg dose (period 1)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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
EXPERIMENTAL: Primary Raynaud 20 mg dose (period 2)	Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 1, Week 2, Week 3, Week 4
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.	Baseline, Week 4
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.	Baseline, Week 1, 2, 3, 4
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.	Baseline, Day 14, 28
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.	Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)
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.	Screening up to 28 days after last study dose (up to 98 days)
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.	Screening up to 28 days after last study dose (up to 98 days)
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.	Screening up to 28 days after last study dose (up to 98 days)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 4, 2010
• Primary Completion (ACTUAL): May 31, 2011
• Study Completion (ACTUAL): May 31, 2011

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (ESTIMATE): March 22, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: vasospasm; systemic sclerosis; scleroderma; phosphodiesterase inhibitor; CREST; Raynaud's phenomenon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Raynaud Disease
• Other Study ID Numbers: A7331010; EudraCT 2010-019009-40; 2010-019009-40 (EUDRACT_NUMBER)