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Raynaud's DiseasePhase 2NCT01090492

PF-00489791 For The Treatment Of Raynaud's

A Phase 2 study testing PF-00489791 in people with Raynaud's Disease and Peripheral Vascular Disease, run by Pfizer at 55 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
PF-00489791
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
55 sitesin 11 countries
Study dates
4 Aug 2010to 31 May 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

55 sites in 11 countries.

55 sites in 11 countries

United States23 sites

  • The Center for Rheumatology

    Albany, New York, 12206

  • University of Michigan

    Ann Arbor, Michigan, 48106

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Arthritis and Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Johns Hopkins University - Division of Rheumatology

    Baltimore, Maryland, 21224

  • East Penn Rheumatology Associates, PC

    Bethlehem, Pennsylvania, 18015

  • Regional Rheumatology Associates

    Binghamton, New York, 13905

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-5353

  • West Michigan Rheumatology, PLLC

    Grand Rapids, Michigan, 49546

  • Diagnostic Rheumatology and Research, PC

    Indianapolis, Indiana, 46227

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center

    New Brunswick, New Jersey, 08903-0019

  • Stanford Hospital and Outpatient Center

    Redwood City, California, 94063

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057

  • AAIR Research Center

    Rochester, New York, 14618

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61107

  • Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute

    South Bend, Indiana, 46601

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Rheumatic Disease Associates, Ltd.

    Willow Grove, Pennsylvania, 19090

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

Other trials in United States

Colombia5 sites

  • Centro Integral de Reumatologia e Inmunologia CIREI

    Bogota, Cundinamarca, 0000

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogota, Cundinamarca, 0000

  • Idearg Sas

    Bogotá, Cundinamarca, 0000

  • Servimed E.U

    Bucaramanga, Santander Department, 0000

  • Medicity S.A.S

    Bucaramanga, 0000

Other trials in Colombia

Canada4 sites

  • St. Joseph's Health Centre

    London, Ontario, N6A 4V2

  • Sir Mortimer B. Davis, Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Rheumatology Research Associates

    Ottawa, Ontario, K1H 1A2

  • Arthritis Centre Health Sciences Centre

    Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

Poland4 sites

  • Slaskie Centrum Osteoporozy

    Katowice, 40-084

  • Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj

    Poznan, 61-397

  • Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj

    Poznan, 61-397

  • Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

    Wroclaw, 50-368

Other trials in Poland

Czechia3 sites

  • REVMATOLOGIE s.r.o.,

    Brno, 638 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Revmatologicky ustav

    Prague, 128 50

Other trials in Czechia

Hungary3 sites

  • Semmelweis Egyetem, Ersebeszeti Klinika

    Budapest, 1122

  • Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza

    Kecskemét, 6000

  • Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia

    Szombathely, 9700

Other trials in Hungary

Mexico3 sites

  • Unidad de Investigacion en Enfermedades Cronico Degenerativas

    Guadalajara, Jalisco, 44620

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14000

  • Hospital Angeles. Centro Medico del Potosi

    San Luis Potosí City, 78200

Other trials in Mexico

South Korea3 sites

  • Seoul National University Hospital, Rheumatology, Internal Medicine

    Seoul, 110-744

  • Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine

    Seoul, 120-752

  • The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine

    Seoul, 137-701

Other trials in South Korea

Spain3 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

Sweden3 sites

  • CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Reumatologkliniken Skanes Universitetssjukhus Lund

    Lund, 221 85

  • Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken

    Stockholm, 171 76

Other trials in Sweden

Germany1 site

  • Dermatologisches Ambulatorium Hamburg-Alstertal

    Hamburg, 22391

Other trials in Germany

About this study

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

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.

Being tested
PF-00489791
Keywords
Raynaud's phenomenon, vasospasm, scleroderma, systemic sclerosis, CREST, phosphodiesterase inhibitor
Medical subject headings
Raynaud Disease, Peripheral Vascular Diseases, Scleroderma, Diffuse, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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-00489791Drug

    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

Study groups in NCT01090492
Study groupRoleWhat they receive
Secondary Raynaud 4 mg dose (period 1)ExperimentalNot described
Receives: Drug: PF-00489791
Secondary Raynaud 4 mg dose (period 2)ExperimentalNot described
Receives: Drug: PF-00489791
Secondary Raynaud 20 mg dose (period 1)ExperimentalNot described
Receives: Drug: PF-00489791
Secondary Raynaud 20 mg dose (period 2)ExperimentalNot described
Receives: Drug: PF-00489791
Primary Raynaud 4 mg dose (period 1)ExperimentalNot described
Receives: Drug: PF-00489791
Primary Raynaud 4 mg dose (period 2)ExperimentalNot described
Receives: Drug: PF-00489791
Primary Raynaud 20 mg dose (period 1)ExperimentalNot described
Receives: Drug: PF-00489791
Primary Raynaud 20 mg dose (period 2)ExperimentalNot described
Receives: Drug: PF-00489791

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 4

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4

  2. 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.

    Measured: Baseline, Week 4

  3. 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.

    Measured: Baseline, Week 1, 2, 3, 4

  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.

    Measured: Baseline, Day 14, 28

  5. 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.

    Measured: Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)

  6. 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.

    Measured: Screening up to 28 days after last study dose (up to 98 days)

  7. 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.

    Measured: Screening up to 28 days after last study dose (up to 98 days)

  8. 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.

    Measured: Screening up to 28 days after last study dose (up to 98 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2010 (estimated)
  2. Study start4 Aug 2010
  3. Primary completion31 May 2011
  4. Study completion31 May 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090492
Sponsor's protocol ID
A7331010
Other IDs
EudraCT 2010-019009-40, 2010-019009-40
Status last verified
Apr 2018
First submitted
18 Mar 2010
Last updated
16 May 2018
Data monitoring committee
No

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.

    PubMed 33998674

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00489791 in people with Raynaud's Disease and Peripheral Vascular Disease, run by Pfizer at 55 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Colombia, Canada, Poland, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01090492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.

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