PF-00489791 For The Treatment Of Raynaud's

NCT01090492 | Completed Phase 2 Results

• 3 other identifiers: A7331010EudraCT 2010-019009-402010-019009-40
• Study Type: interventional
• Target: 243
• Locations: 11 countries
• Sites: 55

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.

Conditions

Raynaud's Disease; Peripheral Vascular Disease

Keywords

Raynaud's phenomenon; vasospasm; scleroderma; systemic sclerosis; CREST; phosphodiesterase inhibitor

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 4

Secondary Outcomes (8)

• Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4

  Baseline, Week 1, Week 2, Week 3, Week 4

• Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4

  Baseline, Week 4

• Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4

  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

  Baseline, Day 14, 28

• Plasma Concentration of PF-00489791 and Its Metabolites

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

Study Arms (8)

Secondary Raynaud 4 mg dose (period 1)

EXPERIMENTAL

Drug: PF-00489791

Secondary Raynaud 4 mg dose (period 2)

EXPERIMENTAL

Drug: PF-00489791

Secondary Raynaud 20 mg dose (period 1)

EXPERIMENTAL

Drug: PF-00489791

Secondary Raynaud 20 mg dose (period 2)

EXPERIMENTAL

Drug: PF-00489791

Primary Raynaud 4 mg dose (period 1)

EXPERIMENTAL

Drug: PF-00489791

Primary Raynaud 4 mg dose (period 2)

EXPERIMENTAL

Drug: PF-00489791

Primary Raynaud 20 mg dose (period 1)

EXPERIMENTAL

Drug: PF-00489791

Primary Raynaud 20 mg dose (period 2)

EXPERIMENTAL

Drug: PF-00489791

Interventions

PF-00489791 DRUG

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 1)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (55)

Stanford Hospital and Outpatient Center

Redwood City, California, 94063, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030-5353, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Arthritis and Rheumatology of Georgia

Atlanta, Georgia, 30342, United States

Location

Rockford Orthopedic Associates

Rockford, Illinois, 61107, United States

Location

Diagnostic Rheumatology and Research, PC

Indianapolis, Indiana, 46227, United States

Location

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

South Bend, Indiana, 46601, United States

Location

Johns Hopkins University - Division of Rheumatology

Baltimore, Maryland, 21224, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

West Michigan Rheumatology, PLLC

Grand Rapids, Michigan, 49546, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center

New Brunswick, New Jersey, 08903-0019, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

Regional Rheumatology Associates

Binghamton, New York, 13905, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

East Penn Rheumatology Associates, PC

Bethlehem, Pennsylvania, 18015, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Rheumatic Disease Associates, Ltd.

Willow Grove, Pennsylvania, 19090, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

Arthritis Centre Health Sciences Centre

Winnipeg, Manitoba, R3A 1M4, Canada

Location

St. Joseph's Health Centre

London, Ontario, N6A 4V2, Canada

Location

Rheumatology Research Associates

Ottawa, Ontario, K1H 1A2, Canada

Location

Sir Mortimer B. Davis, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centro Integral de Reumatologia e Inmunologia CIREI

Bogota, Cundinamarca, 0000, Colombia

Location

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota, Cundinamarca, 0000, Colombia

Location

Idearg Sas

Bogotá, Cundinamarca, 0000, Colombia

Location

Servimed E.U

Bucaramanga, Santander Department, 0000, Colombia

Location

Medicity S.A.S

Bucaramanga, 0000, Colombia

Location

REVMATOLOGIE s.r.o.,

Brno, 638 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Dermatologisches Ambulatorium Hamburg-Alstertal

Hamburg, 22391, Germany

Location

Semmelweis Egyetem, Ersebeszeti Klinika

Budapest, 1122, Hungary

Location

Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza

Kecskemét, 6000, Hungary

Location

Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia

Szombathely, 9700, Hungary

Location

Unidad de Investigacion en Enfermedades Cronico Degenerativas

Guadalajara, Jalisco, 44620, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

Hospital Angeles. Centro Medico del Potosi

San Luis Potosí City, 78200, Mexico

Location

Slaskie Centrum Osteoporozy

Katowice, 40-084, Poland

Location

Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj

Poznan, 61-397, Poland

Location

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

Poznan, 61-397, Poland

Location

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

Wroclaw, 50-368, Poland

Location

Seoul National University Hospital, Rheumatology, Internal Medicine

Seoul, 110-744, South Korea

Location

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

Seoul, 120-752, South Korea

Location

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

Seoul, 137-701, South Korea

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Reumatologkliniken Skanes Universitetssjukhus Lund

Lund, 221 85, Sweden

Location

Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33998674 DERIVED

Related Links

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

MeSH Terms

Conditions

Raynaud Disease; Peripheral Vascular Diseases; Scleroderma, Diffuse; Scleroderma, Systemic

Interventions

PF-00489791

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases

Limitations and Caveats

Plasma concentration of PF-00489791 metabolites was not intended as secondary endpoint in the protocol and was considered as an exploratory endpoint.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 22, 2010
• Study Start: August 4, 2010
• Primary Completion: May 31, 2011
• Study Completion: May 31, 2011
• Last Updated: May 16, 2018
• Results First Posted: May 16, 2018

Record last verified: 2018-04

Locations

CO (5); US (23); CZ (3); DE (1); ES (3); SE (3); ME (3); CA (4); HU (3); KR (3); PL (4)