Clinical trial NCT01090492: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud's Disease
Peripheral Vascular Disease
Keywords: Raynaud's phenomenon
vasospasm
scleroderma
systemic sclerosis
CREST
phosphodiesterase inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
timeFrame: Baseline, Day 14, 28
measure: Plasma Concentration of PF-00489791 and Its Metabolites
timeFrame: Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening up to 28 days after last study dose (up to 98 days)
measure: Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
timeFrame: Screening up to 28 days after last study dose (up to 98 days)
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Values
timeFrame: Screening up to 28 days after last study dose (up to 98 days)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Hospital and Outpatient Center
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Arthritis and Rheumatology of Georgia
state: Georgia
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research, PC
state: Indiana
city: South Bend
country: United States
facility: Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University - Division of Rheumatology
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Grand Rapids
country: United States
facility: West Michigan Rheumatology, PLLC
state: Michigan
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
state: New Jersey
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
city: Binghamton
country: United States
facility: Regional Rheumatology Associates
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates, Ltd.
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Winnipeg
country: Canada
facility: Arthritis Centre Health Sciences Centre
state: Manitoba
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: Rheumatology Research Associates
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis, Jewish General Hospital
state: Quebec
city: Bogota
country: Colombia
facility: Centro Integral de Reumatologia e Inmunologia CIREI
state: Cundinamarca
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Idearg Sas
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed E.U
state: Santander
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S
city: Brno
country: Czechia
facility: REVMATOLOGIE s.r.o.,
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Hamburg
country: Germany
facility: Dermatologisches Ambulatorium Hamburg-Alstertal
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Ersebeszeti Klinika
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas
state: Jalisco
city: San Luis Potosi
country: Mexico
facility: Hospital Angeles. Centro Medico del Potosi
city: Katowice
country: Poland
facility: Slaskie Centrum Osteoporozy
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
city: Wroclaw
country: Poland
facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: A Coruña
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Goteborg
country: Sweden
facility: CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: Reumatologkliniken Skanes Universitetssjukhus Lund
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna, Reumatologiska kliniken
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.