PF-00489791 For The Treatment Of Raynaud's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01090492
First received: March 18, 2010
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Raynaud's Disease
Peripheral Vascular Disease
Drug: PF-00489791
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Phenomen

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in the Raynaud's Condition Score during the fourth week of treatment from baseline, comparing active drug to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the number of Raynaud's Phenomenon attacks per week during the fourth week of treatment compared to the number of Raynaud's Phenomenon attacks week at baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change in the total duration of Raynaud's Phenomenon attacks per week during the fourth week of treatment compared to the total duration of Raynaud's Phenomenon attacks per week at baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Improvements in Raynaud's pain score comparing active to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Decrease ulcer burden in secondary Raynaud's Phenomenon patients by hastening healing or preventing new ulcer emergence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma concentration of PF-00489791 and metabolites [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety and tolerability of PF-00489791 as assessed by incidences of treatment emergent adverse events and changes from baseline for clinical laboratory tests, vital signs, orthostatic blood pressure measurements and 12-lead ECG parameters [ Time Frame: 98 days ] [ Designated as safety issue: Yes ]

Enrollment: 243
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Secondary Raynaud 4 mg dose (period 2) 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
Experimental: Secondary Raynaud 20 mg dose (period 1) 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
Experimental: Secondary Raynaud 20 mg dose (period 2) 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
Experimental: Primary Raynaud 4 mg dose (period 1) 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
Experimental: Primary Raynaud 4 mg dose (period 2) 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
Experimental: Primary Raynaud 20 mg dose (period 1) 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
Experimental: Primary Raynaud 20 mg dose (period 2) 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090492

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Redwood City, California, United States, 94063
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030-5353
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46227
Pfizer Investigational Site
South Bend, Indiana, United States, 46601
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21224
Pfizer Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48106
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49546
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903-0019
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12206
Pfizer Investigational Site
Binghamton, New York, United States, 13905
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, Pennsylvania
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
United States, Washington
Pfizer Investigational Site
Renton, Washington, United States, 98057
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M4
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4V2
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 1A2
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia, 0000
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia, 0000
Pfizer Investigational Site
Bucaramanga, Santander, Colombia, 0000
Pfizer Investigational Site
Bucaramanga, Colombia, 0000
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 638 00
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 05
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Germany
Pfizer Investigational Site
Hamburg, Germany, 22391
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1122
Pfizer Investigational Site
Kecskemet, Hungary, 6000
Pfizer Investigational Site
Szombathely, Hungary, 9700
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 14000
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44620
Pfizer Investigational Site
San Luis Potosi, Mexico, 78200
Poland
Pfizer Investigational Site
Katowice, Poland, 40-084
Pfizer Investigational Site
Poznan, Poland, 61-397
Pfizer Investigational Site
Wroclaw, Poland, 50-368
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15706
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Madrid, Spain, 28041
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01090492     History of Changes
Other Study ID Numbers: A7331010, EudraCT 2010-019009-40
Study First Received: March 18, 2010
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Raynaud's phenomenon
vasospasm
scleroderma
systemic sclerosis
CREST
phosphodiesterase inhibitor

Additional relevant MeSH terms:
Raynaud Disease
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Phosphodiesterase Inhibitors
Phosphodiesterase 5 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014