A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
NCT ID: NCT00853112
Last Updated: 2017-10-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2009-04-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PF-00489791 1 mg
PF-00489791
tablet form, 1 mg, single dose (Day 1)
PF-00489791 2 mg
PF-00489791
tablet form, 2 mg, single dose (Day 1)
PF-00489791 4 mg
PF-00489791
tablet form, 4 mg, single dose (Day 1)
PF-00489791 10 mg
PF-00489791
tablet form, 10 mg, single dose (Day 1)
PF-00489791 20 mg
PF-00489791
tablet form, 20 mg, single dose (Day 1)
Placebo
placebo
tablet form, single dose (Day 1)
Sildenafil
Observational comparator arm
sildenafil
tablet form, 20 mg, single dose (Day 1)
Interventions
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PF-00489791
tablet form, 1 mg, single dose (Day 1)
PF-00489791
tablet form, 2 mg, single dose (Day 1)
PF-00489791
tablet form, 4 mg, single dose (Day 1)
PF-00489791
tablet form, 10 mg, single dose (Day 1)
PF-00489791
tablet form, 20 mg, single dose (Day 1)
placebo
tablet form, single dose (Day 1)
sildenafil
tablet form, 20 mg, single dose (Day 1)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean PAP at least 25 mm Hg, PCWP \< 15 mm Hg at rest
* For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
* Signed and dated informed consent
* Willingness to comply with the study plan and procedures
Exclusion Criteria
* For females, pregnancy or lactation
* Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
* Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
* Large shift in altitude (defined as \>5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
* Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
* HIV positive subjects
* Subjects participating in another clinical trial with an investigational drug or device
* Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
* Allergies and previous intolerance of PDE5 inhibitors
* Alcohol or drug abuse
* Blood donation during the study, or 1 month before or after the study
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
John C. Lincoln Hospital, North Mountain
Phoenix, Arizona, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Shands at University of Florida
Gainesville, Florida, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center - Department of Internal Medicine Pulmonary
Dallas, Texas, United States
UT Southwestern St. Paul Hospital
Dallas, Texas, United States
Lawson Health Research Institute
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Sir Mortimer B. Davis, Jewish General Hospital
Montreal, Quebec, Canada
Thoraxklinik am Universitaetsklinikum
Heidelberg, , Germany
Department Of Cardiology, MediCiti Hospital,
Hyderabad, Andhra Pardesh, India
Department Of Cardiology, Sri Venkateswara Institute Of Medical Sciences
Tirupati, Andhra Pardesh, India
Bankers Heart Institute
Vadodara, Gujarat, India
Omega Hospital
Mangalore, Karnataka, India
Moscow Healthcare Institution "City Clinical Hospital No. 57"
Moscow, , Russia
Institute of Cardiosurgery n.a. V.I.Burakovsky
Moscow, , Russia
Hospital General Universitari Vall D´Hebron
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Universitetssjukhuset i Lund, Hjart- och Lungdivisionen
Lund, , Sweden
Norrlands Universitetssjukhus, Kliniskt Forsknings Centrum
Umeå, , Sweden
Akademiska Sjukhuset, Kardiologen 50F/Forskningsenheten
Uppsala, , Sweden
Universitaetsspittal Zuerich, Medizinische Klinik A
Zurich, , Switzerland
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2008-003572-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A7331009
Identifier Type: -
Identifier Source: org_study_id