Health Condition 1: null- Hypertension, Pulmonary
Conditions
Interventions
Intervention1: PF-00489791 1mg: tablet form, 1 mg, single dose (Day 1)
Intervention2: PF-00489791 2 mg: tablet form, 2 mg, single dose (Day 1)
Intervention3: PF-00489791 4 mg: tablet form, 4 mg, singl
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: a. Ages Eligible for Study: 18 Years and older, b. Genders Eligible for Study: Both, c. Accepts Healthy Volunteers: No, 1.Idiopathic or familial pulmonary arterial hypertension (PAH) 2.Mean PAP at least 25 mm Hg, PCWP lessthan 15 mm Hg at rest 3.For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion 4.Signed and dated informed consent 5.Willingness to comply with the study plan and procedures There is no upper age limit for inclusion criteria in this trial
Exclusion criteria
Exclusion criteria: 1.pulmonary arterial hypertension (PAH)other than idiopathic or familial 2.For females, pregnancy or lactation 3.Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study 4.Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockerts, digoxin, diuretics 30 days prior tio randomization and during the study 5.Large shift in altitude (defined as greaterthan 5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit 6.Subjects with intracardiac shunts and/or serious heart, lung or other health conditions 7.HIV positive subjects 8.Subjects participating in another clinical trial with an investigational drug or device 9.Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy 10.Allergies and previous intolerance of PDE5 inhibitors 11.Alcohol or drug abuse 12.Blood donation during the study, or 1 month before or after the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in PVRITimepoint: Day 1, 4 hours post dose ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in PaO2 and PaCO2Timepoint: Day 1, up to 4 hours post dose;Greatest reduction and hourly changes from baseline in PVRITimepoint: Day 1, up to 4 hours post dose;Hourly changes from baseline in cardiac index, mean PAP and other hemodynamic parametersTimepoint: Day 1, up to 4 hours post dose;Mean change, greatest reduction and hourly changes from baseline in SVRITimepoint: Day 1, up to 4 hours post dose;Plasma concentrations of PF-00489791 and sildenafilTimepoint: up to Day 3 to 5;Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse eventsTimepoint: up to Day 10 - 14;Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events, changes from baseline in clinical laboratory tests, and ECGTimepoint: up to Day 3 - 5 | — |
Countries
Belgium, Canada, Germany, India, Peru, Russian Federation, Spain, Sweden, Switzerland, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed