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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Pfizer decided to stop this trial early upon Stage 1 completion due to change in PF-00489791 development and not as a result of safety concerns for PF-00489791. Date of termination (LSLV) occurred on July 28, 2010.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Idiopathic or familial pulmonary arterial hypertension (PAH)
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
You may not be if
pulmonary arterial hypertension (PAH)other than idiopathic or familial
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
Clareo Health | 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