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

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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