Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00853112
Start Date
April 1 2009
End Date
July 1 2010
Last Update
October 24 2017
Active Locations (25)
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1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
2
John C. Lincoln Hospital, North Mountain
Phoenix, Arizona, United States, 85020
3
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85020
4
Shands at University of Florida
Gainesville, Florida, United States, 32610