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 |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/26/2017 |
Start Date: | April 2009 |
End Date: | July 2010 |
A Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial Hypertension
Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
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.
development and not as a result of safety concerns for PF-00489791. Date of termination
(LSLV) occurred on July 28, 2010.
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
We found this trial at
8
sites
5323 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, Texas 75390
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Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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