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 - NCT00853112-92663 (Clinical Trial 347494)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy347494.aspx
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| City: |
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Newport Beach |
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State:
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CA |
| Zip Code: |
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92663 |
| Conditions: |
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Hypertension, Pulmonary |
| Purpose: |
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Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Pfizer Investigational Site
Newport Beach, CA 92663
United States
Primary Contact:
Pfizer CT.gov Call Center
Phone: 1-800-718-1021 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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