Status:
COMPLETED
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID...
Eligibility Criteria
Inclusion
- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
- Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
- Subjects whose baseline 6-Minute Walk test distance is \>100 m and \<450 m
Exclusion
- Significant Hepatic and/or renal disorder
- Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
- Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00454207
Start Date
April 1 2007
End Date
February 1 2009
Last Update
February 21 2021
Active Locations (8)
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1
Pfizer Investigational Site
Chiba, Chiba, Japan
2
Pfizer Investigational Site
Kanazawa, Ishikawa-ken, Japan
3
Pfizer Investigational Site
Tsu, Mie-ken, Japan
4
Pfizer Investigational Site
Okayama, Okayama-ken, Japan