Overview

Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
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 orally given to Japanese pulmonary arterial hypertension patients (Part 1)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Citric Acid
Sildenafil Citrate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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