Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Viatris

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: sildenafil citrate (UK-92,480)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454207

A1481252

JapicCTI-070381

Details and patient eligibility

About

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)

Enrollment: 44 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

sildenafil citrate (UK-92,480)

Experimental group

Description:

sildenafil citrate 20 mg TID

Treatment:

Drug: sildenafil citrate (UK-92,480)