Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH

Dong-A ST

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Udenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02304198

DA8159_PAH_EX

Details and patient eligibility

About

This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).

Full description

Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure.

Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Udenafil

Experimental group

Description:

Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)

Treatment:

Drug: Udenafil