NCT02304198

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

A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Udenafil	Udenafil 50mg tablet

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-12-01
• Last updated: 2016-04-18

Locations

1 site across 1 country: South Korea