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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304198
• Other study ID #: DA8159_PAH_EX
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 26, 2014
• Last updated: April 15, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Udenafil
Udenafil 50mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-Gu, Irwon-Dong 50

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)	Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc	during 48-weeks	Yes
Secondary	6-MWD		24, 48-week	No
Secondary	BORG dyspnea score		24, 48-week	No
Secondary	WHO class		12, 24, 36, 48-week	No
Secondary	Time to clinical worsening(TTCW)		during 48-weeks	No
Secondary	NT-pro BNP		24, 48-week	No
Secondary	Echocardiography		48-week	No