Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Udenafil

Criteria

Inclusion Criteria:

• Subjects aged 18 and over who have any of the following diseases

• primary Pulmonary Arterial Hypertension

• secondary Pulmonary Arterial Hypertension caused by connective tissue disease

• [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion Criteria:

• Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria

• BMI(Body Mass Index) < 18.5kg/m2

• Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg)

• Creatinine clearance ≤ 30mL/min

• History of non-arteritic anterior ischemic optic neuropathy(NAION)