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

Dong-A ST Co., Ltd.63 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

udenafilDRUG

Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)

placeboDRUG

Phase IIa - placebo Phase IIb - placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (9)

Seoul National University Hospital

Seoul, Chongno-gu, 28 Yongon-dong, South Korea

Samsung Medical Center

Seoul, Gangnam-Gu, Irwon-Dong 50, South Korea

Severance Hospital, Yonsei University Health System

Special City of Seoul, Seodaemungu, 250 Seonsanno, South Korea

Outcomes

Primary Outcomes

Phase IIa - Pulmonary vascular resistance index(PVRI)

Time frame: 4 hours

Phase IIb - 6-minute walk distance

Time frame: 16weeks

Data from ClinicalTrials.gov

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