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

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: udenafil; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01553721

DA8159_PAH_II

Details and patient eligibility

About

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).

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

udenafil

Experimental group

Description:

1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil

Treatment:

Drug: udenafil

placebo

Placebo Comparator group

Description:

1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo

Treatment:

Drug: placebo