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

A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553721

Enrollment

Registered

2012-03-14

Start date

2011-08-31

Completion date

2015-03-31

Last updated

2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief 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).

Interventions

DRUGudenafil

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

DRUGplacebo

Phase IIa - placebo Phase IIb - placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Phase IIa - Pulmonary vascular resistance index(PVRI)	4 hours
Phase IIb - 6-minute walk distance	16weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026