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Completed

NCT Number: NCT02304198

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

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).

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Samsung Medical Center

Seoul, Gangnam-Gu, Irwon-Dong 50, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Udenafil

Drug

Udenafil 50mg tablet

Other names: Zydena

Primary outcomes

  1. Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)

    Time frame: during 48-weeks

    Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc

Secondary outcomes

  1. 6-MWD

    Time frame: 24, 48-week

  2. BORG dyspnea score

    Time frame: 24, 48-week

  3. WHO class

    Time frame: 12, 24, 36, 48-week

  4. Time to clinical worsening(TTCW)

    Time frame: during 48-weeks

  5. NT-pro BNP

    Time frame: 24, 48-week

  6. Echocardiography

    Time frame: 48-week

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2014
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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