Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
- Registration Number
- NCT02304198
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Udenafil Udenafil Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
- Primary Outcome Measures
Name Time Method Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc) during 48-weeks Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
- Secondary Outcome Measures
Name Time Method Echocardiography 48-week Time to clinical worsening(TTCW) during 48-weeks 6-MWD 24, 48-week NT-pro BNP 24, 48-week BORG dyspnea score 24, 48-week WHO class 12, 24, 36, 48-week
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of