Pulmonary Arterial Hypertension
Conditions
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.
Interventions
DRUGUdenafil
Udenafil 50mg tablet
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who completed the initial study(DA8159\_PAH\_II), 12-week, double-blind, placebo-controlled trial
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| BORG dyspnea score | 24, 48-week |
| WHO class | 12, 24, 36, 48-week |
| 6-MWD | 24, 48-week |
| NT-pro BNP | 24, 48-week |
| Echocardiography | 48-week |
| Time to clinical worsening(TTCW) | during 48-weeks |
Countries
South Korea
Outcome results
None listed