Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
- Registration Number
- NCT01553721
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
• 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo 1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo udenafil udenafil 1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil
- Primary Outcome Measures
Name Time Method Phase IIb - 6-minute walk distance 16weeks Phase IIa - Pulmonary vascular resistance index(PVRI) 4 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Pusan national University Hospital
🇰🇷Pusan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwang-ju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Chongno-gu, 28 Yongon-dong, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Special City of Seoul, Seodaemungu, 250 Seonsanno, Korea, Republic of
Chungbook national University Hospital
🇰🇷Chung-ju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The catholic univ. of korea Seoul ST. MARY's hospital
🇰🇷Seoul, Korea, Republic of