A Phase 3 interventional study of Placebo and Udenafil (Zydena) in Mild Pulmonary Hypertension, sponsored by Seoul National University Hospital. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5 inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with mild pulmonary hypertension.
Pulmonary arterial hypertension is a devastating progressive disease increasingly debilitating symptoms. In the past few years, treatment of pulmonary hypertension has undergone an extraordinary evolution. A selective PDE-5 inhibitor, Sildenafil, has been shown to be as an effective pulmonary vasodilator as inhaled NO in patients with primary pulmonary hypertension and has recently been shown to improve exercise capacity, resting hemodynamics, and WHO functional class in patients with pulmonary hypertension. However, to date, the effect of Sildenafil have been mainly studied in patients with advanced disease.
Udenafil (Zydena), a newly developed PDE-5 inhibitor, has been proved to have similar efficacy and safety profile, compared with other PDE-5 inhibitors. However, to date, the effect of Udenafil in mild pulmonary HT has never been evaluated. Therefore, we hypothesized that Udenafil, a newly developed phosphodiesterase type 5 inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with mild pulmonary hypertension.
In this 12-week, randomized, double-blind, placebo-controlled trial, patients with mild pulmonary hypertension will be enrolled according to the eligibility criteria. After randomization, study participants will be assigned to receive either 50mg of Udenafil or placebo two times a day for 4 weeks, and then the dosage will be doubled to 100mg two times a day for next 8 weeks. Participants will attend study visits at baseline and weeks 4 and 12. Physical examination, medical history review, blood sample collection and electrocardiogram will be conducted on each study visits. At baseline and week 12, participants will undergo cardiopulmonary exercise test and exercise echocardiography. At every study visits, researchers will collect health information.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capsule that is identically appearing with udenafil will be administered to patients in placebo group. For the first 4 weeks, patients will receive 50 mg of placebo drug two times a day, and then the dosage will be doubled to 100 mg two times a day for next 8 weeks.
Drug: Placebo
Patients will receive 50 mg of udenafil two times a day, and then the dosage will be doubled to 100 mg two times a day for next 8 weeks.
Drug: Udenafil (Zydena)
Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company. Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
Also known as: The same placebo drug of NCT01553721.
Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
Also known as: DA-8159 (CAS No 268203-93-6)
Change of maximal VO2 in cardiopulmonary exercise test
Comparison between groups and within groups.
Time frame: Baseline and 12th weeks
Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
Comparison between groups and within groups.
Time frame: Baseline, 4th week, and 12th week
Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of left ventricular systolic function expressed as ejection fraction (EF), fractional shortening (FS) in echocardiography
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of plasma concentration of BNP
Comparison between groups and within groups.
Time frame: Baseline, 4th week, and 12th week
All-cause death
The occurrence of all-cause mortality during 12 week follow-up
Time frame: 12th week
Cardiac death
The occurrence of cardiac death including sudden cardiac death during 12 week follow-up
Time frame: 12th week
Admission for heart failure
Admission due to congestive heart failure during 12 week follow-up
Time frame: 12th week
Composite clinical endpoints
Composite clinical endpoints during 12 week follow-up, are defined as follows: Composite of all-cause death and admission for heart failure Composite of cardiac death and admission for heart failure
Time frame: 12th week
Safety endpoint
Safety endpoint during 12 week follow-up, is defined as follows: Development of facial flushing, febrile sensation, eyeball pain, visual disturbance, headache, penile erection. Intolerance or development of other adverse drug reactions related with study drug.
Time frame: 12th week
This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital