Udenafil (DrugBank: Udenafil)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 86 | Pulmonary arterial hypertension | 2 |
| 210 | Single Ventricle | 4 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02304198 (ClinicalTrials.gov) | April 2014 | 26/11/2014 | Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH | A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: Udenafil | Dong-A ST Co., Ltd. | NULL | Completed | 18 Years | N/A | Both | 59 | Phase 2;Phase 3 | Korea, Republic of |
| 2 | NCT01553721 (ClinicalTrials.gov) | August 2011 | 1/1/2012 | Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: udenafil;Drug: placebo | Dong-A ST Co., Ltd. | NULL | Completed | 18 Years | N/A | Both | 63 | Phase 2 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03430583 (ClinicalTrials.gov) | February 20, 2018 | 22/1/2018 | Evaluation of Fontan-Associated Liver Disease | Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study | Single Ventricle Heart Disease | Drug: MZ101 | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 12 Years | N/A | All | 100 | United States;Canada | |
| 2 | NCT03013751 (ClinicalTrials.gov) | January 2017 | 5/1/2017 | A Extension Study of Udenafil in Adolescents | A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation | Functional Single Ventricle Heart Disease | Drug: Udenafil | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 12 Years | 18 Years | All | 300 | Phase 3 | United States;Canada;Korea, Republic of |
| 3 | NCT02741115 (ClinicalTrials.gov) | July 22, 2016 | 10/4/2016 | Fontan Udenafil Exercise Longitudinal Assessment Trial | Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL) | Single Ventricle Heart Disease | Drug: Udenafil;Drug: Placebo | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | 18 Years | All | 400 | Phase 3 | United States;Canada;Korea, Republic of |
| 4 | NCT02201342 (ClinicalTrials.gov) | July 2014 | 24/7/2014 | Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents | A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation | Single Ventricle Heart Disease After Fontan Surgery | Drug: Udenafil | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network;National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network | Completed | 14 Years | 18 Years | Both | 36 | Phase 1;Phase 2 | United States;Canada |