23 completed, 7 unknown, 1 recruiting, 1 terminated. 17 Phase 3, 9 Phase 1, 8 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 12, Unknown 3, Recruiting 1, Terminated 1 |
| Phase 1 | 9 | Completed 7, Unknown 2 |
| Phase 2 | 8 | Completed 6, Unknown 1, Withdrawn 1 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
Follow udenafil: new trials by email Literature Review of udenafil trials Research Report on udenafil
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 Udenafil, Placebo - Single Ventricle Heart Disease | Phase 3 | Recruiting | Mezzion Pharma Co. Ltd | 436 | 2023-10-30 | 2025-10-28 |
| Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness Udenafil - Single Ventricle Heart Disease | Phase 3 | Completed | Mezzion Pharma Co. Ltd | 88 | 2018-02-20 | 2025-10-14 |
| A Extension Study of Udenafil in Adolescents Udenafil - Functional Single Ventricle Heart Disease | Phase 3 | Completed | Mezzion Pharma Co. Ltd | 301 | 2017-02-06 | 2025-12-09 |
| Fontan Udenafil Exercise Longitudinal Assessment Trial Udenafil, Placebo - Single Ventricle Heart Disease | Phase 3 | Completed | Mezzion Pharma Co. Ltd | 400 | 2016-07-22 | 2025-06-17 |
| Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Udenafil, Placebo - Erectile Dysfunction, Benign Prostatic Hyperplasia | Phase 2 | Withdrawn | Takeda | 2015-09-01 | 2016-03-04 | |
| Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents Udenafil - Single Ventricle Heart Disease After Fontan Surgery | Phase 1 / Phase 2 | Completed | Mezzion Pharma Co. Ltd | 36 | 2014-07-01 | 2025-05-06 |
| Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH Udenafil - Pulmonary Arterial Hypertension | Phase 2 / Phase 3 | Completed | Dong-A ST Co., Ltd. | 59 | 2014-04-01 | 2016-04-18 |
| Zydena on Cognitive Function of Alzheimer's Disease Patients Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg, Placebo + Donepezil 5mg or 10mg, Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg - Alzheimer's Disease | Phase 3 | Unknown | Samsung Medical Center | 210 | 2013-09-01 | 2013-09-12 |
| Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine Dapoxetine, Udenafil, Udenafil+Dapoxetine - Healthy Male Subjects | Phase 1 | Unknown | Dong-A Pharmaceutical Co., Ltd. | 24 | 2013-09-01 | 2013-08-26 |
| Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration Udenafil, Bosentan, Udenafil/Bosentan - Healthy Volunteers | Phase 1 | Unknown | Dong-A Pharmaceutical Co., Ltd. | 30 | 2013-08-01 | 2014-01-09 |
| Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults Udenafil, Placebo - Erectile Dysfunction, Phosphodiesterase 5 Inhibitor | Phase 1 | Completed | Takeda | 83 | 2013-07-01 | 2013-10-22 |
| A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF] Placebo, Udenafil (Zydena) - Diastolic Heart Failure | Phase 3 | Unknown | Seoul National University Hospital | 52 | 2012-10-01 | 2013-01-31 |
| A Randomized Trial of Udenafil Therapy in Patients With Mild Pulmonary Hypertension [ULTIMATE-Mild PHT] Placebo, Udenafil (Zydena) - Mild Pulmonary Hypertension | Phase 3 | Unknown | Seoul National University Hospital | 40 | 2012-09-01 | 2013-02-25 |
| Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure Placebo, Udenafil (Zydena) - Systolic Heart Failure | Phase 3 | Terminated | Seoul National University Hospital | 41 | 2011-12-01 | 2014-04-24 |
| Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image Udenafil, placebo - Microvascular Angina | Phase 4 | Unknown | Samsung Medical Center | 70 | 2011-12-01 | 2014-03-26 |
| Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity Zydena (Udenafil), Placebo - Vascular Dementia, Subcortical Vascular Dementia | Phase 2 | Unknown | Samsung Medical Center | 80 | 2011-11-01 | 2011-11-08 |
| Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction DA-8159 (Udenafil) - Erectile Dysfunction | Phase 3 | Completed | Dong-A Pharmaceutical Co., Ltd. | 302 | 2011-11-01 | 2013-07-17 |
| Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) udenafil, placebo - Pulmonary Arterial Hypertension | Phase 2 | Completed | Dong-A ST Co., Ltd. | 63 | 2011-08-01 | 2016-04-18 |
| Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction DA-8159 (Udenafil), Placebo - Erectile Dysfunction | Phase 3 | Completed | Dong-A Pharmaceutical Co., Ltd. | 349 | 2011-04-01 | 2013-01-24 |
| Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon Udenafil or Amlodipine - Raynaud Phenomenon | Phase 2 / Phase 3 | Completed | Seoul National University Hospital | 29 | 2011-01-01 | 2012-12-11 |
Showing 20 of 33. Sign in to see all of them.
Erectile Dysfunction (12) · Hypertension, Pulmonary (2) · Pulmonary Arterial Hypertension (2) · Rectal Neoplasms (2) · Alzheimer Disease (1) · Dementia, Vascular (1) · Dyspnea (1) · Heart Diseases (1) · Heart Failure, Diastolic (1) · Heart Failure, Systolic (1) · Ischemia (1) · Kidney Diseases (1) · Microvascular Angina (1) · Motor Activity (1) · Prostatic Hyperplasia (1)
Seoul National University Hospital (6) · Dong-A Pharmaceutical Co., Ltd. (5) · Mezzion Pharma Co. Ltd (5) · Warner Chilcott (4) · Samsung Medical Center (3) · Asan Medical Center (2) · Dong-A ST Co., Ltd. (2) · Takeda (2) · Abdi Ibrahim Ilac San. ve Tic A.S. (1) · Dong-A PharmTech Co., Ltd. (1) · Inje University (1) · Kyungpook National University Hospital (1)
South Korea (20) · United States (10) · Canada (4) · Mexico (2) · Turkey (Türkiye) (1)
Herman Ellman, MD (4) · Kyun-Seop Bae, M.D., Ph.D. (3) · D G Moon, MD, PhD (2) · D Y Yang, MD, PhD (2) · Goo-Yeong Cho, MD, PhD (2) · Hyung-Kwan Kim, MD, PhD (2) · In-Chang Hwang, MD (2) · J J Kim, MD, PhD (2) · J K Park, MD, PhD (2) · J S Paick, MD, PhD (2) · K H Moon, MD, PhD (2) · K S Min, MD, PhD (2) · Kyung-Hee Kim, MD (2) · N C Park, MD, PhD (2)
PMID 29910047, PMID 22946546, PMID 23799908, PMID 24352340, PMID 25154607, PMID 25482466, PMID 30808080, PMID 31202506, PMID 31736357, PMID 36378780
U01HL068270 (4)