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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL068270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
This will be an open-label extension study. All enrolled subjects will be provided with udenafil for the duration of the study. Subjects completing the Phase III FUEL study will be eligible for recruitment. Additional subjects will be recruited as needed to ensure a minimum of 300 total subjects enroll. Safety, pharmacodynamic and quality of life data will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | Udenafil administered for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Active drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | Summary of Treatment Emergent Adverse Events | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal VO2 | Change in Maximal VO2 from baseline to 52 weeks | 52 Weeks |
| Change in Log-transformed Reactive Hyperemia Index (lnRHI) | Change from baseline to 52 weeks in Log-transformed Reactive Hyperemia Index (lnRHI). The Reactive Hyperemia Index (RHI) is the ratio of the amount of blood flow after the release of a period of vessel occlusion relative to baseline amount of blood flow. Because the amount of blood does not decrease after release of vessel occlusion, the minimum value for the RHI is 1.0, which would indicate no change in blood flow. There is no upper limit for this ratio, and higher values are generally thought to represent a healthier endothelial response. In this study, as in other studies, we used the natural log of RHI (lnRHI) to normalize the data. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Paridon, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29910047 | Derived | Goldberg DJ, Zak V, Goldstein BH, McCrindle BW, Menon SC, Schumacher KR, Payne RM, Rhodes J, McHugh KE, Penny DJ, Trachtenberg F, Hamstra MS, Richmond ME, Frommelt PC, Files MD, Yeager JL, Pemberton VL, Stylianou MP, Pearson GD, Paridon SM; Pediatric Heart Network Investigators. Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial. Am Heart J. 2018 Jul;201:1-8. doi: 10.1016/j.ahj.2018.03.015. Epub 2018 Apr 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | In PHN-Udenafil-02 (FUEL) Received Udenafil | Participants in this study arm had received Udenafil in PHN-Udenafil-02 study. |
| FG001 | In PHN-Udenafil-02 (FUEL) Received Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2020 |
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| 52 Weeks |
| Change in Serum BNP | Change in Serum BNP from baseline to 52 weeks | 52 Weeks |
| Change in Myocardial Performance Index (MPI) | Change in Myocardial Performance Index from baseline to 52 weeks | 52 Weeks |
| Change in PedsQL Physical Functioning (Child Reported) | Change in PedsQL Physical Functioning (Child Reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | 52 Weeks |
| Change in PedsQL Physical Functioning (Parent Reported) | Change in PedsQL Physical Functioning (Parent Reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | 52 Weeks |
| Change in PedsQL Psychosocial Health Summary Score (Child Reported) | Change in PedsQL Psychosocial Health Summary Score (Child reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | 52 Weeks |
| Change in PedsQL Psychosocial Health Summary Score (Parent Reported) | Change in PedsQL Psychosocial Health Summary Score (Parent reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | 52 Weeks |
| Change in PedsQL Functional Health Status Score (Child Reported) | Change in PedsQL Functional Health Status Score (Child reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | 52 Weeks |
| Change in PedsQL Functional Health Status Score (Parent Reported) | Change in PedsQL Functional Health Status Score (Parent reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | 52 Weeks |
| Cedars/Sinai Heart Institute |
| Los Angeles |
| California |
| 90048 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Nemours Cardiac Center/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20008 | United States |
| Johns Hopkins All Children's Heart Institute | St. Petersburg | Florida | 33701 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Riley Hospital for Children/Herman B. Wells Center for Pediatric Research | Indianapolis | Indiana | 46201 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109-4204 | United States |
| Children's Mercy Hospital Kansas City | Kansas City | Missouri | 64108 | United States |
| Washington University St. Louis/St.Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital of New York | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Medical Hospital/Dept. of Pediatric Cardiology | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hosptial | Seattle | Washington | 98105 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| The Hospital for Sick Children | Toronto | Ontario | ON M5G 1X8 | Canada |
| Sejong General Hospital | Bucheon-si | Gyeonggi-do | 14754 | South Korea |
| Seoul National University Children's Hospital | Seoul | 110-744 | South Korea |
Participants in this study arm had received Placebo in PHN-Udenafil-02 study.
| FG002 | De novo | Did not participate in PHN-Udenafil-02 study. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In PHN-Udenafil-02 (FUEL) Received Udenafil | Participants in this study arm had received Udenafil in PHN-Udenafil-02 study. |
| BG001 | In PHN-Udenafil-02 (FUEL) Received Placebo | Participants in this study arm had received Placebo in PHN-Udenafil-02 study. |
| BG002 | De Novo | Did not participate in PHN-Udenafil-02 study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 12 to 18 years old | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| ||||||||||
| Height | Mean | Standard Deviation | centimeter |
| ||||||||||
| Maximal VO2 | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). VO2 has been presented in mL/min (i.e., not adjusted for body weight). | Mean | Standard Deviation | mL/min |
| |||||||||
| Myocardial Performance Index (MPI) | The MPI is a measure of systolic and diastolic function determined by velocities from blood pool Doppler assessment of the inflow and outflow tract of the dominant ventricle. MPI is calculated by dividing the sum of the isovolumetric contraction and relaxation time by the ejection time at each site measurement. The MPI is used to measure global cardiac dysfunction; decreases in MPI correspond with improved cardiac function and increases in MPI correspond with diminished cardiac function. The mean MPI in healthy people without heart disease is approximately 0.35. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | Ratio |
| ||||||||
| Log-transformed Reactive Hyperemia Index (lnRHI) | The Reactive Hyperemia Index (RHI) is the ratio of the amount of blood flow after the release of a period of vessel occlusion relative to baseline amount of blood flow. Because the amount of blood does not decrease after release of vessel occlusion, the minimum value for the RHI is 1.0, which would indicate no change in blood flow. There is no upper limit for this ratio, and higher values are generally thought to represent a healthier endothelial response. In this study, as in other studies, we used the natural log of RHI (lnRHI) to normalize the data. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | Natural log-transformed RHI (lnRHI) |
| ||||||||
| Serum BNP | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | pg/mL |
| |||||||||
| Pediatric Quality of Life (PedsQL)-Physical Functioning-Child reported | The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
| ||||||||
| Pediatric Quality of Life (PedsQL)-Physical Functioning-Parent reported | The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
| ||||||||
| Pediatric Quality of Life (PedsQL)-Psychosocial Health Summary Score-Child reported | The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
| ||||||||
| Pediatric Quality of Life (PedsQL)-Psychosocial Health Summary Score-Parent reported | The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
| ||||||||
| Pediatric Quality of Life (PedsQL)-Functional Health Status Score-Child reported | The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
| ||||||||
| Pediatric Quality of Life (PedsQL)-Functional Health Status Score-Parent reported | The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | Baseline results only presented for subjects who have data at 52 weeks (i.e., paired-data points). | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-Emergent Adverse Events | Summary of Treatment Emergent Adverse Events | Safety Population | Posted | Count of Participants | Participants | 52 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Maximal VO2 | Change in Maximal VO2 from baseline to 52 weeks | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). VO2 has been presented in mL/min (i.e., not adjusted for body weight). | Posted | Mean | Standard Deviation | mL/min | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Log-transformed Reactive Hyperemia Index (lnRHI) | Change from baseline to 52 weeks in Log-transformed Reactive Hyperemia Index (lnRHI). The Reactive Hyperemia Index (RHI) is the ratio of the amount of blood flow after the release of a period of vessel occlusion relative to baseline amount of blood flow. Because the amount of blood does not decrease after release of vessel occlusion, the minimum value for the RHI is 1.0, which would indicate no change in blood flow. There is no upper limit for this ratio, and higher values are generally thought to represent a healthier endothelial response. In this study, as in other studies, we used the natural log of RHI (lnRHI) to normalize the data. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | Natural log-transformed RHI (lnRHI) | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Serum BNP | Change in Serum BNP from baseline to 52 weeks | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). The de novo population did not have any paired-data. | Posted | Mean | Standard Deviation | pg/mL | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Myocardial Performance Index (MPI) | Change in Myocardial Performance Index from baseline to 52 weeks | Efficacy population | Posted | Mean | Standard Deviation | mL/min | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Physical Functioning (Child Reported) | Change in PedsQL Physical Functioning (Child Reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Physical Functioning (Parent Reported) | Change in PedsQL Physical Functioning (Parent Reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Physical Function Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported physical function. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Psychosocial Health Summary Score (Child Reported) | Change in PedsQL Psychosocial Health Summary Score (Child reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Psychosocial Health Summary Score (Parent Reported) | Change in PedsQL Psychosocial Health Summary Score (Parent reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Psychosocial Health Summary Scale is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better reported psychosocial health. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Functional Health Status Score (Child Reported) | Change in PedsQL Functional Health Status Score (Child reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from a child's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in PedsQL Functional Health Status Score (Parent Reported) | Change in PedsQL Functional Health Status Score (Parent reported) from baseline to 52 weeks. The Pediatric Quality of Life Inventory (PedsQL) - Functional Health Status Score is calculated from parent's answers to a short questionnaire. The range of possible scores is 0-100, and higher scores indicate better functional health status. | Results presented only for subjects who have data at baseline and 52 weeks (i.e., paired-data points). | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
|
52 Weeks
Subjects taking the study drug for 52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total | Total number of subjects who participated in the open-label extension study (PHN-Udenafil-03) | 0 | 301 | 54 | 301 | 257 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Protein-losing gastroenteropathy | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tooth Impacted | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac cirrhosis | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Congestive hepatopathy | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Burkitt's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA (28.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Intentional self injury | Psychiatric disorders | MedDRA (28.0)MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pulmonary artery stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Angioplasty | Surgical and medical procedures | MedDRA (28.0) | Systematic Assessment |
| |
| Scoliosis surgery | Surgical and medical procedures | MedDRA (28.0) | Systematic Assessment |
| |
| Tympanoplasty | Surgical and medical procedures | MedDRA (28.0) | Systematic Assessment |
| |
| Hyptension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operatons | Mezzion Pharmaceuticals, Inc | 3128980292 | wg.kim@mezzion.com |
| Type | Description | Creation Date | Issued Date | Release Date | Posted Date |
|---|---|---|---|---|---|
| Issues in letter addressed; confirmed by FDA. | The responsible party has responded, and this matter was resolved administratively. | Feb 6, 2026 | Jan 28, 2026 | Nov 25, 2025 | Feb 9, 2026 |
| Violation Identified by FDA | Failure to Submit. The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry. | Apr 14, 2025 | Mar 14, 2025 | Nov 22, 2020 | Apr 15, 2025 |
| Sep 30, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C419664 | udenafil |
Not provided
Not provided
Not provided
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| Subjects with one or more SAEs |
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| Subjects with one or more drug-related SAEs |
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| Subjects who temporarily stopped study drug for one or more TEAEs |
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| Subjects who permanently discontinued study drug for one or more TEAEs |
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Subjects who did not participate in the FUEL trial but joined the open-label trial de novo and received 52 weeks of udenafil. |
| OG003 | Total | Total number of subjects who participated in the open-label extension study |
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| Units | Counts |
|---|---|
| Participants |
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| Total |
Total number of subjects who participated in the open-label extension study |
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| Total |
Total number of subjects who participated in the open-label extension study |
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| Total |
Total number of subjects who participated in the open-label extension study |
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| OG003 |
| Total |
Total number of subjects who participated in the open-label extension study |
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| Total |
Total number of subjects who participated in the open-label extension study |
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| Total |
Total number of subjects who participated in the open-label extension study |
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