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The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).
A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".
FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.
Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDY-5301 Low Dose | Experimental | Anticipated n=20 |
|
| FDY-5301 Intermediate Dose | Experimental | Anticipated n=20 |
|
| FDY-5301 High Dose | Experimental | Anticipated n=20 |
|
| Placebo | Placebo Comparator | Anticipated n=20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDY-5301 | Drug | FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day. |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmias of Interest, 48 Hours (Overall) | Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment. | First 48 hours post-treatment |
| Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group | 48 hours post-treatment |
| Arrhythmias of Interest, 14 Days (Overall) | Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment. | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) |
| Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment | 72 hours post-treatment |
| Infarct Size Relative to Ventricular Volume, 3 Months (Overall) |
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Inclusion Criteria:
Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55047 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34774885 | Derived | Adlam D, Zarebinski M, Uren NG, Ptaszynski P, Oldroyd KG, Munir S, Zaman A, Contractor H, Kiss RG, Edes I, Szachniewicz J, Nagy GG, Garcia MJ, Tomcsanyi J, Irving J, Sharp ASP, Musialek P, Lupkovics G, Shirodaria C, Selvanayagam JB, Quinn P, Ng L, Roth M, Insko MA, Haber B, Hill S, Siegel L, Tulloch S, Channon KM. A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI. Int J Cardiol. 2022 Jan 15;347:1-7. doi: 10.1016/j.ijcard.2021.11.016. Epub 2021 Nov 12. |
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A total of 120 subjects were randomized 3:1 to receive one of three dosage amounts of study drug or placebo.
The first participant enrolled on October 27, 2017 in study centers in Poland, Hungary, UK, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental FDY-5301 Low Dose | 0.5 mg/kg FDY-5301 |
| FG001 | Experimental FDY-5301 Intermediate Dose | 1.0 mg/kg FDY-5301 |
| 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 | Yes | No | No | Study Protocol | May 21, 2018 | Oct 7, 2021 |
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All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
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This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
| Placebo | Other | Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day. |
|
|
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
| 3 months post-treatment |
| Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment) | 72 hours post-treatment |
| Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment) | 3 months post-treatment |
| Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment | 72 hours post-treatment |
| Left Ventricular End Systolic Volume Index, 3 Months (Overall) | Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment | 3 months post-treatment |
| Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment | 72 hours post-treatment |
| Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment | 3 months post-treatment |
| Left Ventricular Ejection Fraction, 72 Hours (Overall) | Left ventricular ejection fraction at 72 hours post-treatment | 72 hours post-treatment |
| Left Ventricular Ejection Fraction, 3 Months (Overall) | Left Ventricular Ejection Fraction at 3 Months (Overall) | 3 months post-treatment |
| Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | Left ventricular ejection fraction at 72 hours post-treatment | 72 hours post-treatment |
| Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts) | 3 months post-treatment |
| Serum Troponin Concentrations, 48 Hours (Overall) | Area under the curve of serum troponins measured over 48 hours post-treatment | 48 hours post-treatment |
| Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | Area under the curve of serum troponins measured over 48 hours post-treatment | 48 hours post-treatment |
| ST-segment Resolution | Proportion of patients with ST-segment resolution at 4 hours post-dose | 4 hours post-dose |
| The Bronx |
| New York |
| 10467 |
| United States |
| Budai Irgalmasrendi Kórház | Budapest | Hungary |
| Magyar Honvédség Egészségügyi Központ | Budapest | Hungary |
| Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika | Debrecen | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház | Miskolc | Hungary |
| Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Hungary |
| Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii | Katowice | Silesian Voivodeship | Poland |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej | Grodzisk Mazowiecki | Poland |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej | Krakow | Poland |
| Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz | Poland |
| Miedziowe Centrum Zdrowia | Lubin | Poland |
| Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw | Poland |
| KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny | Wroclaw | Poland |
| Royal Devon and Exeter Hospital Cardiology Department | Exeter | Devon | United Kingdom |
| Wythenshawe Hospital | Manchester | Greater Manchester | United Kingdom |
| Glenfield Hospital | Leicester | Leicestershire | United Kingdom |
| University of Oxford | Oxford | Oxfordshire | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | Tyne and Wear | United Kingdom |
| New Cross Hospital | Wolverhampton | West Midlands | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | United Kingdom |
| FG002 | Experimental FDY-5301 High Dose | 2.0 mg/kg FDY-5301 |
| FG003 | Placebo | Placebo |
| COMPLETED |
|
| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental FDY-5301 Low Dose | 0.5 mg/kg FDY-5301 |
| BG001 | Experimental FDY-5301 Intermediate Dose | 1.0 mg/kg FDY-5301 |
| BG002 | Experimental FDY-5301 High Dose | 2.0 mg/kg FDY-5301 |
| BG003 | Placebo | Placebo |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Arrhythmias of Interest, 48 Hours (Overall) | Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment. | Posted | Number | participants | First 48 hours post-treatment |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group | Posted | Number | Percentage | 48 hours post-treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Arrhythmias of Interest, 14 Days (Overall) | Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment. | Posted | Number | participants | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group | Posted | Number | Percentage | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment | Posted | Median | Full Range | INF/VV (%) | 72 hours post-treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment) | Posted | Median | Full Range | INF/VV (%) | 3 months post-treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment) | Posted | Median | Full Range | INF/VV (%) | 72 hours post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment) | Posted | Median | Full Range | INF/VV (%) | 3 months post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment | Posted | Median | Full Range | mL/kg/M2 | 72 hours post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment | Posted | Median | Full Range | mL/kg/M2 | 3 months post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment | Posted | Median | Full Range | mL/kg/M2 | 72 hours post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment | Posted | Median | Full Range | mL/kg/M2 | 3 months post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Ejection Fraction, 72 Hours (Overall) | Left ventricular ejection fraction at 72 hours post-treatment | Posted | Median | Full Range | Percentage | 72 hours post-treatment |
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| Secondary | Left Ventricular Ejection Fraction, 3 Months (Overall) | Left Ventricular Ejection Fraction at 3 Months (Overall) | Posted | Median | Full Range | Percentage | 3 months post-treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | Left ventricular ejection fraction at 72 hours post-treatment | Posted | Median | Full Range | Percentage | 72 hours post-treatment |
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| Secondary | Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts) | Posted | Median | Full Range | Percentage | 3 months post-treatment |
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| Secondary | Serum Troponin Concentrations, 48 Hours (Overall) | Area under the curve of serum troponins measured over 48 hours post-treatment | Posted | Median | Full Range | AUC4-48 µg/L | 48 hours post-treatment |
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| Secondary | Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | Area under the curve of serum troponins measured over 48 hours post-treatment | Posted | Median | Full Range | AUC4-48 µg/L | 48 hours post-treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ST-segment Resolution | Proportion of patients with ST-segment resolution at 4 hours post-dose | Posted | Number | percentage | 4 hours post-dose |
|
|
Day 1 to 3 months
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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 | Experimental FDY-5301 Low Dose | 0.5 mg/kg FDY-5301 | 0 | 29 | 7 | 29 | 9 | 29 |
| EG001 | Experimental FDY-5301 Intermediate Dose | 1.0 mg/kg FDY-5301 | 1 | 31 | 7 | 31 | 4 | 31 |
| EG002 | Experimental FDY-5301 High Dose | 2.0 mg/kg FDY-5301 | 1 | 31 | 4 | 31 | 9 | 31 |
| EG003 | Placebo | Placebo | 1 | 29 | 8 | 29 | 18 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
We have multiple agreements (through our CRO) with multiple PIs in various countries. The most restrictive of those agreements prohibits the PI from publicly disclosing any study results without our (or our CRO's) prior written permission to do so.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Faraday Pharmaceuticals, Inc | 206-492-5310 | info@faradaypharma.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2018 | Oct 7, 2021 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Poland |
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| United Kingdom |
|
| Sustained Ventricular Tachycardia |
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| Non-Sustained Ventricular Tachycardia |
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| High-Degree AV Block |
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| Atrial Fibrillation |
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