E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ARTERIAL HYPERTENSION |
IPERTENSIONE ARTERIOSA |
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E.1.1.1 | Medical condition in easily understood language |
ARTERIAL HYPERTENSION |
IPERTENSIONE ARTERIOSA |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020775 |
E.1.2 | Term | Hypertension arterial |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study aims to analyze the time-dependent activity of N-acetylcysteine (oral vs i.v. administration comparison) on the levels of Cys-HSA and on the plasma antioxidant capacity in subjects with redox unbalance. |
Questo studio si propone di analizzare se la somministrazione di NAC per via orale o endovenosa influenza i livelli circolanti di Cys-HSA e ripristina l’attività antiossidante del plasma. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent according to federal, local, and institutional guidelines before the first study-specific procedure - Aware of the risks involved in the study and able to understand and comply with the study procedures - Male or female at least 18 years old at screening - Body weight greater than 45 kg at screening. - Altered redox balance assayed by plasma assay due to hypertension (according to the current guidelines for high blood pressure of the American Heart Association (AHA) and the American College of Cardiology :130/80 mm Hg). If the subject is a woman: - She must be negative to hCG pregnancy test - Fertile women will be required to take effective contraceptive measures during the study drug intake period, must use an adequate contraceptive method or have to be surgically sterile |
- Fornire un consenso informato scritto secondo le linee guida federali, locali e istituzionali prima del primo studio -procedura specifica - Comprendere i rischi connessi allo studio - Essere in grado di comprendere e rispettare le procedure di studio - Avere almeno 18 anni allo screening - Peso corporeo superiore a 45 kg allo screening - Alterazione del bilancio redox, causata dell'ipertensione, dosata mediante analisi del plasma (secondo le linee guida attuali per la pressione alta dell'American Heart Association (AHA) e dell'American College of Cardiology: 130 / 80 mm Hg). Se il soggetto è donna: - Test gravidanza hCG negativo - E' necessario usare un metodo contraccettivo adeguato o devono essere chirurgicamente sterili. |
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E.4 | Principal exclusion criteria |
- severe obstructive and/or restrictive lung disease - anemia (hemoglobin,11 g/dL) - history and/or documentation of pulmonary embolism - primary valvular heart disease - pulmonary arterial hypertension - pericardial disease - exercise-induced angina - ST changes - severe arrhythmias - significant cerebrovascular, renal, hepatic and hematological disease - hypersensitivity to the active substance or to any of the excipients - administration of an experimental drug within 30 days or 5 half-lives of the investigational drug - fertile women who do not use highly effective methods of contraception - pregnancy - any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) - History of clinically significant malignant disease - unable to comply with the study requirements, including the number of required visits to the clinical site - history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. |
- Gravi malattie polmonari ostruttive e / o restrittive, - Anemia (emoglobina, 11 g / dL), - Storia e / o documentazione di embolia polmonare - Cardiopatia valvolare primaria - Ipertensione arteriosa polmonare - Malattia pericardica - Angina indotta da esercizio fisico - Cambiamenti di ST - Aritmie gravi e significative patologie cerebrovascolari, renali, epatiche ed ematologiche. - Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti - Somministrazione di un farmaco sperimentale entro 30 giorni o 5 emivite del farmaco sperimentale, - Donne fertili che non usano metodi contraccettivi altamente efficaci, gravidanza, - Qualsiasi condizione comorbosa acuta o grave (p. es., infezione grave o disfunzione ematologica, renale, metabolica, gastrointestinale o endocrina); - Storia di malattia maligna clinicamente significativa; - Incapacità di soddisfare i requisiti dello studio, incluso il numero di visite richieste in ospedale; - Storia clinica o evidenza di qualsiasi altro disturbo, condizione o malattia clinicamente significativa che, secondo l'opinione dello sperimentatore, costituirebbe un rischio per la sicurezza dei partecipanti o interferire con la valutazione, le procedure o il completamento dello studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the efficacy of NAC treatment on the levels of cistenylated albumin, a parameter of oxidative stress, measured by mass spectrometry, in patients with heart failure comparing the two groups (NAC vs placebo). |
Valutazione dell’efficacia del trattamento con NAC sui livelli di albumina cistenilata, un parametro di stress ossidativo, misurata mediante spettrometria di massa, in pazienti con ipertensione confrontando i due gruppi (NAC vs placebo). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pre and post administration oper os and iv |
Pre e post somministrazione della dose singola per os e ev |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |