ARTERIAL HYPERTENSION MedDRA version: 21.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Interventions
Trade Name: ACETILCISTEINA EG - 300 MG/3 ML SOLUZIONE INIETTABILE E DA NEBULIZZARE 5 FIALE
Product Name: ACETILCISTEINA - 300 MG/3 ML SOLUZIONE INIETTABILE E PER NEBULIZZATORE E PER ISTILLAZIONE ENDOT
Sponsors
CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: NA;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).;Timepoint(s) of evaluation of this end point: Pre and post administration oper os and iv | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici ed Attività R
Istituto Europeo di Oncologia
Outcome results
None listed