essential hypertension MedDRA version: 12.0 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ALISKIREN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical Form: Tablet
INN or Pro
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients within the range age between 18 and 65 years, male and female, with a new diagnosis of mild-moderate essential hypertension and blood pressure values measured on sitting position (after 10 minutes of rest) between 140/90 mmHg and 179/109 mmHg, confirmed in at least 2 different measurements in a period of 1 month. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients younger than 18 years and older than 65 years; - Patients with secondary forms of hypertension - Smokers (> 5 cigarette/day) - Obese patients (body mass index > 30 Kg/m2) - Pregnant patients, or patients taking oral contraceptives - Patients with chronic infective diseases; - Patients with chronic renal diseases - Patients with liver diseases - Patients with lung or metabolic (diabetes mellitus, thyroid disorders) diseases - Patients with coronary artery disease or cerebral vascular diseases - Patients with hypercholesterolemia (plasma total cholesterol > 240 mg/dL) -Patients with autoimmune diseases - Patients with hematologic diseases or coagulation disorders - Patients who were assuming within previous 30 days drugs able to modify hepatic or renal metabolism or able to affect the function of other major organs, or drugs able to modify the systolic, diastolic blood pressure values or heart rate Patients with a new diagnosis of essential hypertension with blood pressure values, measured on sitting position (after 10 minutes of rest) higher than 180/100 mmHg, confirmed in at least 2 different measurements in a period of 1 month. - Patients with target organ damage secondary to hypertension - Patients not able to give a written consent to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of aliskiren on endothelial dysfunction, nitric oxide availability and reactive oxygen species production at the level of the forearm microcirculation in patient with essential hypertension.;Secondary Objective: Assessment of whether Aliskiren can improve the function enthodelial at the level of macrocirculation peripheral (brachial artery) and parameters of rigidity arterial.;Primary end point(s): Before and after treatment, it will be evaluated the percent modification of forearm blood flow induced by endothelial agonists and antagonists. Additionally, the percent of inhibition by L-NMMA on endothelium-dependent vasodilation will evaluate NO availability. Finally, the percent of potentiating effect by vitamin C on endothelial function will evaluate the oxidative stress production. | — |
Countries
Italy
Outcome results
None listed