Hypertension MedDRA version: 19.0 Level: PT Classification code 10051753 Term: Vascular calcification System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: PERINDOPRIL DOC GENERICI - 4 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC/PVAC-AL
Product Name: Perindopril
Pharmaceutical Form: Tablet
Trade Name: ESIDREX - 25 MG COMPRESSE 20 COMPRESSE
Pro
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged between 25 and 60 years with newly diagnosed mild to moderate essential hypertension ( systolic blood pressure between 140 and 160 mmHg and diastolic blood pressure between 90 and 110 mmHg measured as the average of three consecutive measurements ) 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known causes of secondary hypertension ; - Pregnant women , nursing mothers or women of childbearing age taking anti - contraceptives ; - Severe hypertension or malignant ; - History of kidney disease ; - Significant renal disease ( creatinine clearance less than 60 ml / min ) ; anuria . - Hypokalemia or hyponatremia refractory ; - Hypercalcemia ; -iperuricemia symptomatic ; - Liver disease ; - Heart disease ( myocardial infarction , atrial fibrillation , etc. ) ; - Diabetes ( fasting glucose > 125 mg / dL ) ; - Treatment with statins ; - Obesity ( BMI > 30 kg / m2 ) ; -HYPERSENSITIVITY known to the study drugs ( ACE inhibitors , hydrochlorothiazide , sulphonamide derivatives ) or any of the excipients . -patients not capable of giving valid consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to confirm a statistically significant difference in terms of reduction of diastolic and systolic blood pressure among patients carriers and non-carriers of the specific genetic profile for each drug ( HCTZ or Peri ) after 4/8 weeks of treatment .;Secondary Objective: Implementation of genetic profiles for HCTZ and Perindopril;Primary end point(s): reduction in blood pressure ( SBP / DBP ) higher in patients carrying the genetic profile ACEi or HCTZ versus patients with no genetic profile;Timepoint(s) of evaluation of this end point: after 4-8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Implement the genetic profiles related to HCTZ and Perindopril Evaluate new genetic profiles in response to drugs Peri ndopril and HCTZ in terms of positive predictive value ( PPV ) and specificity;Timepoint(s) of evaluation of this end point: 4-8 weeks of treatments 4-8 weeks of treatment | — |
Countries
Italy
Contacts
Public ContactUnità di Genomica delle Malattie Re
Ospedale San Raffaele - MI
Outcome results
None listed