PHARMACOGENOMICS HYPERTENSION :A NEW APPROACH FOR PERSONALIZED MEDICINE ( PGX - HT )

Phase 1

• Conditions: Hypertension; MedDRA version: 19.0Level: PTClassification code 10051753Term: Vascular calcificationSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001888-39-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified