Status:
UNKNOWN
Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
Lead Sponsor:
Ospedale San Raffaele
Conditions:
Hypertension
Eligibility:
All Genders
25-60 years
Phase:
PHASE3
Brief Summary
This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator controlled study in essential hypertensive patients never treated before. Each patient will be genotyped for SNPs...
Detailed Description
At screening visit each patient will be genotyped for SNPs in preliminary genetic profiles with a custom SNP array. The therapy scheme includes 2-4-week run-in period after which eligible patients wi...
Eligibility Criteria
Inclusion
- Male/Female patients aged 25-60 years.
- Naive hypertensive patients (newly diagnosed, never treated before).
- Documented mild to moderate arterial hypertension, as defined below:
- At Visits 1 and 2 (week -4 and week -2 run-in period) the mean of the last 3 consecutive readings of office SBP must be \>= 140 mmHg and/or DBP must be \>=90 mmHg, when measured by office blood pressure (OBP);
- At Visit 3 (week 0) enrolment , the mean of the last 3 consecutive readings of SBP must be \>= 140 mmHg and \<160 mmHg, and DBP must be \>= 90 mmHg and \<110 mmHg, when measured by OBP.
- Signed informed consent for genotyping.
Exclusion
- known causes of secondary hypertension;
- pregnant, nursing women or women of childbearing potential taking anti-contraceptive medication;
- severe or malignant hypertension;
- history of renal artery disease;
- significant renal disease (estimated creatinine clearance less than 60 mL/min);
- hepatic disease;
- cardiac diseases (myocardial infarction, atrial fibrillation, etc);
- diabetes (fasting plasma glucose \>125mg/dL);
- statin treatment;
- obesity (BMI\>30 kg/m2).
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03249285
Start Date
March 1 2016
End Date
November 1 2018
Last Update
August 15 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Sanitaria 6
Livorno, Italy, 57121
2
San Raffaele Hospital
Milan, Italy, 20131
3
Azienda Ospedaliero - Universitaria S. Maria della Misericordia
Udine, Italy, 33170