NCT03249285

Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)

Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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 (single nucleotide polymorphism) in preliminary genetic profiles and will be treated according to their genetic profile with Peri (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.

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 will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment. Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups. The treatment period will last 8 weeks, while the study about 10-12 weeks Four cases may occur: * patient with HCTZ profile, HCTZ treatment; * patient with Peri profile, Peri treatment; * patient without HCTZ nor Peri profile, randomization for HCTZ or Peri; * patient with both profiles, treatment according to the profile with the higher number of positive contributors. Eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg/die. Titration to Peri 8 mg or HCTZ 25 mg could be possible after 4 weeks treatment. The treatment period will last 8 weeks, while the study about 10-12 weeks

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Peri	Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
DRUG	HCTZ	Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-03-01
• Completion: 2018-11-01
• First posted: 2017-08-15
• Last updated: 2017-08-15

Locations

3 sites across 1 country: Italy