A Phase 3 interventional study of Peri and HCTZ in Hypertension, sponsored by Ospedale San Raffaele. Status unknown at 3 sites in Italy. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-15.
Sponsored by Ospedale San Raffaele · Phase 3, Interventional, and Treatment
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.
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:
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
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 300 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Documented mild to moderate arterial hypertension, as defined below:
Exclusion Criteria:
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Also known as: Perindopril
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Also known as: Hydrochlorothiazide
SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
Difference in SBP and DBP variation after 4 and 8 weeks of therapy according to the presence or not of specific genetic profile for each drugs
Time frame: 4 and 8 weeks
Profiles implementation
Implementing and redefining the genetic profile for HCTZ or/and Peri by using a further spectrum of 128 different SNP variants
Time frame: in the three months after the end of the study
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Ospedale San Raffaele