Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)

Hypertension Clinical Trial

— PGX-HT  

Official title:

Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03249285
• Other study ID #: udraCT NUMBER: 2015-001888-39
• Status: Recruiting
• Phase: Phase 3
• First received: February 13, 2017
• Last updated: August 10, 2017
• Start date: March 2016
• Est. completion date: November 2018

Study information

• Verified date: August 2017
• Source: Ospedale San Raffaele
• Contact: Lanzani Chiara, Doctor
• Phone: +390226435330
• Email: lanzani.chiara[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male/Female patients aged 25-60 years.

• Naive hypertensive patients (newly diagnosed, never treated before).

• Documented mild to moderate arterial hypertension, as defined below:

1. 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);

2. 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 Criteria:

• 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).

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Sanitaria 6	Livorno
Italy	San Raffaele Hospital	Milan
Italy	Azienda Ospedaliero - Universitaria S. Maria della Misericordia	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 and 8 weeks
Secondary	Profiles implementation	Implementing and redefining the genetic profile for HCTZ or/and Peri by using a further spectrum of 128 different SNP variants	in the three months after the end of the study