Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT) (PGX-HT)

August 10, 2017 updated by: Chiara Lanzani, Ospedale San Raffaele

Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Livorno, Italy, 57121
        • Recruiting
        • Azienda Sanitaria 6
        • Contact:
          • Bigazzi Roberto
      • Milan, Italy, 20131
        • Recruiting
        • San Raffaele Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Simonini Marco, Doctor
        • Sub-Investigator:
          • Tentori Stefano, Doctor
      • Udine, Italy, 33170
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria S. Maria della Misericordia
        • Contact:
          • Leonardo A Sechi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peri profile yes
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Other Names:
  • Perindopril
Experimental: HCTZ profile yes
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Other Names:
  • Hydrochlorothiazide
Active Comparator: Peri no profile
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Other Names:
  • Perindopril
Active Comparator: HCTZ no profile
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Other Names:
  • Hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
Time Frame: 4 and 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profiles implementation
Time Frame: in the three months after the end of the study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Investigators

  • Study Chair: Manunta Paolo, Professor, Scientif Institute San Raffale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • udraCT NUMBER: 2015-001888-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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