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

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ClinicalTrials.gov Identifier: NCT03249285
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Chiara Lanzani, Ospedale San Raffaele

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date August 15, 2017
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
Official Title  ICMJE Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
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 (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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Peri
    Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
    Other Name: Perindopril
  • Drug: HCTZ
    Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
    Other Name: Hydrochlorothiazide
Study Arms  ICMJE
  • Experimental: Peri profile yes
    patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
    Intervention: Drug: Peri
  • Experimental: HCTZ profile yes
    patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
    Intervention: Drug: HCTZ
  • 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
    Intervention: Drug: Peri
  • 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
    Intervention: Drug: HCTZ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lanzani Chiara, Doctor +390226435330 lanzani.chiara@hsr.it
Contact: Brioni Elena, Nurse +390226432876 brioni.elena@hsr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249285
Other Study ID Numbers  ICMJE udraCT NUMBER: 2015-001888-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chiara Lanzani, Ospedale San Raffaele
Study Sponsor  ICMJE Ospedale San Raffaele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Manunta Paolo, Professor Scientif Institute San Raffale
PRS Account Ospedale San Raffaele
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP