NCT03249285

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Mar 2016

Typical duration for phase_3 hypertension

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

February 13, 2017

Last Update Submit

August 10, 2017

Conditions

Hypertension

Keywords

hypertensionpharmacogenomicsanti-hypertensive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Profiles implementation

    in the three months after the end of the study

Study Arms (4)

Peri profile yes

EXPERIMENTAL

patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks

Drug: Peri

HCTZ profile yes

EXPERIMENTAL

patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks

Drug: HCTZ

Peri no profile

ACTIVE COMPARATOR

patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks

Drug: Peri

HCTZ no profile

ACTIVE COMPARATOR

patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks

Drug: HCTZ

Interventions

PeriDRUG

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
Peri no profilePeri profile yes
HCTZDRUG

Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled

Also known as: Hydrochlorothiazide
HCTZ no profileHCTZ profile yes

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female patients aged 25-60 years.
  • Naive hypertensive patients (newly diagnosed, never treated before).
  • Documented mild to moderate arterial hypertension, as defined below:
  • 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);
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienda Sanitaria 6

Livorno, 57121, Italy

RECRUITING

San Raffaele Hospital

Milan, 20131, Italy

RECRUITING

Azienda Ospedaliero - Universitaria S. Maria della Misericordia

Udine, 33170, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

PerindoprilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazides

Study Officials

  • Manunta Paolo, Professor

    Scientif Institute San Raffale

    STUDY CHAIR

Central Study Contacts

Lanzani Chiara, Doctor

CONTACT

+390226435330lanzani.chiara@hsr.it

Brioni Elena, Nurse

CONTACT

+390226432876brioni.elena@hsr.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

February 13, 2017

First Posted

August 15, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

November 1, 2018

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

IT(3)