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CompletedNCT06704815EDUHYPERUpdated Nov 26, 2024

Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.

An observational study in Hypertension, sponsored by Servier Affaires Médicales. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Servier Affaires Médicales · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating Viacoram® plus an educational program (NGAYDAUTIEN) in comparison to hypertensive patients initiating other antihypertensive drugs (except single pill combination).

02

Conditions studied

  • Hypertension

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Keywords

  • observational
  • blood pressure
  • SBP
  • DBP
  • hypertension
  • HBP
  • HTA
  • Viacoram®
  • Perindopril arginine and Amlodipine
  • patient educational program
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 400 is above the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Servier Affaires Médicales is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female who have a diagnosis of grade 1 or 2 hypertension and who initiate a new antihypertensive treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged of at least 18 years (without upper limit of age)
  2. Diagnosis of grade 1 or grade 2 hypertension

  3. Naïve of treatment:

    • newly diagnosed hypertension and without treatment with antihypertensive effect for at least 3 months
    • previously diagnosed but without treatment with antihypertensive effect for at least 3 months
  4. Patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period

Exclusion criteria

Exclusion Criteria:

  1. Previously attended to the Ngay Dau Tien educational program for HBP management
  2. Plan to be hospitalized for other medical conditions during the next 6 months
  3. Plan to move/relocate during 6-month follow-up
  4. Have a severe disease (i.e. cirrhosis, end-stage renal disease …)
  5. Are unlikely to cooperate in the study
  6. Arm 1: patient having contra-indication to take Viacoram® according to SmPC
  7. Arm 2: patient showing interest in attending NDT educational program.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • Viacoram® plus educational program

    naïve treatment hypertensive patients who will be initiated to Viacoram® plus an educational program

  • other antihypertensive drugs (except Viacoram®)

    naïve treatment hypertensive patients who will be initiated to any antihypertensive drug (except single pill combination)

06

What researchers measure

Primary outcomes

  1. change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 arms

    Time frame: from baseline to 6-month follow-up

07

Study locations

1 site
  • Servier Affaires Médicales
    Suresnes, 92284, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06704815
Lead sponsor
Servier Affaires Médicales
Responsible party
Sponsor
First posted
Nov 26, 2024
Start date
Jan 31, 2023
Primary completion
Jun 12, 2024
Completion
Jun 12, 2024
Last update
Nov 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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