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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. (EDUHYPER)

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Servier

Status

Completed

Conditions

Hypertension

Study type

Observational

Funder types

Industry

Identifiers

NCT06704815
DIM-05985-004

Details and patient eligibility

About

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).

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  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.

Trial design

400 participants in 2 patient groups

Viacoram® plus educational program
Description:
naïve treatment hypertensive patients who will be initiated to Viacoram® plus an educational program
other antihypertensive drugs (except Viacoram®)
Description:
naïve treatment hypertensive patients who will be initiated to any antihypertensive drug (except single pill combination)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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