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OpenTrials
Completed

NCT Number: NCT06704815

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.

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).

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servier Affaires Médicales

Suresnes, 92284, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged of at least 18 years (without upper limit of age)
  • Diagnosis of grade 1 or grade 2 hypertension
  • 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
  • Patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period

Exclusion criteria

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Acronym: EDUHYPER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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