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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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06704815
Acronym
EDUHYPER
Enrollment
400
Registered
2024-11-26
Start date
2023-01-31
Completion date
2024-06-12
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

Brief 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).

Interventions

None listed

Sponsors

Servier Affaires Médicales
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 armsfrom baseline to 6-month follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026