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.

Completed

• Conditions: Hypertension

• Registration Number: NCT06704815
• Lead Sponsor: Servier Affaires Médicales

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 arms	from baseline to 6-month follow-up

Trial Locations

Locations (1)

Servier Affaires Médicales; 🇫🇷 Suresnes, France