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.

NCT06704815 | Completed

• 1 other identifier: DIM-05985-004
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (1)

Servier Affaires Médicales

Suresnes, 92284, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: January 31, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)