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NCT06704815Completed

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.

Source: ClinicalTrials.gov · Last updated 26 Nov 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
400 (actual)
First submitted
22 Nov 2024
Start date
31 Jan 2023
Primary completion date
12 Jun 2024
Lead sponsor
Servier Affaires Médicales
NCT number
NCT06704815

What you commit to

  • Study type: Observational
  • Participants enrolled: 400
  • From 31 Jan 2023 to the primary completion date, 12 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously attended to the Ngay Dau Tien educational program for HBP management

Other illness

  • Plan to be hospitalized for other medical conditions during the next 6 months
  • Have a severe disease (i.e. cirrhosis, end-stage renal disease …)

Other

  • Plan to move/relocate during 6-month follow-up
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Servier Affaires Médicales
Coordinator of this site? Confirm its status
SuresnesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.