The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive theRapy

Overview

The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension: opportunity for effective BP control with cOmbined antihypertensive therapy.

The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice.

Type of program: Multicenter, observational, non-controlled, open-label program.

Investigators: Cardiologists and outpatient (primary care) physicians (general practitioners).

Number of patients: 1,300 hypertensive patients.

Full Title of Study: “Multinational Observational Uncontrolled Open Programme “The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive Therapy”"

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 30, 2020

Interventions

  • Drug: amlodipine / indapamide / perindopril arginine FDC
    • CCB / diuretic / ACE inhibitor

Arms, Groups and Cohorts

  • Patients with arterial hypertension

Clinical Trial Outcome Measures

Primary Measures

  • The effectiveness of triple FDC of amlodipine / indapamide / perindopril arginine in terms of BP control in hypertensive patients from the real clinical practice.
    • Time Frame: 3 months
    • • Office BP and pulse rate measurements

Secondary Measures

  • • The 24-hour BP profile on the top of FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice.
    • Time Frame: 3 months
    • • Ambulatory blood pressure monitoring (ABPM) (in those patients, in whom it is required, according to the decision of treating physician, based on his/her experience and established practice). The BP will be measured on the non-dominant arm. The measurements will be carried out every 15 minutes in the daytime from 7:00 to 23:00 and every 30 minutes in the nighttime from 23:00 to 7:00.
  • • Tolerability of the triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice.
    • Time Frame: 3 months
    • • Assessment of the treatment tolerability by completion of the standard pharmacovigilance form.
  • • Compliance with the treatment with triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice.
    • Time Frame: 3 months
    • • Assessment of the patient’s compliance with the treatment will be carried out using the compliance questionnaire .

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 to 79 years
  • Essential hypertension
  • Patient's consent to participate in the program
  • Doctor's decision to prescribe FDC of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program.

Exclusion Criteria

  • Symptomatic, or secondary arterial hypertension
  • Office BP ≥ 180/110 mm Hg on treatment (at V0 visit)
  • History of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year
  • CHF of class III-IV NYHA
  • Type I diabetes or decompensated type 2 diabetes
  • Diseases with severe organ dysfunction (hepatic failure, renal failure, etc.)
  • Contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ACE inhibitors (including perindopril) and/or their fixed combination
  • Inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the BP self-monitoring.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Servier Russia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yury Karpov, Prof, +7 495 414 68 46, yuri_karpov@inbox.ru

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