The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension (TRICOLOR)

Servier

Status: Completed

Conditions: Arterial Hypertension

Treatments: Drug: amlodipine / indapamide / perindopril arginine FDC

Study type: Observational

Funder types: Industry

Identifiers

NCT03722524

IC4-06593-057-RUS

Details and patient eligibility

About

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 description

It is multicenter, observational, non-controlled, open-label program. The baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat [ITT] population). In case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them.

Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population [PPP]).

The analysis of parameters with normal distribution will be performed using the Student's t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The percentage of patients with normalized BP, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated.

Questionnaires: The score for each scale will be calculated as the sum of scores for questions constituting the scale.

Assessment of the AEs will be carried out in all the patients who started the treatment (ITT population).

Enrollment: 1,247 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,247 participants in 1 patient group

Patients with arterial hypertension

Description:

The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC. Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.

Treatment:

Drug: amlodipine / indapamide / perindopril arginine FDC