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

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"

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.

Study Overview

• Status: Completed
• Conditions: Arterial Hypertension
• Intervention / Treatment: Drug: amlodipine / indapamide / perindopril arginine FDC

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 1247

Contacts and Locations

Study Locations

• Russian Federation
  • Almetyevsk, Russian Federation
    • City policlinic #3
  • Barnaul, Russian Federation
    • City Policlinic # 9
  • Belgorod, Russian Federation
    • City Policlinic # 7
  • Brjansk, Russian Federation
    • City Hospital # 2
  • Chabarowsk, Russian Federation
    • City Policlinic # 15
  • Chelyabinsk, Russian Federation
    • City Policlinic # 8
  • Cherepovets, Russian Federation
    • City Policlinic # 2
  • Ekaterinburg, Russian Federation
    • City Policlinic # 3
  • Irkutsk, Russian Federation
    • City Policlinic # 8
  • Ivanovo, Russian Federation
    • City Policlinic # 5
  • Izhevsk, Russian Federation
    • City hospital # 1
  • Jaroslavl, Russian Federation
    • City Policlinic # 1
  • Kazan, Russian Federation
    • City Policlinic # 18
  • Kemerovo, Russian Federation
    • City Policlinic # 5
  • Kirov, Russian Federation
    • City Policlinic # 2
  • Krasnoyarsk, Russian Federation
    • City Policlinic # 7
  • Kursk, Russian Federation
    • City Policlinic # 7
  • Moscow, Russian Federation, 121552
    • FSBI NMIC of Cardiology of the Ministry of Health of Russia
  • Moscow, Russian Federation
    • City Policlinic # 70
  • Murmansk, Russian Federation
    • City Policlinic # 2
  • Nizhniy Novgorod, Russian Federation
    • City Policlinic # 17
  • Novokuznetsk, Russian Federation
    • City Hospital # 2
  • Novosibirsk, Russian Federation
    • City Policlinic # 14
  • Omsk, Russian Federation
    • City Policlinic # 2
  • Orenburg, Russian Federation
    • Clinic PROM-MED
  • Orël, Russian Federation
    • City Policlinic # 2
  • Penza, Russian Federation
    • Policlinic of Regional Clinic Hospital
  • Perm, Russian Federation
    • Medical Center "Alfa-Center"
  • Petrozavodsk, Russian Federation
    • City Policlinic # 4
  • Pskov, Russian Federation
    • City Policlinic # 3
  • Rostov-on-Don, Russian Federation
    • City Policlinic # 42
  • Ryazan', Russian Federation
    • City Policlinic # 2
  • Samara, Russian Federation
    • City Policlinic # 8
  • Sankt-Peterburg, Russian Federation
    • City Policlinic # 27
  • Saratov, Russian Federation
    • City Policlinic # 2
  • Sevastopol, Russian Federation
    • City Policlinic # 2
  • Smolensk, Russian Federation
    • Policlinic of Russian railway
  • Stary Oskol, Russian Federation
    • City Policlinic # 2
  • Syktyvkar, Russian Federation
    • City Policlinic # 3
  • Tambov, Russian Federation
    • City Policlinic # 6
  • Tjumen, Russian Federation
    • City Policlinic # 3
  • Toljatti, Russian Federation
    • City Policlinic # 2
  • Tomsk, Russian Federation
    • City Policlinic # 2
  • Tula, Russian Federation
    • Policlinic VIRMED
  • Ufa, Russian Federation
    • City Policlinic # 46
  • Veliky Novgorod, Russian Federation
    • City Policlinic # 4
  • Vladimir, Russian Federation
    • City Policlinic # 4
  • Vladivostok, Russian Federation
    • City Policlinic # 4
  • Volgograd, Russian Federation
    • City Policlinic # 15
  • Vologda, Russian Federation
    • City Policlinic # 3
  • Voronezh, Russian Federation
    • City Policlinic # 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with arterial hypertension; 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.

Drug: amlodipine / indapamide / perindopril arginine FDC; CCB / diuretic / ACE inhibitor; Other Names: CCB / diuretic / ACE inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline	Changes in the mean office systolic BP levels (in mm Hg) in the sitting position Blood pressure was measured in accordance with the guidelines of the European Society of Hypertension (ESH) using the auscultatory or oscillometric method and a semi-automated sphygmomanometer. Before taking measurements, the patient remained in a sitting position for 3-5 minutes. Blood pressure was determined on each arm, and the arm with the highest value was taken as the reference. Measurements were taken thrice in the sitting position of a patient, and the average of the second and third BP measurements on the reference arm with an interval of at least 1-2 minutes was recorded.	Baseline, 3 months
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.	Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline	The assessment of the target office BP levels (SBP <140 mm Hg and DBP <90 mm Hg) was performed in accordance with ESC Guidelines for the management of arterial hypertension (2013)	Baseline, 3 months
The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline	Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months
The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline	Change in the mean score of the of the physical component of the SF-36 survey Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Servier Russia
• Investigators: Study Chair: Natatya LOGUNOVA

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sodium Chloride Symporter Inhibitors; Amlodipine; Diuretics; Perindopril; Indapamide; Angiotensin-Converting Enzyme Inhibitors; Indapamide, perindopril drug combination
• Other Study ID Numbers: IC4-06593-057-RUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No