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Completed

NCT Number: NCT03722524

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City Policlinic #3, Al'met'yevsk, Russia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amlodipine / indapamide / perindopril arginine FDC

Drug

CCB / diuretic / ACE inhibitor

Other names: CCB / diuretic / ACE inhibitor

Primary outcomes

  1. The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline

    Time frame: Baseline, 3 months

    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.

  2. The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.

    Time frame: Baseline, 3 months

    Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position

Secondary outcomes

  1. Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline

    Time frame: Baseline, 3 months

    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)

  2. 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

    Time frame: Baseline, 3 months

    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.

  3. 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

    Time frame: Baseline, 3 months

    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.

Sponsors and collaborators

Lead sponsor

Servier Russia

Industry

Registry information

Official study title

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"

Acronym: TRICOLOR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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