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

NCT ID: NCT03722524

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1247 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-07-17

Brief Summary

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.

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).

Conditions

Arterial Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

amlodipine / indapamide / perindopril arginine FDC

Intervention Type: DRUG

CCB / diuretic / ACE inhibitor

Interventions

amlodipine / indapamide / perindopril arginine FDC

CCB / diuretic / ACE inhibitor

Intervention Type: DRUG

Other Intervention Names

CCB / diuretic / ACE inhibitor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier Russia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natatya LOGUNOVA

Role: STUDY_CHAIR

Locations

City Policlinic #3

Al'met'yevsk, , Russia

City Policlinic # 9

Barnaul, , Russia

City Policlinic # 7

Belgorod, , Russia

City Hospital # 2

Bryansk, , Russia

City Policlinic # 8

Chelyabinsk, , Russia

City Policlinic # 2

Cherepovets, , Russia

City Policlinic # 8

Irkutsk, , Russia

City Policlinic # 5

Ivanovo, , Russia

City Hospital # 1

Izhevsk, , Russia

City Policlinic # 18

Kazan', , Russia

City Policlinic # 5

Kemerovo, , Russia

City Policlinic # 15

Khabarovsk, , Russia

City Policlinic # 2

Kirov, , Russia

City Policlinic # 7

Krasnoyarsk, , Russia

City Policlinic # 7

Kursk, , Russia

FSBI NMIC of Cardiology of the Ministry of Health of Russia

Moscow, , Russia

City Policlinic # 70

Moscow, , Russia

City Policlinic # 2

Murmansk, , Russia

City Policlinic # 17

Nizhny Novgorod, , Russia

City Hospital # 2

Novokuznetsk, , Russia

City Policlinic # 14

Novosibirsk, , Russia

City Policlinic # 2

Omsk, , Russia

Clinic PROM-MED

Orenburg, , Russia

City Policlinic # 2

Oryol, , Russia

Policlinic of Regional Clinic Hospital

Penza, , Russia

Medical Center "Alfa-Center"

Perm, , Russia

City Policlinic # 4

Petrozavodsk, , Russia

City Policlinic # 3

Pskov, , Russia

City Policlinic # 42

Rostov-on-Don, , Russia

City Policlinic # 2

Ryazan, , Russia

City Policlinic # 27

Saint Petersburg, , Russia

City Policlinic # 8

Samara, , Russia

City Policlinic # 2

Saratov, , Russia

City Policlinic # 2

Sevastopol’, , Russia

Policlinic of Russian railway

Smolensk, , Russia

City Policlinic # 2

Stary Oskol, , Russia

City Policlinic # 3

Syktyvkar, , Russia

City Policlinic # 6

Tambov, , Russia

City Policlinic # 2

Tolyatti, , Russia

City Policlinic # 2

Tomsk, , Russia

Policlinic VIRMED

Tula, , Russia

City Policlinic # 3

Tyumen, , Russia

City Policlinic # 46

Ufa, , Russia

City Policlinic # 4

Veliky Novgorod, , Russia

City Policlinic # 4

Vladimir, , Russia

City Policlinic # 4

Vladivostok, , Russia

City Policlinic # 15

Volgograd, , Russia

City Policlinic # 3

Vologda, , Russia

City Policlinic # 7

Voronezh, , Russia

City Policlinic # 1

Yaroslavl, , Russia

City Policlinic # 3

Yekaterinburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IC4-06593-057-RUS

Identifier Type: -

Identifier Source: org_study_id