Clinical trial NCT03722524: The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Official 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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 1247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet

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).

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.

Primary outcomes:
measure: The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
timeFrame: Baseline, 3 months
measure: The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline
timeFrame: Baseline, 3 months
measure: 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
timeFrame: Baseline, 3 months
measure: 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
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Almetyevsk
country: Russian Federation
facility: City Policlinic #3
city: Barnaul
country: Russian Federation
facility: City Policlinic # 9
city: Belgorod
country: Russian Federation
facility: City Policlinic # 7
city: Brjansk
country: Russian Federation
facility: City Hospital # 2
city: Chabarowsk
country: Russian Federation
facility: City Policlinic # 15
city: Chelyabinsk
country: Russian Federation
facility: City Policlinic # 8
city: Cherepovets
country: Russian Federation
facility: City Policlinic # 2
city: Ekaterinburg
country: Russian Federation
facility: City Policlinic # 3
city: Irkutsk
country: Russian Federation
facility: City Policlinic # 8
city: Ivanovo
country: Russian Federation
facility: City Policlinic # 5
city: Izhevsk
country: Russian Federation
facility: City Hospital # 1
city: Jaroslavl
country: Russian Federation
facility: City Policlinic # 1
city: Kazan
country: Russian Federation
facility: City Policlinic # 18
city: Kemerovo
country: Russian Federation
facility: City Policlinic # 5
city: Kirov
country: Russian Federation
facility: City Policlinic # 2
city: Krasnoyarsk
country: Russian Federation
facility: City Policlinic # 7
city: Kursk
country: Russian Federation
facility: City Policlinic # 7
city: Moscow
country: Russian Federation
facility: FSBI NMIC of Cardiology of the Ministry of Health of Russia
city: Moscow
country: Russian Federation
facility: City Policlinic # 70
city: Murmansk
country: Russian Federation
facility: City Policlinic # 2
city: Nizhniy Novgorod
country: Russian Federation
facility: City Policlinic # 17
city: Novokuznetsk
country: Russian Federation
facility: City Hospital # 2
city: Novosibirsk
country: Russian Federation
facility: City Policlinic # 14
city: Omsk
country: Russian Federation
facility: City Policlinic # 2
city: Orenburg
country: Russian Federation
facility: Clinic PROM-MED
city: Orël
country: Russian Federation
facility: City Policlinic # 2
city: Penza
country: Russian Federation
facility: Policlinic of Regional Clinic Hospital
city: Perm
country: Russian Federation
facility: Medical Center "Alfa-Center"
city: Petrozavodsk
country: Russian Federation
facility: City Policlinic # 4
city: Pskov
country: Russian Federation
facility: City Policlinic # 3
city: Rostov-on-Don
country: Russian Federation
facility: City Policlinic # 42
city: Ryazan'
country: Russian Federation
facility: City Policlinic # 2
city: Samara
country: Russian Federation
facility: City Policlinic # 8
city: Sankt-Peterburg
country: Russian Federation
facility: City Policlinic # 27
city: Saratov
country: Russian Federation
facility: City Policlinic # 2
city: Sevastopol
country: Russian Federation
facility: City Policlinic # 2
city: Smolensk
country: Russian Federation
facility: Policlinic of Russian railway
city: Stary Oskol
country: Russian Federation
facility: City Policlinic # 2
city: Syktyvkar
country: Russian Federation
facility: City Policlinic # 3
city: Tambov
country: Russian Federation
facility: City Policlinic # 6
city: Tjumen
country: Russian Federation
facility: City Policlinic # 3
city: Toljatti
country: Russian Federation
facility: City Policlinic # 2
city: Tomsk
country: Russian Federation
facility: City Policlinic # 2
city: Tula
country: Russian Federation
facility: Policlinic VIRMED
city: Ufa
country: Russian Federation
facility: City Policlinic # 46
city: Veliky Novgorod
country: Russian Federation
facility: City Policlinic # 4
city: Vladimir
country: Russian Federation
facility: City Policlinic # 4
city: Vladivostok
country: Russian Federation
facility: City Policlinic # 4
city: Volgograd
country: Russian Federation
facility: City Policlinic # 15
city: Vologda
country: Russian Federation
facility: City Policlinic # 3
city: Voronezh
country: Russian Federation
facility: City Policlinic # 7
Study officials:
name: Natatya LOGUNOVA
role: STUDY_CHAIR
References: