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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722524
Other study ID # IC4-06593-057-RUS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date July 17, 2019

Study information

Verified date May 2021
Source Servier Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1247
Est. completion date July 17, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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