NCT03722524

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

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"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,247 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	amlodipine / indapamide / perindopril arginine FDC	CCB / diuretic / ACE inhibitor

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2018-10-29
• Last updated: 2021-06-10
• Results posted: 2021-03-30

Locations

51 sites across 1 country: Russia