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Clinical Trial Summary

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are <65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs


Clinical Trial Description

Purpose: To evaluate best medical management to achieve the ESC/ESH 2018 BP goals of 120-129 / 70-79 mmHg in HT patients aged < 65 y not controlled on 3 or more antihypertensive drugs. Study design: Phase A (Active screening) (n = 2500) 7 days Confirmation of the true ineffectiveness of antihypertensive therapy based on 3 or more antihypertensive drugs (single or dual drug preparations) using ABPM and home BP measurements. Phase B (Open-label, non-randomized) (n = 1250) 12 weeks Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual drug preparations) with a triple single pill combination (SPC) based on optimally combined antihypertensive drugs: perindopril + indapamide + amlodipine (P+I+A) or olmesartan + hydrocholothiazide + amlodipine (O+H+A). Phase C (Double blind, randomized, parallel-group) (n = 480) 24 weeks Comparison of antihypertensive efficacy and tolerability profile: - spironolactone - eplerenone - torasemide attached as an antihypertensive drug of 4th choice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06275763
Study type Interventional
Source National Institute of Cardiology, Warsaw, Poland
Contact Piotr Dobrowolski, Professor
Phone (+48) 228156556
Email pdobrowolski@ikard.pl
Status Recruiting
Phase Phase 4
Start date October 20, 2023
Completion date December 31, 2025

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