Effects of the combination of two drugs called irbesartan and amlodipine, in one pill in patients with high blood pressure.

Trial details

Who runs it

Win Medica Pharmaceutical S.A.

Trial code

EU 2024-511705-31-00

Record updated

2025. december 8.

Original description

Efficacy and safety of a fixed-dose combination irbesartan/amlodipine in patients with Arterial Hypertension.Read full original descriptionShow less

A Greek multicenter, single-arm, low-intervention clinical trial to evaluate the efficacy and safety of irbesartan/amlodipine fixed combination in newly diagnosed patients or patients with uncontrolled arterial hypertension.

Efficacy and safety of a fixed-dose combination irbesartan/amlodipine in patients with Arterial Hypertension.

Inclusion: Written and dated informed consent; Male or female patients at least 18 years old; Patients must be willing and able to comply with the requirements and restrictions of this protocol; Newly diagnosed patients with hypertension: i) grade 1, with high cardiovascular risk ii) grade 2, regardless of cardiovascular risk iii) grade 3, regardless of cardiovascular risk b) Patients with uncontrolled hypertension: i) under monotherapy Note: Previous administration of b-blockers for any other indication besides hypertension (e.g. CHD, arrhythmias, hypertrophic cardiomyopathy, hyperthyroidism, HF), may be continued during administration of the study drug, at the discretion of the Investigator. ii) under dual combination therapy with a RAS blocker and a thiazide diuretic; A wash-out period of 4-5 half-lives (t1/2) must have completed for grade 1 and 2 hypertensive patients receiving any prior medication for AH. Note: This may also apply for Grade 3 hypertensive patients, at the discretion of the Investigator; Serum potassium levels within the normal range; Estimated Glomerular Filtration Rate (eGFR) >30mL/min/1.73m2; Ability to swallow tablets.

Exclusion: Patients receiving triple antihypertensive therapy at baseline (screening visit); BP measurement at enrollment visit (start of study drug administration) <140 mm Hg; Use of other investigational medicinal products within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug; Patients with controlled hypertension who are receiving dual antihypertensive treatment, (either fixed or free combination) at baseline (screening visit); Patients receiving a free combination of irbesartan and amlodipine; Existence of an absolute contraindication, according to SmPC and the opinion of the Investigator, due to concomitant medications or comorbidities that may render the study drug administration unsafe; Dementia or other psychiatric illness that precludes the participant's ability to consent and comply with the others of the requirements of the study; History of recent (<6 months) acute cardiovascular event or coronary revascularization procedure (stent or aorto-coronary bypass); History of chronic Atrial Fibrillation or new diagnosis of Atrial Fibrillation at Screening visit; Patients receiving the combination of a renin-angiotensin system blocker and a calcium channel blocker; Female patients during pregnancy, females of reproductive age planning a pregnancy or breastfeeding patients; Severely frail and approaching the end-of-life patients [score≥7, based on the Clinical Frailty Scale (CFS)] or patients with symptomatic hypotension.

EU CTIS 2024-511705-31-00