Amlodipine; Irbesartan for Arterial Hypertension | High blood pressure

Inclusion criteria

• {"criterion_text":"- Written and dated informed consent"}
• {"criterion_text":"- Male or female patients at least 18 years old"}
• {"criterion_text":"- Patients must be willing and able to comply with the requirements and restrictions of this protocol"}
• {"criterion_text":"- a) 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Serum potassium levels within the normal range"}
• {"criterion_text":"- Estimated Glomerular Filtration Rate (eGFR) >30mL/min/1.73m2"}
• {"criterion_text":"- Ability to swallow tablets"}

Exclusion criteria

• {"criterion_text":"- Patients receiving triple antihypertensive therapy at baseline (screening visit)"}
• {"criterion_text":"- BP measurement at enrollment visit (start of study drug administration) <140 mm Hg"}
• {"criterion_text":"- Dementia or other psychiatric illness that precludes the participant's ability to consent and comply with the others of the requirements of the study"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients with controlled hypertension who are receiving dual antihypertensive treatment, (either fixed or free combination) at baseline (screening visit)"}
• {"criterion_text":"- Patients receiving a free combination of irbesartan and amlodipine"}
• {"criterion_text":"- Patients receiving the combination of a renin-angiotensin system blocker and a calcium channel blocker."}
• {"criterion_text":"- Female patients during pregnancy, females of reproductive age planning a pregnancy or breastfeeding patients"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Severely frail and approaching the end-of-life patients [score≥7, based on the Clinical Frailty Scale (CFS)] or patients with symptomatic hypotension"}
• {"criterion_text":"- History of recent (<6 months) acute cardiovascular event or coronary revascularization procedure (stent or aorto-coronary bypass)"}
• {"criterion_text":"- History of chronic Atrial Fibrillation or new diagnosis of Atrial Fibrillation at Screening visit"}

Primary endpoints

• {"endpoint_text":"- Efficacy: Estimation of the percentage of patients who achieved the target SBP, according to the ESC/ESH guidelines for hypertension (2023) and based on Investigator’s judgment, at the following time points from the start of the intervention: 8- 10 weeks and 16 weeks.","definition_or_measurement_approach":"Target SBP achievement assessed per ESC/ESH 2023 guidelines and based on Investigator judgment at 8-10 weeks and 16 weeks from intervention start; percentage of patients meeting target SBP will be estimated."}
• {"endpoint_text":"- Safety: Assessment of adverse events (treatment-related AEs leading to temporary or permanent discontinuation of study drug administration, clinically significant AEs, and SAEs regardless of causality), within 16 weeks from the start of the intervention or until the start of a new antihypertensive lawsuit (whichever occurs first).","definition_or_measurement_approach":"Safety assessed by recording treatment-related AEs leading to temporary/permanent discontinuation, clinically significant AEs and all SAEs regardless of causality, over a follow-up period of up to 16 weeks from intervention start or until initiation of new antihypertensive therapy."}
• {"endpoint_text":"- Patient compliance","definition_or_measurement_approach":"Patient compliance will be assessed (method not specified in CTIS extract)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients who needed the addition of a 3rd drug for controlling their BP during the follow-up period (16 weeks).","definition_or_measurement_approach":"Proportion of patients requiring addition of a third antihypertensive drug during the 16-week follow-up period."}
• {"endpoint_text":"- Correlation of study drug efficacy with the patient-reported, average value of home blood pressure monitoring (HBPM).","definition_or_measurement_approach":"Correlation analysis between study drug efficacy and patient-reported average home BP values (HBPM); measurement based on patient-reported HBPM averages."}

Greece

Earliest CTIS Part Ii Submission Date

01-05-2024

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

587

Number Of Sites

17

Number Of Participants

346

Primary sponsor

Full Name

Win Medica Pharmaceutical S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece

Contract research organisations

Name

Econcare L.P.

Responsibilities

CRO

Third parties

• {"country":"Greece","full_name":"Econcare L.P.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}