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Effects of the combination of two drugs called irbesartan and amlodipine, in one pill in patients with high blood pressure.
EU CTIS ID: 2024-511705-31-00
What this study is testing
Efficacy and safety of a fixed-dose combination irbesartan/amlodipine in patients with Arterial Hypertension.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
- 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
You likely can't join if
- Patients receiving triple antihypertensive therapy at baseline (screening visit)
- BP measurement at enrollment visit (start of study drug administration) <140 mm Hg
- Dementia or other psychiatric illness that precludes the participant's ability to consent and comply with the others of the requirements of the study
- 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
See the full eligibility criteria
Who can join
- 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
- 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
- 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
What rules you out
- Patients receiving triple antihypertensive therapy at baseline (screening visit)
- BP measurement at enrollment visit (start of study drug administration) <140 mm Hg
- Dementia or other psychiatric illness that precludes the participant's ability to consent and comply with the others of the requirements of the study
- 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
- 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
- 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
- Severely frail and approaching the end-of-life patients [score≥7, based on the Clinical Frailty Scale (CFS)] or patients with symptomatic hypotension
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.