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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Win Medica Pharmaceutical S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

26 Sep 2024 → ongoing

Decision date (initial)

2024-06-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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

Secondary objectives 3

1. Patient compliance
2. Percentage of patients who needed the administration of a third drug for the management of BP
3. Association of the study drug efficacy with the average value of home BP

Conditions and MedDRA coding

Arterial Hypertension

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written and dated informed consent
2. Male or female patients at least 18 years old
3. Patients must be willing and able to comply with the requirements and restrictions of this protocol
4. 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
5. 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.
6. Serum potassium levels within the normal range
7. Estimated Glomerular Filtration Rate (eGFR) >30mL/min/1.73m2
8. Ability to swallow tablets

Exclusion criteria 12

1. Patients receiving triple antihypertensive therapy at baseline (screening visit)
2. Patients with controlled hypertension who are receiving dual antihypertensive treatment, (either fixed or free combination) at baseline (screening visit)
3. Patients receiving a free combination of irbesartan and amlodipine
4. Patients receiving the combination of a renin-angiotensin system blocker and a calcium channel blocker.
5. Female patients during pregnancy, females of reproductive age planning a pregnancy or breastfeeding patients
6. 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
7. Severely frail and approaching the end-of-life patients [score≥7, based on the Clinical Frailty Scale (CFS)] or patients with symptomatic hypotension
8. History of recent (<6 months) acute cardiovascular event or coronary revascularization procedure (stent or aorto-coronary bypass)
9. History of chronic Atrial Fibrillation or new diagnosis of Atrial Fibrillation at Screening visit
10. BP measurement at enrollment visit (start of study drug administration) <140 mm Hg
11. Dementia or other psychiatric illness that precludes the participant's ability to consent and comply with the others of the requirements of the study
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 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.
2. 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).
3. Patient compliance

Secondary endpoints 2

1. Percentage of patients who needed the addition of a 3rd drug for controlling their BP during the follow-up period (16 weeks).
2. Correlation of study drug efficacy with the patient-reported, average value of home blood pressure monitoring (HBPM).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Win Medica Pharmaceutical S.A.

Sponsor organisation

Win Medica Pharmaceutical S.A.

Address

1-3 Oidipodos St And 33-35 Attiki Odos Turnoff

City

Chalandri

Postcode

152 38

Country

Greece

Scientific contact point

Organisation

Win Medica Pharmaceutical S.A.

Contact name

Giota Koufaki

Public contact point

Organisation

Win Medica Pharmaceutical S.A.

Contact name

Giota Koufaki

Third parties 1

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications