Evaluation of Efficacy and Safety of Fixed-Dose Combination of Irbesartan and Amlodipine in Patients with Arterial Hypertension

The primary objective of this clinical trial is to evaluate the **efficacy** and **safety** of a fixed-dose combination of irbesartan and amlodipine in patients with **Arterial Hypertension**. This is clinically relevant as it aims to determine the effectiveness of this combination therapy in managing blood pressure in patients who are newly diagnosed or have uncontrolled hypertension, potentially offering a more effective treatment option.

Secondary objectives include:

• Assessing patient compliance with the treatment regimen.
• Determining the percentage of patients who required the administration of a third drug for the management of blood pressure.
• Investigating the association of the study drug's efficacy with the average value of home blood pressure.

The clinical trial focuses on evaluating the efficacy and safety of a fixed-dose combination of irbesartan and amlodipine in patients diagnosed with **arterial hypertension**. The study population includes both male and female participants who are at least 18 years old. The trial does not involve a vulnerable population. Participants are required to have serum potassium levels within the normal range and an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m². They must also be able to swallow tablets. The sponsor has not provided information regarding the total number of participants. The selection criteria include newly diagnosed patients with hypertension of varying grades and patients with uncontrolled hypertension under specific monotherapy or dual combination therapy. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not disclosed additional details about the general health status of the participants.

The clinical trial is designed to evaluate the **efficacy** and safety of a fixed-dose combination of **irbesartan** and **amlodipine** in patients with **arterial hypertension**. This is a Greek multicenter, single-arm, low-intervention study. The trial will involve newly diagnosed patients or those with uncontrolled hypertension. The study will be conducted over an estimated period, with recruitment starting on March 26, 2024, and concluding by August 29, 2025. Participants will be administered the investigational product orally in the form of film-coated tablets, with a maximum daily dose of one tablet and a total treatment period of 17 weeks.

The trial will include several study visits. The initial visit will serve as the inclusion or screening visit, where eligibility criteria will be assessed. Key inclusion criteria include written informed consent, age of at least 18 years, and specific hypertension grades. Exclusion criteria are not specified. Following the screening, participants will undergo a wash-out period if applicable, before starting the intervention. Subsequent follow-up visits will occur at 8-10 weeks and 16 weeks from the start of the intervention to assess the primary endpoints, which include the percentage of patients achieving target systolic blood pressure (SBP) and the assessment of adverse events. Secondary endpoints will evaluate the need for additional antihypertensive medication and the correlation of drug efficacy with home blood pressure monitoring.

The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted. The expected length of participant involvement is approximately 17 weeks. Conditions that may lead to early termination from the study include treatment-related adverse events leading to discontinuation, clinically significant adverse events, or the initiation of a new antihypertensive treatment. The trial aims to provide valuable insights into the management of arterial hypertension using the irbesartan/amlodipine combination.

The clinical trial involves the administration of **Combipress**, a fixed-dose combination medication containing **amlodipine** and **irbesartan**. The trial evaluates four different formulations of Combipress, each presented as a **film-coated tablet** for **oral use**. The formulations include Combipress 300 mg/10 mg, Combipress 150 mg/5 mg, Combipress 300 mg/5 mg, and Combipress 150 mg/10 mg. Each tablet contains the active substances amlodipine and irbesartan, both of which are of chemical origin. The maximum daily dose for each formulation is one tablet, with a total treatment period not exceeding 17 days. The maximum total dose amount is 119 tablets over the course of the study.

Combipress 300 mg/10 mg is administered as a single film-coated tablet per day. This formulation is designed to provide a combination of 300 mg of irbesartan and 10 mg of amlodipine. The administration route is oral, and the treatment duration is limited to a maximum of 17 days. Participant compliance is monitored through daily dosing records and periodic assessments.

Combipress 150 mg/5 mg is similarly administered as a single film-coated tablet per day, containing 150 mg of irbesartan and 5 mg of amlodipine. The administration follows the same oral route, with a treatment period of up to 17 days. Compliance is ensured through regular follow-ups and adherence checks.

Combipress 300 mg/5 mg involves the daily administration of one film-coated tablet, providing 300 mg of irbesartan and 5 mg of amlodipine. The oral administration is consistent with the other formulations, and the treatment period is capped at 17 days. Compliance monitoring is conducted through scheduled visits and medication logs.

Combipress 150 mg/10 mg is administered as one film-coated tablet per day, containing 150 mg of irbesartan and 10 mg of amlodipine. The oral route of administration is maintained, with a treatment duration of up to 17 days. Participant adherence is tracked through routine assessments and medication diaries.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are utilized in this study. The trial focuses solely on the efficacy and safety of the fixed-dose combination of irbesartan and amlodipine in patients with arterial hypertension. Compliance with the dosing schedule is critical and is monitored through various methods, including patient self-reports and clinical evaluations.

The efficacy of the fixed-dose combination of **irbesartan/amlodipine** in patients with arterial hypertension will be assessed through several primary and secondary endpoints. The primary efficacy endpoint involves estimating the percentage of patients who achieve the target systolic blood pressure (SBP) as per the ESC/ESH guidelines for hypertension (2023). This will be evaluated at two specific time points: 8-10 weeks and 16 weeks from the start of the intervention. The assessment will be based on the investigator's judgment.

Secondary efficacy endpoints include the percentage of patients requiring the addition of a third drug to control blood pressure during the 16-week follow-up period. Additionally, the correlation between the efficacy of the study drug and the patient-reported average value of home blood pressure monitoring (HBPM) will be analyzed. These efficacy parameters will be collected and analyzed to determine the effectiveness of the treatment regimen in managing arterial hypertension.