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Active Not Recruiting NCT07876895

Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension

Conditions: Essential Hypertension

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 600
Sponsor: Bosnalijek D.D

Location: Clinic for diseases of the heart, blood vessels and rheumatism, Clinical Center University of Sarajevo (KCUS) Sarajevo

Summary

The aim of this observational study is to monitor the effectiveness of therapy, adherence and safety of a fixed combination of perindopril + amlodipine in patients with essential hypertension. The main questions it aims to answer are: * What is the proportion of patients who achieved reduction of blood pressure to normal values according to ESC guidelines or reduction of systolic pressure by 10 to 15 mmHg and diastolic pressure by 5 to 10 mmHg? * What is therapy adherence during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension? * What is the frequency and types of adverse reactions during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension? Participants will be followed for twelve months through five measurements (baseline and one, three, six and twelve months after baseline). Values of heart rate and blood pressure, laboratory data (neutrophils, platelets, triglycerides, total cholesterol, HDL, LDL, AST, ALT, urea, creatinine, sodium, potassium, blood glucose), therapy adherence, adverse drug reactions and concomitant therapy will be recorded at each visit.

Eligibility Criteria

Inclusion Criteria: * Patients older than 18 and younger than 75 years * Patients with essential hypertension with blood pressure values ≥ 140/90 mmHg Exclusion Criteria: * Hypersensitivity to the components of the drug * Positive history of angioneurotic edema * Pregnancy * Breastfeeding * Patients who are planning to become pregnant in the near future * Significant bilateral renal artery stenosis or renal artery stenosis in one functional kidney * Severe hypotension * Obstruction of the outflow tract of the left ventricle of the heart (eg, high-grade aortic stenosis) * Hemodynamically unstable heart failure after acute myocardial infarction * Simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or with renal impairment (GFR \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07876895). StuddyBuddy aggregates publicly available trial information.