Evaluation of the efficacy and tolerability of a fixed-dose combination of amlodipine and indapamide in patients older than 55 years

Servier0 个研究点目标入组 2,217 人开始时间: 2019年10月14日最近更新: 2022年3月21日

试验速览

2018 Results article in https://doi.org/10.15829/1560-4071-2018-12-64-74 results (added 12/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35246035/ (added 07/03/2022)

•1. Age 55 years or older
•2. Diagnosis of essential (primary) hypertension
•3. Suboptimal efficacy of the previous antihypertensive therapy, with clinical SBP 140-179 mm Hg, OR untreated grade 1-2 HT with clinical SBP 140-179 mm Hg, in patients requiring therapy with amlodipine and indapamide.
•4. Pulse pressure 60 mm Hg or higher
•5. Doctor's decision to prescribe ARIFAM in line with indications.
•6. Patient’s informed consent to participate in the program
•7. Absence of contraindications to the prescription of ARIFAM, stated in the instruction for medical use of the medicinal product.

•1. Office BP =180/110 mm Hg on the top of treatment (at V1 visit) or =200/110 mm Hg if untreated
•2. Resistant HT (use of at least 3 antihypertensive drug classes, one of which is diuretics, at maximal doses)
•3. Known or suspected symptomatic orthostatic hypotension
•4. History of myocardial infarction or cerebrovascular accident within the past 6 months
•5. Unstable angina within the past 6 months
•6. CHF of class III-IV NYHA
•7. Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus
•8. Any serious decompensated concomitant diseases requiring regular medical therapy
•9. Inability to understand the nature of the program and follow the recommendations
•10. Contraindications or known intolerance to diuretics or calcium channel blockers (indapamide and amlodipine)
•11. Patient who could/would not stop drinking grapefruit juice during the study (interaction with amlodipine)
•12. Current participation in another study or within the preceding 30 days (or a longer period in accordance with local regulations)

发起方