Arterial hypertension Circulatory System Arterial hypertension
Conditions
Interventions
The aim of the study is to observe the efficacy and safety of treatment with amlodipine/indapamide fixed-dose combination (FDC) ARIFAM in outpatients with hypertension (HT) aged over 55 years.
Sponsors
Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure and heart rate assessed in the seated and standing positions during consultations with the doctor will be measured in addition to self measurements of BP and HR taken twice daily by participants throughout the three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective evaluation of the effectiveness of therapy by the doctor and patient assessed by interview during follow-up visits (after 2 weeks, 1 month and 3 months) | — |
Countries
Russian Federation
Outcome results
None listed