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This is a multi-centre, observational, ambispective study, which will retrospectively and prospectively collect clinical and socio-demographic data from medical records of outpatients with arterial hypertension (HTN) initiated with the amlodipine/indapamide/perindopril SPC in real clinical settings.
375 patients to be included in the study in order for at least 300 patients to complete the study and provide an estimated 90% power of the study.
75 outpatient general practitioners and cardiologists will participate in this study.
Patients will be managed in accordance with medical standards and clinical guidelines implemented in routine clinical practice. Once a patient is included in the study there will be 2 more additional visits scheduled for assessment of a patient's hemodynamic parameters as well as his/ her eligibility to continue to participate in the study, quality of life and treatment adherence statuses as well as presence or absence of adverse events. Second visit (V2) will be taking place approximately 8 weeks (± 1 week) after the date of the SPC initiation, visit V3 will be taking place approximately 12 weeks (± 1 week) after the date of the SPC initiation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine 5 mg + indapamide 1.25 mg + perindopril 5 mg | Drug | a triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation | ||
| Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mg | Drug | a triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation | ||
| Amlodipine 10 mg + indapamide 2.5 mg + perindopril 10 mg | Drug | a triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation |
| Measure | Description | Time Frame |
|---|---|---|
| To describe antihypertensive effectiveness of the triple single-pill combination (SPC) of amlodipine, indapamide and perindopril in outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12 | Mean changes from baseline (BL) in SBP (systolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation). | 12 weeks |
| To describe antihypertensive effectiveness of the triple single-pill combination (SPC) of amlodipine, indapamide and perindopril in outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12 | Mean changes from baseline (BL) in DBP (diastolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation. | Mean change from BL in SBP assessed at V1 (4+1 weeks after the SPC initiation) | 4 weeks |
| To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12 weeks from the initiation of the SPC.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Konradi | Medical Education Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servier | Moscow | Russia |
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Mean change from BL in DBP assessed at V1 (4+1 weeks after the SPC initiation) |
| 4 weeks |
| To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation. | Mean change from BL in SBP assessed at V2 (8+1 weeks after the SPC initiation). | 8 weeks |
| To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation. | Mean change from BL in SBP and DBP assessed at V2 (8+1 weeks after the SPC initiation). | 8 weeks |
| To describe a proportion of patients who reached SBP target goals at week 12 from the SPC initiation. | Proportion of patients who reached SBP ≤130 mm Hg at V3 (12+1 weeks after the SPC initiation). | 12 weeks |
| To describe a proportion of patients who reached DBP target goals at week 12 from the SPC initiation. | Prortion of patients who reached DBP <80 mm Hg at V3 (12+1 weeks after the SPC initiation). | 12 weeks |
| To describe changes in patients' quality-of-life throughout the observational period of the study. | Mean changes in scores of the Health-related quality of life Questionnaire for Patients with Hypertension (HRQoL) assessed at V3 (12+1 weeks after the SPC initiation). | 12 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D007190 | Indapamide |
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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