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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 patients with HTN and dyslipidemia initiated with SPC of amlodipine/atorvastatin/perindopril in real clinical settings.
A total of 80 general practitioners and outpatient cardiologists will participate in this non-interventional study 400 patients should be included in the study.
Treatment with the studied drug:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg | Drug | a triple fixed combination of atorvastatin, perindopril and amlodipinedose combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation | ||
| Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg | Drug | a triple fixed combination of atorvastatin, perindopril and amlodipinedose combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation | ||
| Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg | Drug | a triple fixed combination of atorvastatin, perindopril and amlodipinedose 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 a triple single-pill combination of amlodipine, atorvastatin and perindopril at 12 weeks in patients with arterial hypertension (HTN) and dyslipidemia in the daily clinical practice. | Mean change from baseline in SBP (systolic blood pressure) and DBP (diastolic blood pressure) assessed at week 12 of the observational period. | 12 weeks |
| To describe hypolipidaemic effectiveness of a triple single-pill combination of amlodipine, atorvastatin and perindopril at 12 weeks in patients with arterial hypertension (HTN) and dyslipidemia in the daily clinical practice. | Mean change from baseline in LDL-C ( low density lipoprotein cholesterol) assessed at week 12 of the observational period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of patients who reached systolic (SBP) and diastolic blood pressure (DBP) target goals at weeks 4 and 12 of the observation period respectively. | 12 weeks | |
| To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period. |
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Inclusion Criteria:
Obtained signed informed consent from the patient
Patients of 18 years and older and younger than 80 years.
Start of the treatment with SPC of amlodipine/atorvastatin/perindopril within 1 month from the Index date in accordance with the indication in Russian SmPC.
Presence of the parameters of interest* in the medical records dated with the nearest to the start of SPC amlodipine/atorvastatin/perindopril treatment date.
Exclusion Criteria:
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Patients with HTN and dyslipidemia who had been initiated with SPC amlodipine/atorvastatin/perindopril within one month before the inclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servier | Moscow | 125196 | Russia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 7, 2026 | |
| Reset | Apr 27, 2026 | |
| Release | Apr 29, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2022 |
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| 12 weeks |
| To evaluate the quality of life of patients at visit 1 (V1) and visit 2 (V2) as compared to visit 0 (V0) respectively | Mean change from V0 in scores of the SF-36 questionnaire assessed at V1 and V2; | 12 weeks |
| To evaluate the adherence to treatment with the fixed dose combination of amlodipine/atorvastatin/perindopril in patients included into the study at V1 and V2 as compared to V0 | Proportion of patients with high, moderate and low adherence to the treatment with SPC (single pill combination) of amlodipine/atorvastatin/perindopril at V1 as compared to V0 via medication adherence scale; Proportion of patients with high, moderate and low adherence to the treatment with SPC of amlodipine/atorvastatin/perindopril at V2 as compared to V0 via medication adherence scale; | 12 weeks |
| To evaluate predictors of reaching BP target goals in the study population | Proportion of patients achieving target BP levels depending on baseline SBP and DBP; | 12 weeks |
| To evaluate predictors of reaching LDL-C target goals in the study population | Proportion of patients achieving target levels LDL C depending on baseline LDL-C level. | 12 weeks |
| Reset | May 21, 2026 |
| Release | May 25, 2026 |
| Reset | Jun 18, 2026 |
| Apr 17, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2022 | Apr 17, 2024 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2026 | Apr 27, 2026 | |||
| Apr 29, 2026 | May 21, 2026 | |||
| May 25, 2026 | Jun 18, 2026 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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