Arterial Hypertension Clinical Trial
— TARGETOfficial title:
DescripTion of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/atoRvastatin/Perindopril sinGle Pill Combination trEatmenT in Patients With Arterial Hypertension and Dyslipidemia in the Daily Clinical Practice. (TARGET)
Verified date | April 2024 |
Source | Servier Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 409 |
Est. completion date | February 20, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. - Parameters of interest include measured at rest office BP and LDL-C. Exclusion Criteria: - Subjects who are unwilling or unable to provide a signed informed consent form; - Any contraindication to the treatment with the SPC of amlodipine/atorvastatin/perindopril according to its' approved instruction for medical use in the Russian Federation; - Concomitant use of any other ACE inhibitors, CCBs, ARBs and statins. - Supposed low treatment adherence to the assigned SPC and the risk for poor collaboration between the patient and the investigator during the study; - Any severe, decompensated or unstable somatic diseases or states that according to investigator discretion are life-threatening or worsen the prognosis for the patient: myocardial infarction in the past 3 months, unstable angina, current decompensation of diabetes mellitus, autoimmune or oncological diseases, severe cardiac arrhythmia, gastrointestinal disorders affecting absorbtion, severe hepatic diseases, pancreatic diseases, severe allergic reactions, connective tissue diseases etc; - Secondary arterial hypertension; - Alcohol or any drug abuse; - Surgical intervention on heart or coronary vessels (i.e., heart valve(s) replacement, stent implantation or CABG), or any non-cardiological serious surgical intervention that are planned within next 3 months and may require withdrawal or changes in current therapy; - Glomerular filtration rate less than 60 ml/min/1,72m2; - Participating in any other clinical trial currently or during 30 days period before informed consent was signed. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Servier | Moscow |
Lead Sponsor | Collaborator |
---|---|
Servier Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | ||
Secondary | To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period. | 12 weeks | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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