Clinical trial NCT05764317: Description of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/Atorvastatin/Perindopril Single Pill Combination Treatment in Patients With Arterial Hypertension and Dyslipidemia (TARGET)
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
HTN
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HTN and dyslipidemia who had been initiated with SPC amlodipine/atorvastatin/perindopril within one month before the inclusion

Brief summary: 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.

Detailed description: Treatment with the studied drug:

* Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg
* Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg
* Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg This is non-interventional study that is observational by its nature. Therefore there will be no any assignments of subjects to a particular therapeutic strategies defined by this protocol. Decision to treat a patient with SPC of amlodipine/ atorvastatin/ perindopril should be at the descretion of a treating investigator and made in accordance to local standards and protocols.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period.
timeFrame: 12 weeks
measure: To evaluate the quality of life of patients at visit 1 (V1) and visit 2 (V2) as compared to visit 0 (V0) respectively
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: To evaluate predictors of reaching BP target goals in the study population
timeFrame: 12 weeks
measure: To evaluate predictors of reaching LDL-C target goals in the study population
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Servier
Study officials:
References: