Description of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/Atorvastatin/Perindopril Single Pill Combination Treatment in Patients With Arterial Hypertension and Dyslipidemia (TARGET)

Servier

Status: Completed

Conditions: Arterial Hypertension; HTN

Treatments: Drug: Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg; Drug: Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg; Drug: Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT05764317

IC4-05153-070-RUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 409 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design