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

NCT ID: NCT05764317

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 409 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-02-20

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.

Conditions

Arterial Hypertension; HTN

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg

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

Intervention Type: DRUG

Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg

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

Intervention Type: DRUG

Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier Russia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Servier

Moscow, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IC4-05153-070-RUS

Identifier Type: -

Identifier Source: org_study_id