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

NCT05764317 | Completed

• 1 other identifier: IC4-05153-070-RUS
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension; HTN

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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.

  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

  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

  12 weeks

• To evaluate predictors of reaching BP target goals in the study population

  12 weeks

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Servier

Moscow, 125196, Russia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 10, 2023
• Study Start: April 30, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 20, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)