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)
| Registry | NCT05764317, acronym TARGET |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 409 (Actual) |
| Sponsor | Servier Russia (Industry) |
| Conditions | Arterial Hypertension, HTN |
| Interventions | 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 (Drug) |
| Dates | start 2023-04-30, primary completion 2023-11-30, completion 2024-02-20, first posted 2023-03-10, last updated 2024-04-19 |
| Locations | 1 site in Russia |
Related Papers Related Patents Related Grants Related Experts
All trials for Arterial Hypertension All trials for HTN All trials of Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg All trials of Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg
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.
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.
Sex: All, ages: 18 Years to 80 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Servier | Moscow | Russia |