NCT05764317Completed
Description of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/Atorvastatin/Perindopril Single Pill Combination Treatment in Patients With Arterial Hypertension and Dyslipidemia (TARGET)
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)
Source: ClinicalTrials.gov · Last updated 19 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 409 (actual)
- First submitted
- 9 Feb 2023
- Start date
- 30 Apr 2023
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Servier Russia
- Diseases
- High blood pressure
- NCT number
- NCT05764317
What you commit to
- Study type: Observational
- Participants enrolled: 409
- From 30 Apr 2023 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Alcohol or any drug abuse;
Other illness
- 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;
- 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;
Other
- Subjects who are unwilling or unable to provide a signed informed consent form;
- Supposed low treatment adherence to the assigned SPC and the risk for poor collaboration between the patient and the investigator during the study;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servier Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.