NCT05764317已完成不适用
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)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 12 weeks
Mean change from baseline in SBP (systolic blood pressure) and DBP (diastolic blood pressure) assessed at week 12 of the observational period.
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.
时间窗: 12 weeks
Mean change from baseline in LDL-C ( low density lipoprotein cholesterol) assessed at week 12 of the observational period
次要结局
- To evaluate predictors of reaching BP target goals in the study population(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 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 predictors of reaching LDL-C target goals in the study population(12 weeks)
研究者
研究点 (1)
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