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)

• Sponsor: Servier Russia (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05764317
• Collaborator: (none)
• Enrollment: 400
• Anticipated Duration (Months): 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension; HTN	Drug: Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg; Drug: Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg; Drug: Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: 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)
• Anticipated Study Start Date: Apr 30, 2023
• Anticipated Primary Completion Date: Jan 30, 2024
• Anticipated Study Completion Date: Feb 20, 2024

Outcome Measures

Primary Outcome Measures

1. 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. [12 weeks]

   Mean change from baseline in SBP (systolic blood pressure) and DBP (diastolic blood pressure) assessed at week 12 of the observational period.

2. 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. [12 weeks]

   Mean change from baseline in LDL-C ( low density lipoprotein cholesterol) assessed at week 12 of the observational period

Secondary Outcome Measures

1. 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]

2. To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period. [12 weeks]

3. 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]

   Mean change from V0 in scores of the SF-36 questionnaire assessed at V1 and V2;

4. 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]

   Proportion of patients with high, moderate and low adherence to the treatment with SPC (single pill combination) of amlodipine/atorvastatin/perindopril at V1 as compared to V0 via medication adherence scale; Proportion of patients with high, moderate and low adherence to the treatment with SPC of amlodipine/atorvastatin/perindopril at V2 as compared to V0 via medication adherence scale;

5. To evaluate predictors of reaching BP target goals in the study population [12 weeks]

   Proportion of patients achieving target BP levels depending on baseline SBP and DBP;

6. To evaluate predictors of reaching LDL-C target goals in the study population [12 weeks]

   Proportion of patients achieving target levels LDL C depending on baseline LDL-C level.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Servier Russia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Servier Russia
• ClinicalTrials.gov Identifier: NCT05764317
• Other Study ID Numbers: IC4-05153-070-RUS
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Dyslipidemias; Amlodipine; Perindopril; Atorvastatin

Study Results

No Results Posted as of Mar 10, 2023