Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05764317
Other study ID # IC4-05153-070-RUS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2023
Est. completion date February 20, 2024

Study information

Verified date April 2024
Source Servier Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 409
Est. completion date February 20, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg
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
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
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

Locations

Country Name City State
Russian Federation Servier Moscow

Sponsors (1)

Lead Sponsor Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period. 12 weeks
Secondary To evaluate the quality of life of patients at visit 1 (V1) and visit 2 (V2) as compared to visit 0 (V0) respectively Mean change from V0 in scores of the SF-36 questionnaire assessed at V1 and V2; 12 weeks
Secondary 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 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; 12 weeks
Secondary To evaluate predictors of reaching BP target goals in the study population Proportion of patients achieving target BP levels depending on baseline SBP and DBP; 12 weeks
Secondary To evaluate predictors of reaching LDL-C target goals in the study population Proportion of patients achieving target levels LDL C depending on baseline LDL-C level. 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05684055 - "Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2) N/A
Active, not recruiting NCT05436730 - "Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Not yet recruiting NCT03294070 - Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension Phase 4
Recruiting NCT01959997 - Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI Phase 2
Completed NCT00983632 - Selective Vagus Nerve Stimulation in Human N/A
Recruiting NCT06098300 - Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
Terminated NCT04677322 - TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
Completed NCT04564118 - A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Completed NCT04278001 - Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement N/A
Withdrawn NCT03047538 - Fixed Combination for Lipid and Blood Pressure Control Phase 4
Completed NCT03046264 - Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis N/A
Completed NCT02620995 - Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction Phase 4
Completed NCT02041832 - Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder N/A
Completed NCT01459120 - Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho N/A
Completed NCT01546181 - Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases
Recruiting NCT01132001 - Ambulatory Versus Home Blood Pressure Measurement N/A
Completed NCT01454583 - Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany N/A
Recruiting NCT03917758 - Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors N/A
Completed NCT03722524 - The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Completed NCT03539627 - Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.