Arterial HypertensionTARGETNCT05764317
Description of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/Atorvastatin/Perindopril Single Pill Combination Treatment in Patients With Arterial Hypertension and Dyslipidemia (TARGET)
An observational study of Arterial Hypertension and HTN, run by Servier Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension, HTN
- What is being tested?
- Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg, Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg and Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg
- How many people
- 409 participants
- Where
- 1 siteRussia
- Study dates
- 30 Apr 2023to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with HTN and dyslipidemia who had been initiated with SPC amlodipine/atorvastatin/perindopril within one month before the inclusion
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Arterial Hypertension, HTN
- Being tested
- 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
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mgDrug
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 mgDrug
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 mgDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period.
Measured: 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
Mean change from V0 in scores of the SF-36 questionnaire assessed at V1 and V2;
Measured: 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
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;
Measured: 12 weeks
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;
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start30 Apr 2023
- Primary completion30 Nov 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764317
- Sponsor's protocol ID
- IC4-05153-070-RUS
- Acronym
- TARGET
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05764317
- Acronym / sponsor ID
- TARGET / IC4-05153-070-RUS
- Conditions
- Arterial Hypertension, HTN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with HTN and dyslipidemia who had been initiated with SPC amlodipine/atorvastatin/perindopril within one month before the inclusion
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mga 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 | Drug | – |
| Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mga 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 | Drug | – |
| Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mga 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 | Drug | – |
Primary outcome
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.
Time frame: 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.
Time frame: 12 weeks
Mean change from baseline in LDL-C ( low density lipoprotein cholesterol) assessed at week 12 of the observational period
6 secondary outcomes
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.
Time frame: 12 weeks
To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period.
Time frame: 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
Time frame: 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
Time frame: 12 weeks
To evaluate predictors of reaching BP target goals in the study population
Time frame: 12 weeks
To evaluate predictors of reaching LDL-C target goals in the study population
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and HTN, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.