Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH) (TRIPTYCH)

June 6, 2025 updated by: Servier Russia

This is a multi-centre, observational, ambispective study, which will retrospectively and prospectively collect clinical and socio-demographic data from medical records of outpatients with arterial hypertension (HTN) initiated with the amlodipine/indapamide/perindopril SPC in real clinical settings.

375 patients to be included in the study in order for at least 300 patients to complete the study and provide an estimated 90% power of the study.

75 outpatient general practitioners and cardiologists will participate in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be managed in accordance with medical standards and clinical guidelines implemented in routine clinical practice. Once a patient is included in the study there will be 2 more additional visits scheduled for assessment of a patient's hemodynamic parameters as well as his/ her eligibility to continue to participate in the study, quality of life and treatment adherence statuses as well as presence or absence of adverse events. Second visit (V2) will be taking place approximately 8 weeks (± 1 week) after the date of the SPC initiation, visit V3 will be taking place approximately 12 weeks (± 1 week) after the date of the SPC initiation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12 weeks from the initiation of the SPC.

Description

Inclusion Criteria:

  • Obtained signed informed consent from the patient.
  • Patients of 18 years and older.
  • Treatment with the amlodipine/indapamide/perindopril SPC in accordance with the Summary of Product Characteristics (SmPC) approved for medical use in the Russian Federation (RF) (Arterial hypertension - SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg), for a period of 2 to 4 weeks at the time of inclusion in the study.
  • Absence of any other additional antihypertensive medical treatment with β-blockers, α-blockers, I1-imidazoline receptor agonists, loop and potassium-sparing diuretics from the initiation of the SPC to the inclusion visit (V1).
  • Clinical parameters of the primary interest (resting SBP and DBP) are available in medical records for the nearest date before the initiation of the amlodipine/indapamide/perindopril SPC.

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide a signed Informed Consent Form.
  • Any contraindication to the treatment with the amlodipine/indapamide/perindopril SPC according to its' approved SmPC for medical use in RF.
  • Presence of indications for concomitant therapy with β-blockers, α-blockers, I1-imidazoline receptor agonists, loop and potassium-sparing diuretics.
  • Expected poor adherence to the administration of the prescribed SPC due to patient's lack of co-operation that according to the physician's opinion, is likely to jeopardize the interaction between the patient and the investigator during the study.
  • Any severe, decompensated or unstable somatic diseases or conditions that according to investigator discretion are life-threatening or worsen the prognosis for the patient: stroke/TIA, myocardial infarction or unstable angina occurred within 3 months before the inclusion date, angina pectoris IV functional class, chronic heart failure IV functional class by NYHA, current decompensation of diabetes mellitus, autoimmune or oncological diseases, severe or chronic poorly controlled cardiac arrhythmias, gastrointestinal disorders affecting absorption, severe hepatic diseases, pancreatic diseases, severe allergic reactions, connective tissue diseases etc.
  • Secondary arterial hypertension.
  • Alcohol or any drug abuse.
  • Surgical interventions on heart or coronary vessels (i.e., heart valve 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.
  • Participating in any other clinical trial currently or for 30 days period before informed consent was signed.
  • Patient's decision to withdraw from the study due to any reasons.
  • Any contraindication to the treatment with the amlodipine/indapamide/perindopril SPC according to its' approved SmPC for medical use in RF occurred during the follow-up period.
  • Clinical situation(s) requiring adding to the SPC other CV medicines such as β-blockers, α-blockers, I1-imidazoline receptor agonists, diuretics, calcium antagonists and/or ACE inhibitors.
  • Clinical situation(s) requiring withdrawing the SPC from the treatment scheme of a patient.
  • Uncooperative patient's behavior resulting, upon investigating physician's opinion, in resolute unwillingness of the patient to collaborate with the physician therefore jeopardizing effectiveness of the entire treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To describe antihypertensive effectiveness of the triple single-pill combination (SPC) of amlodipine, indapamide and perindopril in outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12
Time Frame: 12 weeks
Mean changes from baseline (BL) in SBP (systolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
12 weeks
To describe antihypertensive effectiveness of the triple single-pill combination (SPC) of amlodipine, indapamide and perindopril in outpatients with arterial hypertension (HTN) who do not receive any other concomitant antihypertensive medicines within 12
Time Frame: 12 weeks
Mean changes from baseline (BL) in DBP (diastolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time Frame: 4 weeks
Mean change from BL in SBP assessed at V1 (4+1 weeks after the SPC initiation)
4 weeks
To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time Frame: 4 weeks
Mean change from BL in DBP assessed at V1 (4+1 weeks after the SPC initiation)
4 weeks
To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time Frame: 8 weeks
Mean change from BL in SBP assessed at V2 (8+1 weeks after the SPC initiation).
8 weeks
To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time Frame: 8 weeks
Mean change from BL in SBP and DBP assessed at V2 (8+1 weeks after the SPC initiation).
8 weeks
To describe a proportion of patients who reached SBP target goals at week 12 from the SPC initiation.
Time Frame: 12 weeks
Proportion of patients who reached SBP ≤130 mm Hg at V3 (12+1 weeks after the SPC initiation).
12 weeks
To describe a proportion of patients who reached DBP target goals at week 12 from the SPC initiation.
Time Frame: 12 weeks
Prortion of patients who reached DBP <80 mm Hg at V3 (12+1 weeks after the SPC initiation).
12 weeks
To describe changes in patients' quality-of-life throughout the observational period of the study.
Time Frame: 12 weeks
Mean changes in scores of the Health-related quality of life Questionnaire for Patients with Hypertension (HRQoL) assessed at V3 (12+1 weeks after the SPC initiation).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Servier Russia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra Konradi, Medical Education Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IC4-06593-082-RUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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