Arterial HypertensionTRIPTYCHNCT06259175

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

An observational study of Arterial Hypertension and HTN, run by Servier Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 outpatients with arterial hypertension (HTN) initiated with the amlodipine/indapamide/perindopril SPC in real clinical settings. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arterial Hypertension, HTN
What is being tested?: Amlodipine 5 mg + indapamide 1.25 mg + perindopril 5 mg, Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mg and Amlodipine 10 mg + indapamide 2.5 mg + perindopril 10 mg
How many people: 396 participants
Where: 1 siteRussia
Study dates: 1 May 2024to 1 Jun 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Servier
Moscow

Other trials in Russia

About this study

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.

Read the 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.

Conditions: Arterial Hypertension, HTN
Being tested: Amlodipine 5 mg + indapamide 1.25 mg + perindopril 5 mg, Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mg, Amlodipine 10 mg + indapamide 2.5 mg + perindopril 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 + indapamide 1.25 mg + perindopril 5 mgDrug
a triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation
Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mgDrug
a triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation
Amlodipine 10 mg + indapamide 2.5 mg + perindopril 10 mgDrug
a triple fixed combination of Amlodipine , indapamide and perindopril 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 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
Mean changes from baseline (BL) in SBP (systolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
Measured: 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
Mean changes from baseline (BL) in DBP (diastolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
Measured: 12 weeks

Secondary outcomes (7)

To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Mean change from BL in SBP assessed at V1 (4+1 weeks after the SPC initiation)
Measured: 4 weeks
To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.
Mean change from BL in DBP assessed at V1 (4+1 weeks after the SPC initiation)
Measured: 4 weeks
To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Mean change from BL in SBP assessed at V2 (8+1 weeks after the SPC initiation).
Measured: 8 weeks
To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.
Mean change from BL in SBP and DBP assessed at V2 (8+1 weeks after the SPC initiation).
Measured: 8 weeks
To describe a proportion of patients who reached SBP target goals at week 12 from the SPC initiation.
Proportion of patients who reached SBP ≤130 mm Hg at V3 (12+1 weeks after the SPC initiation).
Measured: 12 weeks
To describe a proportion of patients who reached DBP target goals at week 12 from the SPC initiation.
Prortion of patients who reached DBP <80 mm Hg at V3 (12+1 weeks after the SPC initiation).
Measured: 12 weeks
To describe changes in patients' quality-of-life throughout the observational period of the study.
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).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20241 Jun 2025

First posted14 Feb 2024
Study start1 May 2024
Primary completion21 Apr 2025
Study completion1 Jun 2025

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: 396 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06259175
Sponsor's protocol ID: IC4-06593-082-RUS
Acronym: TRIPTYCH
Status last verified: Jun 2025
First submitted: 6 Feb 2024
Last updated: 11 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH)
ClinicalTrials.gov ID: NCT06259175
Acronym / sponsor ID: TRIPTYCH / IC4-06593-082-RUS
Conditions: Arterial Hypertension, HTN
Study type: Observational
Recruitment status: Completed
Enrolment: 396 participants (actual)
Lead sponsor: Servier RussiaIndustry (pharma, biotech, devices)
Study start: 1 May 2024 (actual)
Primary completion: 21 Apr 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 14 Feb 2024 (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.

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.

Detailed description

Study design

Observational model: Other
Time perspective: Other

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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.

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 + indapamide 1.25 mg + perindopril 5 mga triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation	Drug	–
Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mga triple fixed combination of Amlodipine , indapamide and perindopril combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation	Drug	–
Amlodipine 10 mg + indapamide 2.5 mg + perindopril 10 mga triple fixed combination of Amlodipine , indapamide and perindopril 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 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).
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).

7 secondary outcomes

To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time frame: 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
To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.
Time frame: 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
To describe a proportion of patients who reached SBP target goals at week 12 from the SPC initiation.
Time frame: 12 weeks
To describe a proportion of patients who reached DBP target goals at week 12 from the SPC initiation.
Time frame: 12 weeks
To describe changes in patients' quality-of-life throughout the observational period of the study.
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 11 Jun 2025.

Related trials for Arterial Hypertension

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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
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

Alexandra Konradi principal investigator

Medical Education Institute

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 14 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 11 Jun 2025. 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 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). 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?

On the ClinicalTrials.gov record for NCT06259175.

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 11 Jun 2025.