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

NCT06259175 | Completed

• 1 other identifier: IC4-06593-082-RUS
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Arterial Hypertension; HTN

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  12 weeks

Secondary Outcomes (7)

• To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.

  4 weeks

• To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.

  4 weeks

• To describe changes in systolic blood pressure (SBP) from baseline to weeks 4 and 8 from the SPC initiation.

  8 weeks

• To describe changes in diastolic blood pressure (DBP) from baseline to weeks 4 and 8 from the SPC initiation.

  8 weeks

• To describe a proportion of patients who reached SBP target goals at week 12 from the SPC initiation.

  12 weeks

Interventions

Amlodipine 5 mg + indapamide 1.25 mg + perindopril 5 mg DRUG

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 mg DRUG

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 mg DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Obtained signed informed consent from the patient.
• Patients of 18 years and older.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Servier

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Indapamide; Perindopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alexandra Konradi

  Medical Education Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: May 1, 2024
• Primary Completion: April 21, 2025
• Study Completion: June 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

RU (1)