NCT06259175

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 396 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Amlodipine 5 mg + indapamide 1.25 mg + perindopril 5 mg	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
DRUG	Amlodipine 5 mg + indapamide 2.5 mg + perindopril 10 mg	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
DRUG	Amlodipine 10 mg + indapamide 2.5 mg + perindopril 10 mg	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

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-04-21
• Completion: 2025-06-01
• First posted: 2024-02-14
• Last updated: 2025-06-11

Locations

1 site across 1 country: Russia