Servier
Moscow, Russia
NCT Number: NCT06259175
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.
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Notify Me18 year and older
All sexes
Observational
Moscow, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 12 weeks
Mean changes from baseline (BL) in SBP (systolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
Time frame: 12 weeks
Mean changes from baseline (BL) in DBP (diastolic blood pressure) assessed at V3 (12+1 weeks after the SPC initiation).
Time frame: 4 weeks
Mean change from BL in SBP assessed at V1 (4+1 weeks after the SPC initiation)
Time frame: 4 weeks
Mean change from BL in DBP assessed at V1 (4+1 weeks after the SPC initiation)
Time frame: 8 weeks
Mean change from BL in SBP assessed at V2 (8+1 weeks after 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).
Time frame: 12 weeks
Proportion of patients who reached SBP ≤130 mm Hg at V3 (12+1 weeks after 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).
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).
Servier Russia
Industry
Acronym: TRIPTYCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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