Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259175
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-02-06
Brief 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
Sponsor:
Servier Russia
Organization:
Servier Russia
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIPTYCH
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 amlodipineindapamideperindopril 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None