Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730116
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2018-10-22
Brief Title:
Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of BisoprololPerindopril
Sponsor:
Servier Russia
Organization:
Servier Russia
Study Overview
Official Title:
Multicenter Observational Open Program Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of BisoprololPerindopril in Patients With Arterial Hypertension and Stable CAD in Daily Clinical Practice STYLE
Status:
COMPLETED
Status Verified Date:
2020-11
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:
STYLE
Brief Summary:
Study objective - to assess the efficacy tolerability and adherence of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice
Type of the program multicenter observational uncontrolled open program The program will involve 480 general practitioners GPs and cardiologists from the primary care facilitiesEach doctor includes four patients It is planned to include not less than 1920 patients in total
Type of the program multicenter observational uncontrolled open program The program will involve 480 general practitioners GPs and cardiologists from the primary care facilitiesEach doctor includes four patients It is planned to include not less than 1920 patients in total
Detailed Description:
Multicenter observational open program Assessment of the efficacy and tolerability of the fixed-dose combination of bisoprololperindopril in patients with arterial hypertension and stable CAD in daily clinical practice STYLE
Study objectives and purposes
Primary endpoints
efficacy of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP
efficacy of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina
Secondary endpoints
impact on the quality of life of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice
adherence to bisoprololperindopril FDC therapy in patients with HT and stable CAD in everyday practice The program will involve 480 general practitioners GPs and cardiologists from the primary care facilities Each doctor includes four patients It is planned to include not less than 1920 patients in total
Milestones of the program
FSI - November 2018 LSLV- January 2019 Database Lock - February 2019 Statistic Report- May 2019 Clinical Study Report- January 2020
Study objectives and purposes
Primary endpoints
efficacy of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP
efficacy of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina
Secondary endpoints
impact on the quality of life of bisoprololperindopril FDC in patients with HT and stable CAD in everyday practice
adherence to bisoprololperindopril FDC therapy in patients with HT and stable CAD in everyday practice The program will involve 480 general practitioners GPs and cardiologists from the primary care facilities Each doctor includes four patients It is planned to include not less than 1920 patients in total
Milestones of the program
FSI - November 2018 LSLV- January 2019 Database Lock - February 2019 Statistic Report- May 2019 Clinical Study Report- January 2020
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