NCT03730116

Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril

Multicenter Observational Open Program. Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril in Patients With Arterial Hypertension and Stable CAD in Daily Clinical Practice (STYLE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,909 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril 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 facilities.Each 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 bisoprolol/perindopril in patients with arterial hypertension and stable CAD in daily clinical practice (STYLE) Study objectives and purposes: Primary endpoints: * efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP * efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina Secondary endpoints: * impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice * adherence to bisoprolol/perindopril 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

Conditions

• Arterial Hypertension
• CHD - Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	bisoprolol/perindopril FDC	the first and only single-pill combination of beta-blocker and ACE inhibitor

Timeline

• Start date: 2018-11-14
• Primary completion: 2019-10-24
• Completion: 2019-10-24
• First posted: 2018-11-05
• Last updated: 2021-01-13
• Results posted: 2020-12-23

Locations

1 site across 1 country: Russia