N/A
Completed N=1,909
Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril
Hypertension · CHD - Coronary Heart Disease
Source: ClinicalTrials.gov NCT03730116 ↗
Enrolled (actual)
1,909
Serious AEs
0.4%
Results posted
Dec 2020
Primary outcomePrimary: The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline — 31.5 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline |
31.5 | — |
| PRIMARY Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels |
1640 | — |
| PRIMARY Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks |
-3.2 | — |
| PRIMARY Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position |
15.9 | — |
| SECONDARY Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS |
35.1 | — |
| SECONDARY Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice |
1827 | — |
Eligibility Criteria
Inclusion Criteria
- Stable CAD, defined as stable angina pectoris of class 1-3 by CCS (Canadian Cardiovascular Society) classification;
- Previously or newly diagnosed essential hypertension
- Age 18 to 79 years old;
- Informed consent of the patient for participation in the program;
- Decision of the doctor to prescribe bisoprolol/perindopril FDC before the inclusion in the program in accordance to the instruction for use.
Exclusion Criteria
- Stable angina pectoris, class 4;
- History of myocardial infarction or cerebrovascular event within the past 3 months;
- Unstable angina within the past 6 months;
- Chronic heart failure classes 3-4 (NYHA);
- Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus;
- Any serious decompensated concomitant diseases requiring the regular medical therapy;
- Inability to understand the essence of the program and follow the recommendations;
- Contraindications to beta-blockers or ACE inhibitors using;
- Participation of the patient in other trials in the present time or within 30 days before the start of observational program.
Data sourced from ClinicalTrials.gov (NCT03730116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.