Trial Outcomes & Findings for Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril (NCT NCT03730116)

NCT ID: NCT03730116

Last Updated: 2021-01-13

Results Overview

Changes in the mean office systolic BP levels (in mm Hg) in the sitting position

• Recruitment status: COMPLETED
• Target enrollment: 1909 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-01-13

Participant Flow

Participant milestones

Measure	the Patients With HT and Concomitant Stable CAD Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Inclusion STARTED	1909
Inclusion FVFP	1909
Inclusion COMPLETED	1909
Inclusion NOT COMPLETED	0
1 Month After Inclusion STARTED	1909
1 Month After Inclusion 1 Month After Inclusion	1909
1 Month After Inclusion COMPLETED	1909
1 Month After Inclusion NOT COMPLETED	0
3 Month After Inclusion STARTED	1909
3 Month After Inclusion 3 Month After Inclusion	1909
3 Month After Inclusion COMPLETED	1892
3 Month After Inclusion NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

• in 11 participants no gender indicated

Baseline characteristics by cohort

Measure	the Patients With HT and Concomitant Stable CAD n=1892 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Age, Categorical <=18 years	0 Participants n=1892 Participants
Age, Categorical Between 18 and 65 years	1192 Participants n=1892 Participants
Age, Categorical >=65 years	700 Participants n=1892 Participants
Sex: Female, Male Female	1007 Participants n=1881 Participants • \- in 11 participants no gender indicated
Sex: Female, Male Male	874 Participants n=1881 Participants • \- in 11 participants no gender indicated
Region of Enrollment Russia	1909 participants n=1892 Participants

PRIMARY outcome

Timeframe: 3 months

Changes in the mean office systolic BP levels (in mm Hg) in the sitting position

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline	31.5 mm Hg Standard Deviation 14.2

PRIMARY outcome

Timeframe: 3 month

The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP < 140 mm Hg and DBP < 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels	1640 Participants

PRIMARY outcome

Timeframe: 3 month

Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks	-3.2 number of angina attacks per week Standard Deviation 8.2

PRIMARY outcome

Timeframe: 3 months

Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position	15.9 mm Hg Standard Deviation 9.5

SECONDARY outcome

Timeframe: 3 month

Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS	35.1 units on a scale - mm Standard Deviation 18.5

SECONDARY outcome

Timeframe: 3 month

Percentage of the patients with definite answer on question from questionnaire regarding adherence; (Compliance evaluation test - 6 questions tes; Answer "No" to all questions: good compliance; Answer "Yes" to 1-2 questions: minor compliance; Answer "Yes" to 3 or more questions: noncompliance)

Outcome measures

Measure	Mean of SBP Changes n=1892 Participants Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice	1827 Participants

Adverse Events

the Patients With HT and Concomitant Stable CAD

Serious events: 7 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	the Patients With HT and Concomitant Stable CAD n=1909 participants at risk Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Musculoskeletal and connective tissue disorders Non-traumatic vertebral compression fracture that required hospitalization	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Musculoskeletal and connective tissue disorders death of unknown caus	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Cardiac disorders Hypotension with dizziness	0.10% 2/1909 • Number of events 2 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Product Issues bradycardia	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Cardiac disorders bradycardia	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Cardiac disorders syncope	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.

Other adverse events

Measure	the Patients With HT and Concomitant Stable CAD n=1909 participants at risk Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Respiratory, thoracic and mediastinal disorders Dry cough and tingling throat	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
Cardiac disorders A special situation: use of the drug not daily, but as needed	0.05% 1/1909 • Number of events 1 • 3 month Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.

Additional Information

Mrdical manager - Yuriy Burtsev

Sevier

Phone: 8-495-93707-00

Email: Yuriy.Burtsev@servier.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place