The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.
Research Site
Manila, Philippines
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.
Time frame: Baseline, Week 12
Percentage of Participants With Controlled BP
Controlled BP was defined as BP less than 130/80 mmHg.
Time frame: Week 12
Percentage of Participants With Response to Study Drug
Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
Time frame: Week 12
Mean Change From Baseline in Heart Rate at Week 12
The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.
Time frame: Baseline, Week 12
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
Time frame: Week 12
Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.
Time frame: Week 12
Mean Change From Baseline in HbA1c at Week 12
HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.
Time frame: Baseline, Week 12
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Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12
Percentage of participants with increased FBS (greater than 16 milligram per deciliter \[mg/dL\] from baseline) at Week 12 was reported.
Time frame: Week 12
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12
The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.
Time frame: Baseline, Week 12
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12
The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.
Time frame: Baseline, Week 12
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.
Time frame: Baseline up to Week 12