A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Bisoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg) Aged at least 18 years old Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent Exclusion Criteria: Subjects who were already on beta-blocker therapy at the time of recruitment Subjects with heart rate of at most 60 beats per minute (bpm) at rest Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage Subjects with coronary conduction disorders (bundle branch block) Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease Subjects who are pregnant or expect to be pregnant within the 24-week study period Subjects on oral contraceptives Subjects with asthma or a history of asthma Subjects with documented severe renal disease Subjects on anti-neoplastic drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bisoprolol<br> | Drug: Bisoprolol<br>* 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.<br>* Other names: Bisoprolol fumarate, Ziac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 12 | 
| Percentage of Participants With Controlled BP | Controlled BP was defined as BP less than 130/80 mmHg. | 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. | 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. | Baseline, Week 12 | 
| Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, Week 12 | 
| 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. | 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. | 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. | 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. | Baseline up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diabetes Mellitus, Bisoprolol