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

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

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.

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