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

Phase 4

Completed

Conditions: Hypertension

Interventions: Drug: Bisoprolol

Registration Number: NCT01190436

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bisoprolol	Bisoprolol	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12	Baseline, 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.
Percentage of Participants With Controlled BP	Week 12	Controlled BP was defined as BP less than 130/80 mmHg.
Percentage of Participants With Response to Study Drug	Week 12	Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12	Week 12
Mean Change From Baseline in Heart Rate at Week 12	Baseline, Week 12	The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12	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.
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12	Baseline, Week 12	The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.
Mean Change From Baseline in HbA1c at Week 12	Baseline, 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.
Number of Participants With Adverse Events (AEs)	Baseline up to Week 12	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.
Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12	Week 12	Percentage of participants with increased FBS (greater than 16 milligram per deciliter \[mg/dL\] from baseline) at Week 12 was reported.
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12	Baseline, 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.