Phase 4
Completed N=125
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
Source: ClinicalTrials.gov NCT01190436 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 — 151.7; 12.54; 87.6; 8.48 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 |
151.7; 12.54; 87.6; 8.48 | — |
| PRIMARY Percentage of Participants With Controlled BP |
42.4 | — |
| PRIMARY Percentage of Participants With Response to Study Drug |
44.0 | — |
| PRIMARY Mean Change From Baseline in Heart Rate at Week 12 |
78.2; 8.55 | — |
| PRIMARY Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 |
36.8 | — |
| SECONDARY Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 |
16.8 | — |
| SECONDARY Mean Change From Baseline in HbA1c at Week 12 |
6.28; 0.02 | — |
| SECONDARY Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 |
15.2 | — |
| SECONDARY Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 |
117.1; -5.49 | — |
| SECONDARY Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 |
183.7; 1.25; 105.5; -1.20; 52.0; 0.88 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01190436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.