Clinical trial NCT01190436: A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
Official title: A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Diabetes Mellitus
Bisoprolol
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Inc., Philippines
First posted: 2010-08-27
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Controlled BP
timeFrame: Week 12
measure: Percentage of Participants With Response to Study Drug
timeFrame: Week 12
measure: Mean Change From Baseline in Heart Rate at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline in HbA1c at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Research Site
Study officials:
affiliation: Merck Inc., Philippines
name: Medical Responsible
role: STUDY_DIRECTOR
References: