Status:
COMPLETED
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Inc., Philippines
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01190436
Start Date
December 1 2009
End Date
December 1 2011
Last Update
January 30 2017
Active Locations (1)
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1
Research Site
Manila, Philippines