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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Bisoprolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01190436

200006-512

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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