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

Hypertension Clinical Trial

Official title:

A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190436
• Other study ID #: 200006-512
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: April 24, 2014
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Bisoprolol
Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.

Locations

Country	Name	City	State
Philippines	Research Site	Manila

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Inc., Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 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.	Baseline, Week 12	No
Primary	Percentage of Participants With Controlled BP	Controlled BP was defined as BP less than 130/80 mmHg.	Week 12	No
Primary	Percentage of Participants With Response to Study Drug	Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.	Week 12	No
Primary	Mean Change From Baseline in Heart Rate at Week 12	The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.	Baseline, Week 12	No
Primary	Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12		Week 12	No
Secondary	Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at 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.	Week 12	No
Secondary	Mean Change From Baseline in HbA1c at 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.	Baseline, Week 12	No
Secondary	Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12	Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.	Week 12	No
Secondary	Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12	The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.	Baseline, Week 12	No
Secondary	Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at 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.	Baseline, Week 12	No
Secondary	Number of Participants With Adverse Events (AEs)	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.	Baseline up to Week 12	Yes