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

• ClinicalTrials.gov Identifier: NCT01190436
• Recruitment Status: Completed
• First Posted: August 27, 2010
• Results First Posted: May 23, 2014
• Last Update Posted: January 30, 2017
• Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Inc., Philippines
• Information provided by (Responsible Party): Merck KGaA, Darmstadt, Germany

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Bisoprolol	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes
• Study Start Date: December 2009
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bisoprolol	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.; Other Name: Bisoprolol fumarate, Ziac

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 [ Time Frame: Baseline, 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.
2. Percentage of Participants With Controlled BP [ Time Frame: Week 12 ]
   Controlled BP was defined as BP less than 130/80 mmHg.
3. Percentage of Participants With Response to Study Drug [ Time Frame: Week 12 ]
   Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
4. Mean Change From Baseline in Heart Rate at Week 12 [ Time Frame: Baseline, Week 12 ]
   The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.
5. Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :

1. Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: 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.
2. Mean Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, 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.
3. Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 [ Time Frame: Week 12 ]
   Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.
4. Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 [ Time Frame: Baseline, Week 12 ]
   The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.
5. Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12 [ Time Frame: Baseline, 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.
6. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Philippines

Research Site

Manila, Philippines

Sponsors and Collaborators

Merck KGaA, Darmstadt, Germany

Merck Inc., Philippines

Investigators

• Study Director: Medical Responsible; Merck Inc., Philippines

More Information

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT01190436
• Other Study ID Numbers: 200006-512
• First Posted: August 27, 2010
• Results First Posted: May 23, 2014
• Last Update Posted: January 30, 2017
• Last Verified: January 2017

Keywords provided by Merck KGaA, Darmstadt, Germany:

Hypertension; Diabetes Mellitus; Bisoprolol

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Bisoprolol; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action