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

This study has been completed.
Sponsor:
Collaborator:
Merck Inc., Philippines
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01190436
First received: August 26, 2010
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Hypertension
Drug: Bisoprolol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Controlled BP [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Controlled BP was defined as BP less than 130/80 mmHg.

  • Percentage of Participants With Response to Study Drug [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.

  • Mean Change From Baseline in Heart Rate at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.

  • Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.

  • Mean Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.

  • Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 12 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 125
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190436

Locations
Philippines
Research Site
Manila, Philippines
Sponsors and Collaborators
Merck KGaA
Merck Inc., Philippines
Investigators
Study Director: Medical Responsible Merck Inc., Philippines
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01190436     History of Changes
Other Study ID Numbers: 200006-512
Study First Received: August 26, 2010
Results First Received: April 24, 2014
Last Updated: April 24, 2014
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Merck KGaA:
Hypertension
Diabetes Mellitus
Bisoprolol

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Bisoprolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 01, 2014