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

January 12, 2017 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Bisoprolol fumarate, Ziac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12
Percentage of Participants With Controlled BP
Time Frame: Week 12
Controlled BP was defined as BP less than 130/80 mmHg.
Week 12
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.
Week 12
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.
Baseline, Week 12
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12
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.
Baseline, Week 12
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.
Week 12
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.
Baseline, Week 12
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.
Baseline, Week 12
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.
Baseline up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Inc., Philippines

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200006-512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Bisoprolol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe