Skip to main content
OpenTrials
Completed

NCT Number: NCT01190436

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Manila, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisoprolol

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Inc., Philippines

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 27, 2010
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.