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

NCT01190436 | Completed Phase 4 Results

• 1 other identifier: 200006-512
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Diabetes Mellitus; Bisoprolol

Outcome Measures

Primary Outcomes (5)

• 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

• Percentage of Participants With Controlled BP

  Controlled BP was defined as BP less than 130/80 mmHg.

  Week 12

• 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

• 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

• Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12

  Week 12

Secondary Outcomes (6)

• Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12

  Week 12

• Mean Change From Baseline in HbA1c at Week 12

  Baseline, Week 12

• Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12

  Week 12

• Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12

  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

  Baseline, Week 12

Study Arms (1)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Interventions

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.

Also known as: Bisoprolol fumarate, Ziac

Bisoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Inc., Philippines: collaborator

Study Sites (1)

Research Site

Manila, Philippines

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Bisoprolol; bisoprolol, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Inc., Philippines

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 30, 2017
• Results First Posted: May 23, 2014

Record last verified: 2017-01

Locations

PH (1)