Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients

NCT01508325 | Completed Phase 4 Results

• 1 other identifier: EMR200006-520
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.

Conditions

Hypertension

Keywords

Bisoprolol; Hypertension; Blood pressure; Heart rate

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment

  Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (\>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.

  Baseline and Week 12

• Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment

  Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.

  Baseline and Week 12

Secondary Outcomes (10)

• Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment

  Baseline and Week 12

• Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12

  Baseline and Week 12

• Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12

  Baseline and Week 12

• Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12

  Baseline and Week 12

• Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12

  Baseline and Week 12

Study Arms (2)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Metoprolol

ACTIVE COMPARATOR

Drug: Metoprolol

Interventions

Bisoprolol DRUG

Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (\>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was \>=90 mmHg measured every 4 weeks.

Also known as: Concor

Bisoprolol

Metoprolol DRUG

Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was \>=140 mmHg and/or DBP was \>=90 mmHg measured every 4 weeks.

Also known as: Betaloc SR

Metoprolol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged: \>=18 years and =\<70 years old
• EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH subjects who have taken anti-hypertension drug.
• Clinic resting Heart Rate \>=70 beats per minute (bpm)
• Patients who have signed informed consent

You may not qualify if:

• Subjects with contraindications according to the China Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
• Moderate EH patients who have used anti-hypertension drugs
• Secondary hypertension
• Subjects with history of coronary heart disease
• Chronic or acute heart failure
• Cerebrovascular events within 6 months before screening
• Impaired hepatic or renal function (according to local lab standard)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

Merck Serono Investigational Site

Changsha, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Bisoprolol; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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 Director

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 11, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 13, 2015
• Results First Posted: May 13, 2015

Record last verified: 2015-04

Locations

CN (1)