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

NCT ID: NCT01508325

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-04-30

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.

Detailed Description

Primary objectives:

To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week active treatment in subjects with mild to moderate essential hypertension (EH).

Secondary objectives:

1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (Example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate EH

2. To evaluate safety of the two drugs

3. To evaluate the treatment compliance of the two drugs

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bisoprolol

Group Type: EXPERIMENTAL

Bisoprolol

Intervention Type: 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.

Metoprolol

Group Type: ACTIVE_COMPARATOR

Metoprolol

Intervention Type: 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.

Interventions

Bisoprolol

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.

Intervention Type: DRUG

Metoprolol

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.

Intervention Type: DRUG

Other Intervention Names

Concor; Betaloc SR

Eligibility Criteria

Inclusion Criteria

1. Subjects aged: >=18 years and =<70 years old

2. 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.

3. Clinic resting Heart Rate >=70 beats per minute (bpm)

4. Patients who have signed informed consent

Exclusion Criteria

1. 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.

2. Moderate EH patients who have used anti-hypertension drugs

3. Secondary hypertension

4. Subjects with history of coronary heart disease

5. Chronic or acute heart failure

6. Cerebrovascular events within 6 months before screening

7. Impaired hepatic or renal function (according to local lab standard)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono Co., Ltd., China

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Serono Co., Ltd., China

Locations

Merck Serono Investigational Site

Changsha, , China

Countries

China

Other Identifiers

EMR200006-520

Identifier Type: -

Identifier Source: org_study_id