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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Bisoprolol; Drug: Metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01508325

EMR200006-520

Details and patient eligibility

About

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.

Full 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

Enrollment: 186 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)
8. Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Bisoprolol

Experimental group

Treatment:

Drug: Bisoprolol

Metoprolol

Active Comparator group

Treatment:

Drug: Metoprolol