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

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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: 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 To evaluate safety of the two drugs 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

  • 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

Exclusion criteria

  • 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)
  • Other protocol defined exclusion criteria could apply

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

Bisoprolol
Experimental group
Treatment:
Drug: Bisoprolol
Metoprolol
Active Comparator group
Treatment:
Drug: Metoprolol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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