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

This study is currently recruiting participants.
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01508325
First received: January 9, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a multi-centre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR)


Condition Intervention Phase
Hypertension
 Drug: Bisoprolol
Drug: Metoprolol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Change of mean ambulatory diastolic blood pressure in the last 4 hours after 12-week treatment from baseline (i.e. △DBP) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean heart rate in the last 4 hours after 12-week treatment from baseline (i.e.△HR) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of mean ambulatory systolic blood pressure baseline in the last 4 h (i.e. △SBP) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory 24-h blood pressure [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory daytime blood pressure [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory night-time blood pressure [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory 24-h heart rate [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory daytime heart rate [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory night-time heart rate [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 24-hour variability of blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 24-hour variability of heart rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The response rates for blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    DBP≤90 mmHg or a DBP reduction ≥10 mmHg from baseline

  • The response rates for heart rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    10% HR reduction from baseline


Estimated Enrollment: 184
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bisoprolol Group
Concor 5mg, oral
 Drug: Bisoprolol
The active drug should be taken as close to 8am every morning. Every 4 weeks the dosage need to be up-titrated if the patient's blood pressure (BP) is ≥140 and/or 90mmHg. The first Ambulatory blood pressure monitoring (ABPM) is performed on the last day of the wash-out period. The second ABPM is performed on the last day of the active treatment.
Other Name: Concor
Active Comparator: Metoprolol SR Group
Betaloc ZOK 47.5mg, oral
 Drug: Metoprolol
Comparison of different drug. Metoprolol succinate 47.5mg/tablet, oral

Detailed Description:

Primary objectives:

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

Secondary objectives:

  1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (e.g. blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among patients with mild to moderate essential hypertension
  2. To evaluate the safety of these two study drugs
  3. To evaluate the compliance of the two study drugs
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged: ≥18 years and ≤70 years old.
  2. Essential hypertension (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 patients who have taken anti-hypertension drug.
  3. Clinic resting Heart Rate (HR) ≥70bpm
  4. Patients who have signed informed consent

Exclusion Criteria:

  1. Patients with contraindications according to the China Summary of Product Characteristics (SPCs) 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. Patients 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508325

Contacts
Contact: Study Director +86 (10)5907 2615

Locations
China
Merck Serono Investigational Site Recruiting
Changsha City, China
Sponsors and Collaborators
Merck KGaA
Merck Serono Co., Ltd., China
Investigators
Study Director: Medical Director Merck Serono Co., Ltd., China
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01508325     History of Changes
Other Study ID Numbers: EMR200006-520
Study First Received: January 9, 2012
Last Updated: February 22, 2013
Health Authority: China: Ethics Committee

Keywords provided by Merck KGaA:
Bisoprolol
Hypertension
Blood pressure
Heart rate

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Bisoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013