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

This study is ongoing, but not recruiting participants.
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 10, 2014
Last verified: February 2014

January 9, 2012
February 10, 2014
December 2011
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Change of mean ambulatory diastolic blood pressure in the last 4 hours after 12-week treatment from baseline (i.e. △DBP) [ Time Frame: 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: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01508325 on ClinicalTrials.gov Archive Site
  • 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 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 ]
  • 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
  • Change of mean ambulatory 24-h heart rate [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory systolic blood pressure baseline in the last 4 h (i.e. △SBP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory 24-h blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory daytime blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory night-time blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory 24-h heart rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory daytime heart rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of mean ambulatory night-time heart rate [ Time Frame: 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
Not Provided
Not Provided
 
Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE Study)

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)

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hypertension
  • Drug: Bisoprolol

    Dose escalation schedule: 5mg 1/d to 7.5mg 1/d to 10mg 1/d.

    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
  • Drug: Metoprolol

    Dose escalation schedule: 47.5mg 1/d to 71.25mg 1/d to 95mg 1/d.

    Comparison of different drug. Metoprolol succinate 47.5mg/tablet, oral

  • Experimental: Bisoprolol Group
    Concor 5mg, oral
    Intervention: Drug: Bisoprolol
  • Active Comparator: Metoprolol SR Group
    Betaloc ZOK 47.5mg, oral
    Intervention: Drug: Metoprolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
187
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01508325
EMR200006-520
No
Merck KGaA
Merck KGaA
Merck Serono Co., Ltd., China
Study Director: Medical Director Merck Serono Co., Ltd., China
Merck KGaA
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP