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

This study has been completed.
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: April 28, 2015
Last verified: April 2015
Results First Received: April 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Hypertension
Interventions: Drug: Bisoprolol
Drug: Metoprolol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bisoprolol Subjects received 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 was 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 Subjects received 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 was 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.

Participant Flow:   Overall Study
    Bisoprolol     Metoprolol  
STARTED     93     93  
COMPLETED     75     72  
NOT COMPLETED     18     21  
Withdrawal by Subject                 8                 9  
Protocol Violation                 0                 3  
Physician Decision                 2                 1  
Adverse Event                 1                 0  
Lost to Follow-up                 5                 6  
Unspecified                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat (ITT) analysis population included all randomized subjects.

Reporting Groups
  Description
Bisoprolol Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was 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 SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
Metoprolol Subjects received 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 was 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.
Total Total of all reporting groups

Baseline Measures
    Bisoprolol     Metoprolol     Total  
Number of Participants  
[units: participants]
  93     93     186  
Age  
[units: years]
Mean (Standard Deviation)
  51.10  (10.77)     49.89  (10.46)     50.49  (10.60)  
Gender  
[units: Subjects]
     
Female     36     56     92  
Male     57     37     94  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Change From Baseline in 24-hour Blood Pressure Variability at Week 12   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Blood Pressure Response Rate   [ Time Frame: Week 12 ]

11.  Secondary:   Heart Rate Response Rate   [ Time Frame: Week 12 ]

12.  Secondary:   Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


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
Results First Received: April 28, 2015
Last Updated: April 28, 2015
Health Authority: China: Ethics Committee