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

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ClinicalTrials.gov Identifier: NCT01508325
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Hypertension
Interventions Drug: Bisoprolol
Drug: Metoprolol
Enrollment 186
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 93 93
Completed 75 72
Not Completed 18 21
Reason Not Completed
Withdrawal by Subject             8             9
Protocol Violation             0             3
Physician Decision             2             1
Adverse Event             1             0
Lost to Follow-up             5             6
Other             2             2
Arm/Group Title Bisoprolol Metoprolol Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 93 93 186
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) analysis population included all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 93 participants 186 participants
51.10  (10.77) 49.89  (10.46) 50.49  (10.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 93 participants 186 participants
Female
36
  38.7%
56
  60.2%
92
  49.5%
Male
57
  61.3%
37
  39.8%
94
  50.5%
1.Primary Outcome
Title Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment
Hide Description Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all the randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=92, 93) 85.28  (10.26) 85.68  (11.59)
Change at Week 12 (n=65, 66) -4.45  (10.74) -3.39  (11.23)
2.Primary Outcome
Title Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment
Hide Description Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (n=92, 93) 75.67  (10.58) 73.99  (9.90)
Change at Week 12 (n=65, 66) -8.04  (12.65) -4.75  (11.34)
3.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment
Hide Description The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=92, 93) 132.68  (15.96) 133.24  (16.69)
Change at Week 12 (n=65, 66) -5.97  (16.63) -5.12  (15.12)
4.Secondary Outcome
Title Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12
Hide Description The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP: Baseline (n=92, 93) 132.76  (12.88) 135.43  (15.19)
SBP: Change at Week 12 (n=68, 67) -5.40  (14.59) -4.54  (11.47)
DBP: Baseline (n=92, 93) 84.60  (8.22) 86.94  (10.32)
DBP: Change at Week 12 (n=68, 67) -4.58  (9.01) -3.78  (8.00)
5.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12
Hide Description The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP: Baseline (n=92, 93) 135.40  (13.11) 138.31  (15.09)
SBP: Change at Week 12 (n=68, 67) -5.87  (15.29) -5.16  (12.11)
DBP: Baseline (n=92, 93) 86.43  (8.88) 88.86  (10.58)
DBP: Change at Week 12 (n=68, 67) -4.76  (9.34) -3.82  (8.69)
6.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12
Hide Description The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP: Baseline (n=92, 93) 125.16  (14.14) 127.15  (16.99)
SBP: Change at Week 12 (n=68, 66) -4.81  (14.31) -2.65  (14.23)
DBP: Baseline (n=92, 93) 79.14  (7.68) 81.19  (11.89)
DBP: Change at Week 12 (n=68, 66) -5.08  (9.29) -3.39  (8.76)
7.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12
Hide Description Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (n=92, 93) 80.66  (8.85) 78.94  (8.04)
Change at Week 12 (n=66, 67) -9.60  (10.76) -3.85  (9.21)
8.Secondary Outcome
Title Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12
Hide Description Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (n=92, 93) 67.73  (8.26) 66.85  (7.38)
Change at Week 12 (n=66, 66) -4.72  (9.90) -1.50  (7.24)
9.Secondary Outcome
Title Change From Baseline in 24-hour Blood Pressure Variability at Week 12
Hide Description The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP variability: Baseline (n=91, 92) 10.89  (3.45) 10.45  (2.33)
SBP variability: Change at Week 12 (n=66, 66) -0.12  (3.56) 0.09  (3.05)
DBP variability: Baseline (n=91, 92) 12.68  (3.63) 12.09  (3.02)
DBP variability: Change at Week 12 (n=66, 66) 0.02  (3.54) 0.76  (3.30)
10.Secondary Outcome
Title Blood Pressure Response Rate
Hide Description Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 72
Measure Type: Number
Unit of Measure: percentage of subjects
86.67 83.33
11.Secondary Outcome
Title Heart Rate Response Rate
Hide Description Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 75 72
Measure Type: Number
Unit of Measure: percentage of subjects
72.00 55.56
12.Secondary Outcome
Title Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12
Hide Description Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 93 93
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (n=92, 93) 77.45  (8.42) 75.80  (7.53)
Change at Week 12 (n=67, 67) -8.46  (10.43) -3.24  (8.03)
Time Frame From the first administration of the trial medication up to the end of the treatment (12 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bisoprolol Metoprolol
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Bisoprolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bisoprolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   2/93 (2.15%)   0/93 (0.00%) 
Nervous system disorders     
Dizziness * 1  1/93 (1.08%)  0/93 (0.00%) 
Transient attack * 1  1/93 (1.08%)  0/93 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bisoprolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   17/93 (18.28%)   16/93 (17.20%) 
Cardiac disorders     
Angina * 1  1/93 (1.08%)  0/93 (0.00%) 
Bradycardia * 1  1/93 (1.08%)  0/93 (0.00%) 
Coronary artery disease * 1  1/93 (1.08%)  0/93 (0.00%) 
Myocardial ischemia * 1  0/93 (0.00%)  1/93 (1.08%) 
Palpitation * 1  1/93 (1.08%)  2/93 (2.15%) 
Ventricular premature contraction * 1  1/93 (1.08%)  1/93 (1.08%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/93 (1.08%)  0/93 (0.00%) 
Constipation * 1  1/93 (1.08%)  0/93 (0.00%) 
General disorders     
Fatigue * 1  0/93 (0.00%)  1/93 (1.08%) 
Chest discomfort * 1  0/93 (0.00%)  2/93 (2.15%) 
Infections and infestations     
Nasopharyngitis * 1  1/93 (1.08%)  1/93 (1.08%) 
Urinary tract infection * 1  0/93 (0.00%)  1/93 (1.08%) 
Investigations     
High alanine aminotransferase * 1  1/93 (1.08%)  0/93 (0.00%) 
High serum cholesterol level * 1  3/93 (3.23%)  2/93 (2.15%) 
High blood glucose * 1  1/93 (1.08%)  1/93 (1.08%) 
High blood triglycerides level * 1  2/93 (2.15%)  4/93 (4.30%) 
High serum uric acid level * 1  0/93 (0.00%)  2/93 (2.15%) 
Low high-density lipoprotein level * 1  1/93 (1.08%)  0/93 (0.00%) 
High low-density lipoprotein level * 1  4/93 (4.30%)  3/93 (3.23%) 
Urine leucocyte (positive) * 1  0/93 (0.00%)  1/93 (1.08%) 
Urine protein (positive) * 1  1/93 (1.08%)  0/93 (0.00%) 
Metabolism and nutrition disorders     
Loss of appetite * 1  1/93 (1.08%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal discomfort * 1  0/93 (0.00%)  1/93 (1.08%) 
Nervous system disorders     
Dizziness * 1  2/93 (2.15%)  2/93 (2.15%) 
Headache * 1  2/93 (2.15%)  0/93 (0.00%) 
Somnolence * 1  0/93 (0.00%)  1/93 (1.08%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/93 (1.08%)  0/93 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/93 (0.00%)  1/93 (1.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.
 
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01508325     History of Changes
Other Study ID Numbers: EMR200006-520
First Submitted: January 9, 2012
First Posted: January 11, 2012
Results First Submitted: April 28, 2015
Results First Posted: May 13, 2015
Last Update Posted: May 13, 2015