Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 116 for:    Atenolol

A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01251146
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : November 30, 2012
Last Update Posted : March 8, 2017
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: Treatment
Condition Hypertension
Interventions Drug: Bisoprolol
Drug: Atenolol
Enrollment 177
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased. Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Period Title: Overall Study
Started 86 91
Completed 83 81
Not Completed 3 10
Reason Not Completed
Lost to Follow-up             3             10
Arm/Group Title Bisoprolol Atenolol Total
Hide Arm/Group Description Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased. Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased. Total of all reporting groups
Overall Number of Baseline Participants 86 91 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 91 participants 177 participants
45.44  (9.78) 46.30  (9.87) 45.88  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 91 participants 177 participants
Female
31
  36.0%
38
  41.8%
69
  39.0%
Male
55
  64.0%
53
  58.2%
108
  61.0%
1.Primary Outcome
Title Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
Hide Description Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).
Time Frame Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure. "n" signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: millisecond per millimeter of mercury
Baseline (n=75,79) 7.78  (2.92) 7.92  (3.26)
Change at attainment of heart rate goal (n=67,66) 3.27  (3.67) 2.88  (4.05)
2.Primary Outcome
Title Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
Hide Description Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame Baseline and end of follow-up (Week 4 or Week 6 or Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 71 66
Mean (Standard Deviation)
Unit of Measure: millisecond per millimeter of mercury
4.08  (3.79) 3.31  (3.83)
3.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up
Hide Description Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure. "n" signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: millisecond square (ms^2)
HRV for LF at Baseline (n=75,79) 261.80  (208.40) 322.09  (315.30)
Change for LF: heart rate goal (n=71,71) 90.04  (352.97) 26.14  (416.51)
Change at end of follow-up for LF (n=71,66) 89.40  (330.26) -22.00  (295.54)
HRV for HF at Baseline (n=75,79) 171.26  (161.43) 193.48  (216.06)
Change for HF: heart rate goal (n=71,71) 148.91  (338.13) 136.67  (314.47)
Change at end of follow-up for HF (n=71,66) 186.46  (288.53) 178.05  (375.70)
4.Secondary Outcome
Title Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up
Hide Description Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure. "n" signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 75 79
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n=75,79) 2.16  (1.89) 2.40  (1.96)
Change at attainment of heart rate goal (n=71,71) -0.70  (1.76) -0.90  (1.62)
Change at end of follow-up (n=71,66) -0.69  (2.08) -1.15  (1.68)
5.Secondary Outcome
Title Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
Hide Description Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 86 91
Measure Type: Number
Unit of Measure: participants
Dosage 1 72 72
Dosage 2 7 6
Dosage 3 1 0
6.Secondary Outcome
Title Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
Hide Description Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame Attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 86 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 83.72 79.12
Week 4 91.86 85.71
Week 6 93.02 85.71
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition
Time Frame Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 86 91
Measure Type: Number
Unit of Measure: participants
Number of participants with AEs 6 6
Number of participants with SAEs 0 0
8.Secondary Outcome
Title Number of Participants Compliant With Study Treatment
Hide Description Participants compliant with study treatment were the participants who have completed the study treatment regimen.
Time Frame Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Overall Number of Participants Analyzed 86 91
Measure Type: Number
Unit of Measure: participants
83 81
Time Frame Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased. Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
All-Cause Mortality
Bisoprolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bisoprolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/91 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bisoprolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   6/86 (6.98%)   6/91 (6.59%) 
Cardiac disorders     
Bradycardia *  0/86 (0.00%)  1/91 (1.10%) 
General disorders     
Chest distress *  0/86 (0.00%)  1/91 (1.10%) 
Metabolism and nutrition disorders     
Elevated Triglyceride *  4/86 (4.65%)  4/91 (4.40%) 
Elevated Cholesterol *  2/86 (2.33%)  0/91 (0.00%) 
Nervous system disorders     
Dizziness *  0/86 (0.00%)  2/91 (2.20%) 
Headache *  0/86 (0.00%)  1/91 (1.10%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01251146     History of Changes
Other Study ID Numbers: EMR200006-515
First Submitted: November 30, 2010
First Posted: December 1, 2010
Results First Submitted: November 1, 2012
Results First Posted: November 30, 2012
Last Update Posted: March 8, 2017