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An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])

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ClinicalTrials.gov Identifier: NCT01079962
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : October 2, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Merck Ltd.
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 209
Recruitment Details  
Pre-assignment Details A total of 228 participants were screened for the study, out of which 19 were screen failures and 209 participants received the study medication.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks. Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Period Title: Overall Study
Started 105 104
Completed 90 89
Not Completed 15 15
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             5             7
Protocol Violation             2             2
No blood pressure (BP) control             3             0
Inclusion/exclusion criteria             1             3
Participant not returning for next visit             1             0
Due to arrhythmia/bradycardia             1             1
Arm/Group Title Bisoprolol Atenolol Total
Hide Arm/Group Description Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks. Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 105 104 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 104 participants 209 participants
52.0  (11.2) 52.2  (9.3) 52.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
Female
39
  37.1%
46
  44.2%
85
  40.7%
Male
66
  62.9%
58
  55.8%
124
  59.3%
1.Primary Outcome
Title Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12
Hide Description The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
Baseline (n=96, 95) 47.49  (11.33) 45.93  (11.62)
Change in APP at Week 12 (n=90, 89) -4.40  (9.29) -3.69  (8.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in APP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5943
Comments No adjustment of p-value was done and priori threshold was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.701
Confidence Interval (2-Sided) 95%
-1.89 to 3.29
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12
Hide Description The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 85 89
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 46.87  (11.34) 46.53  (11.66)
Change in APP at Week 12 -4.33  (9.66) -3.89  (9.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7561
Comments No adjustment of p-value was done and priori threshold was 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.442
Confidence Interval 95%
-2.36 to 3.24
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Hide Description The change in aortic BP (aortic systolic blood pressure [SBP], aortic diastolic blood pressure [DBP] and aortic mean blood pressure [BP]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in aortic SBP at Week 4 (n=96, 95) -13.90  (12.68) -13.57  (12.73)
Change in aortic SBP at Week 12 (n=90, 89) -15.34  (15.11) -12.71  (14.67)
Change in aortic DBP at Week 4 (n=96, 95) -10.86  (8.23) -9.47  (8.23)
Change in aortic DBP at Week 12 (n=90, 89) -10.94  (9.53) -9.01  (8.79)
Change in aortic mean BP at Week 4 (n=96, 95) -11.88  (8.60) -10.84  (9.07)
Change in aortic mean BP at Week 12 (n=90, 89) -12.41  (10.84) -10.24  (10.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in SBP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8589
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in SBP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2223
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in DBP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2443
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in DBP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1481
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4188
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1586
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12
Hide Description Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Ratio
Change in AIx at Week 4 (n=96, 95) -1.56  (10.43) -0.01  (10.14)
Change in AIx at Week 12 (n=90, 89) 0.61  (9.18) 1.21  (9.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in AIx at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2987
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in AIx at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6584
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12
Hide Description Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Meters per second (m/s)
Change in cfPWV at Week 4 (n=96, 95) -0.60  (1.33) -0.81  (1.15)
Change cfPWV at Week 12 (n=90, 89) -0.72  (1.40) -0.87  (1.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2511
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 4 and Week 12
Hide Description The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
Change in heart rate at Week 4 (n= 96, 95) -6.21  (7.72) -6.20  (8.25)
Change heart rate at Week 12 (n= 90, 89) -8.64  (7.95) -7.84  (9.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9943
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5230
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Aortic Pulse Pressure (APP) at Week 4
Hide Description The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: mmHg
-3.02  (10.56) -4.09  (8.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4447
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Lipid Levels at Week 12
Hide Description The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Milligram/decilitre (mg/dL)
Change in Total cholesterol at Week 12 -3.43  (23.35) -0.37  (24.79)
Change in LDL-cholesterol at Week 12 -2.29  (19.01) 1.31  (17.77)
Change in HDL-cholesterol at Week 12 -1.58  (7.13) -3.02  (7.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3960
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1919
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1896
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Blood Glucose Levels at Week 12
Hide Description The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
-0.23  (17.85) -0.45  (12.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9244
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Hide Description The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.
Time Frame Baseline, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in brachial SBP at Week 4 (n=96, 95) -17.45  (11.74) -17.52  (12.53)
Change in brachial SBP at Week 12 (n=90, 89) -19.10  (14.55) -17.63  (13.74)
Change in brachial DBP at Week 4 (n=96, 95) -12.70  (9.01) -11.36  (8.34)
Change in brachial DBP at Week 12 (n=90, 89) -13.39  (9.90) -10.61  (8.79)
Change in brachial mean BP at Week 4 (n=96, 95) -14.28  (9.28) -13.41  (8.94)
Change in brachial mean BP at Week 12 (n=90, 89) -15.29  (10.78) -12.95  (9.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in SBP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9692
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in SBP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4731
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in DBP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2876
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in DBP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0420
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5100
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bisoprolol, Atenolol
Comments Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1207
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Time Frame Baseline up to Week 14 (follow-up visit)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description:
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
Overall Number of Participants Analyzed 105 104
Measure Type: Number
Unit of Measure: Participants
36 32
Time Frame Baseline up to Week 14 (follow-up visit)
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
 
Arm/Group Title Bisoprolol Atenolol
Hide Arm/Group Description Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks. Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
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   7/105 (6.67%)   3/104 (2.88%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/105 (0.00%)  1/104 (0.96%) 
Diarrhoea * 1  0/105 (0.00%)  1/104 (0.96%) 
General disorders     
Concussion * 1  1/105 (0.95%)  0/104 (0.00%) 
Coronary artery disorder * 1  1/105 (0.95%)  0/104 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal disorder * 1  2/105 (1.90%)  0/104 (0.00%) 
Tendon rupture * 1  1/105 (0.95%)  0/104 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine carcinoma * 1  0/105 (0.00%)  1/104 (0.96%) 
Nervous system disorders     
Headache aggravated * 1  1/105 (0.95%)  0/104 (0.00%) 
Dizziness aggravated * 1  1/105 (0.95%)  0/104 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHO-ART (Ver. 092)
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   29/105 (27.62%)   29/104 (27.88%) 
Cardiac disorders     
Cardiomegaly * 1  1/105 (0.95%)  0/104 (0.00%) 
Eye disorders     
Dry eyes * 1  0/105 (0.00%)  1/104 (0.96%) 
Gastrointestinal disorders     
Heartburn * 1  0/105 (0.00%)  1/104 (0.96%) 
Constipation * 1  1/105 (0.95%)  0/104 (0.00%) 
Abdominal distension * 1  0/105 (0.00%)  1/104 (0.96%) 
Dyspepsia * 1  1/105 (0.95%)  0/104 (0.00%) 
Anorexia * 1  0/105 (0.00%)  1/104 (0.96%) 
Duodenitis * 1  0/105 (0.00%)  1/104 (0.96%) 
Nausea * 1  1/105 (0.95%)  0/104 (0.00%) 
Polyposis gastric * 1  1/105 (0.95%)  0/104 (0.00%) 
General disorders     
Common cold * 1  2/105 (1.90%)  6/104 (5.77%) 
Bronchitis * 1  0/105 (0.00%)  1/104 (0.96%) 
Herpes zoster * 1  0/105 (0.00%)  1/104 (0.96%) 
Cystitis * 1  1/105 (0.95%)  0/104 (0.00%) 
Tinea * 1  1/105 (0.95%)  0/104 (0.00%) 
Upper respiratory tract infection * 1  1/105 (0.95%)  2/104 (1.92%) 
Otitis media * 1  1/105 (0.95%)  0/104 (0.00%) 
AV block first degree * 1  1/105 (0.95%)  0/104 (0.00%) 
Sinus bradycardia * 1  3/105 (2.86%)  4/104 (3.85%) 
Bradyarrhythmia * 1  2/105 (1.90%)  1/104 (0.96%) 
Bladder irritability * 1  1/105 (0.95%)  0/104 (0.00%) 
Ureteral calculus * 1  1/105 (0.95%)  0/104 (0.00%) 
Anaemia * 1  2/105 (1.90%)  0/104 (0.00%) 
Chest tightness of * 1  1/105 (0.95%)  0/104 (0.00%) 
Chest discomfort * 1  0/105 (0.00%)  2/104 (1.92%) 
Chest pressure sensation of * 1  0/105 (0.00%)  1/104 (0.96%) 
Chest pain * 1  4/105 (3.81%)  0/104 (0.00%) 
Oedema * 1  1/105 (0.95%)  0/104 (0.00%) 
Pain groin * 1  1/105 (0.95%)  0/104 (0.00%) 
Face oedema * 1  0/105 (0.00%)  1/104 (0.96%) 
Hot flushes * 1  0/105 (0.00%)  1/104 (0.96%) 
Pain in limb * 1  1/105 (0.95%)  2/104 (1.92%) 
Hepatobiliary disorders     
Gallbladder disorder * 1  0/105 (0.00%)  1/104 (0.96%) 
Liver fatty * 1  0/105 (0.00%)  2/104 (1.92%) 
Metabolism and nutrition disorders     
Hyperlipaemia * 1  1/105 (0.95%)  1/104 (0.96%) 
Hypercholesterolaemia * 1  0/105 (0.00%)  1/104 (0.96%) 
Diabetes mellitus * 1  1/105 (0.95%)  0/104 (0.00%) 
Musculoskeletal and connective tissue disorders     
Cramps * 1  1/105 (0.95%)  0/104 (0.00%) 
Arthralgia aggravated * 1  1/105 (0.95%)  0/104 (0.00%) 
Myalgia * 1  1/105 (0.95%)  1/104 (0.96%) 
Pain neck/shoulder * 1  1/105 (0.95%)  0/104 (0.00%) 
Cartilage damage * 1  1/105 (0.95%)  0/104 (0.00%) 
Back pain aggravated * 1  0/105 (0.00%)  1/104 (0.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine fibromyoma * 1  1/105 (0.95%)  0/104 (0.00%) 
Nervous system disorders     
Paraesthesia * 1  1/105 (0.95%)  1/104 (0.96%) 
Eyelid fluttering * 1  1/105 (0.95%)  0/104 (0.00%) 
Headache * 1  3/105 (2.86%)  1/104 (0.96%) 
Headache aggravated * 1  1/105 (0.95%)  0/104 (0.00%) 
Radiculopathy cervical * 1  1/105 (0.95%)  0/104 (0.00%) 
Dizziness * 1  8/105 (7.62%)  6/104 (5.77%) 
Psychiatric disorders     
Insomnia * 1  0/105 (0.00%)  1/104 (0.96%) 
Libido decreased * 1  0/105 (0.00%)  2/104 (1.92%) 
Sleepiness * 1  0/105 (0.00%)  1/104 (0.96%) 
Reproductive system and breast disorders     
Impotence * 1  0/105 (0.00%)  1/104 (0.96%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis allergic atopic * 1  0/105 (0.00%)  1/104 (0.96%) 
Skin and subcutaneous tissue disorders     
Itching * 1  2/105 (1.90%)  0/104 (0.00%) 
Sweating increased * 1  1/105 (0.95%)  0/104 (0.00%) 
Dermatitis allergic * 1  0/105 (0.00%)  1/104 (0.96%) 
Skin cysts * 1  1/105 (0.95%)  0/104 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHO-ART (Ver. 092)
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01079962     History of Changes
Other Study ID Numbers: EMD 084000-505
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: August 30, 2012
Results First Posted: October 2, 2012
Last Update Posted: February 13, 2014