Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 134 for:    OLMESARTAN

Olmesartan Comparison to Losartan in Hypertensive Subjects

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: NCT00949884
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : February 28, 2011
Last Update Posted : March 9, 2011
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: olmesartan medoxomil
Drug: Placebo
Drug: losartan potassium
Enrollment 941
Recruitment Details Participants were enrolled at 119 out-patient centers throughout the U.S.: 1976 patients were screened, 1632 were enrolled, and 941 randomized.
Pre-assignment Details Prior to group assignment was a 2-9 day screening period and a 3-4 week single-blind (participant was blinded) placebo run-in period. Participants were randomized in an 8:1:9 ratio to treatment arms as listed.
Arm/Group Title Olmesartan Placebo Followed by Olmesartan Losartan
Hide Arm/Group Description Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Period Title: Overall Study
Started 420 52 469
Completed 370 37 411
Not Completed 50 15 58
Reason Not Completed
Adverse Event             14             3             12
Did not meet inclusion/exclusion             2             1             3
Lost to Follow-up             7             5             5
Physician Decision             5             0             6
Treatment non-compliance             5             0             8
Withdrawal by Subject             13             4             16
Lack of Efficacy             4             2             7
Study terminated by sponsor             0             0             1
Arm/Group Title Olmesartan Placebo Followed by Olmesartan Losartan Total
Hide Arm/Group Description Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks Total of all reporting groups
Overall Number of Baseline Participants 420 52 469 941
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 420 participants 52 participants 469 participants 941 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
385
  91.7%
51
  98.1%
423
  90.2%
859
  91.3%
>=65 years
35
   8.3%
1
   1.9%
46
   9.8%
82
   8.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 420 participants 52 participants 469 participants 941 participants
52.0  (9.84) 49.9  (8.67) 52.1  (9.76) 51.9  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 420 participants 52 participants 469 participants 941 participants
Female
190
  45.2%
27
  51.9%
211
  45.0%
428
  45.5%
Male
230
  54.8%
25
  48.1%
258
  55.0%
513
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 420 participants 52 participants 469 participants 941 participants
Hispanic or Latino
52
  12.4%
7
  13.5%
61
  13.0%
120
  12.8%
Not Hispanic or Latino
368
  87.6%
45
  86.5%
408
  87.0%
821
  87.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 420 participants 52 participants 469 participants 941 participants
American Indian or Alaska Native
4
   1.0%
0
   0.0%
2
   0.4%
6
   0.6%
Asian
25
   6.0%
2
   3.8%
26
   5.5%
53
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
2
   0.4%
2
   0.2%
Black or African American
118
  28.1%
16
  30.8%
133
  28.4%
267
  28.4%
White
273
  65.0%
33
  63.5%
304
  64.8%
610
  64.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.9%
2
   0.4%
3
   0.3%
Hypertension stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 420 participants 52 participants 469 participants 941 participants
Stage I 120 23 134 277
Stage II 300 29 335 664
[1]
Measure Description: Hypertension stage was calculated using the baseline mean BP value. Stage I = systolic blood pressure of 140-159 mmHg and diastolic blood pressure 90-99 mmHg, Stage II = systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 420 participants 52 participants 469 participants 941 participants
169.92  (9.635) 169.46  (9.652) 170.47  (9.906) 170.17  (9.767)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 420 participants 52 participants 469 participants 941 participants
93.73  (19.627) 96.14  (22.611) 94.02  (21.647) 94.01  (20.810)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram/meter^2
Number Analyzed 420 participants 52 participants 469 participants 941 participants
32.41  (6.089) 33.62  (8.103) 32.28  (6.619) 32.41  (6.480)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 420 participants 52 participants 469 participants 941 participants
158.3  (10.41) 157.9  (10.05) 158.3  (10.24) 158.3  (10.29)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 420 participants 52 participants 469 participants 941 participants
101.1  (4.07) 100.8  (3.79) 101.3  (4.14) 101.2  (4.09)
Pulse Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 420 participants 52 participants 469 participants 941 participants
78.8  (11.41) 81.9  (9.88) 78.5  (10.59) 78.9  (10.94)
1.Primary Outcome
Title Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Hide Description The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Day 0, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 384 424 426
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-9.8  (0.50) -9.7  (0.45) -7.1  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.8 to -1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Hide Description The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Day 0, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 417 461 461
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.3  (0.67) -12.0  (0.64) -8.5  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-5.3 to -1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Hide Description The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Day 0, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 384 424 426
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.6  (0.75) -13.6  (0.71) -9.7  (0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-5.8 to -1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.99
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Hide Description The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Day 0, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 417 461 461
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-9.0  (0.44) -8.8  (0.42) -6.2  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-3.8 to -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Hide Description The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 384 424 426
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.8  (0.40) -0.9  (0.38) 0.0  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1121
Comments [Not Specified]
Method ANCOVA
Comments Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.0 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0783
Comments [Not Specified]
Method ANCOVA
Comments Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.0 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.54
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Hide Description The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 384 424 426
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.1  (0.66) -1.4  (0.63) 0.0  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2312
Comments [Not Specified]
Method ANCOVA
Comments Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.9 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0979
Comments [Not Specified]
Method ANCOVA
Comments Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-3.2 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Percentage of Participants Achieving Blood Pressure Goals at Week 4
Hide Description

Percentage of participants who achieved the following goals:

Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 417 461 461
Measure Type: Number
Unit of Measure: percentage of participants analyzed
Systolic BP <140 mmHg 37.9 36.7 25.6
Systolic BP <135 mmHg 28.1 27.1 14.1
Systolic BP <130 mmHg 16.8 16.5 7.2
Systolic BP <120 mmHg 3.1 3.5 2.0
Diastolic BP <90 mmHg 39.6 38.8 24.5
Diastolic BP <85 mmHg 24.2 23.9 13.0
Diastolic BP <80 mmHg 10.6 10.4 4.6
Blood pressure <140/90 mmHg 27.3 26.5 14.3
Blood pressure <135/80 mmHg 7.4 7.6 2.2
Blood pressure <130/80 mmHg 5.5 5.9 1.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <140 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <140 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <135 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <135 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <130 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <130 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <120 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2755
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <120 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1646
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <85 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <85 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <140/90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <140/90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <135/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <135/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <130/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <130/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
8.Other Pre-specified Outcome
Title Percentage of Participants Achieving Blood Pressure Goals at Week 8
Hide Description

Percentage of participants who achieved the following goals:

Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 384 424 426
Measure Type: Number
Unit of Measure: percentage of participants analyzed
Systolic BP <140 mmHg 41.1 41.0 28.9
Systolic BP <135 mmHg 29.9 30.0 20.4
Systolic BP <130 mmHg 18.2 18.4 13.1
Systolic BP <120 mmHg 6.8 6.6 3.8
Diastolic BP <90 mmHg 43.2 42.5 30.5
Diastolic BP <85 mmHg 22.9 22.9 15.5
Diastolic BP <80 mmHg 12.2 11.8 6.6
Blood pressure <140/90 mmHg 32.6 31.6 19.5
Blood pressure <135/80 mmHg 10.2 9.9 4.9
Blood pressure <130/80 mmHg 7.6 7.5 4.5
Blood pressure <120/80 mmHg 4.9 4.7 2.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <140 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <140 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <135 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <135 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <130 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <130 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0280
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <120 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0519
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving systolic blood pressure goal of <120 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0605
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <85 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <85 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving diastolic blood pressure goal of <80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <140/90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <140/90 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <135/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <135/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <130/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0589
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <130/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0594
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <120/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Percentage of participants achieving blood pressure goal of <120/80 mmHg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0657
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.
9.Other Pre-specified Outcome
Title Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4
Hide Description In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 108 118 118
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic blood pressure -7.3  (1.08) -7.3  (1.03) -5.9  (1.03)
Diastolic blood pressure -4.9  (0.70) -4.8  (0.67) -3.7  (0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Change from baseline at week 4 in systolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3250
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-4.4 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Change from baseline at week 4 in systolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3491
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-4.4 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Change from baseline at week 4 in diastolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2085
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.2 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Change from baseline at week 4 in diastolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2542
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-3.0 to 0.8
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8
Hide Description In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 98 106 110
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic blood pressure -9.1  (1.16) -9.2  (1.11) -5.6  (1.09)
Diastolic blood pressure -6.1  (0.78) -6.1  (0.75) -3.6  (0.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Change from baseline at week 8 in systolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-6.6 to -0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Change from baseline at week 8 in systolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-6.6 to -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Change from baseline at week 8 in diastolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0175
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.5 to -0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Change from baseline at week 8 in diastolic blood pressure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-4.4 to -0.4
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4
Hide Description In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 108 118 118
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Daytime systolic blood pressure -7.6  (1.27) -7.5  (1.22) -5.8  (1.22)
Daytime diastolic blood pressure -5.4  (0.84) -5.2  (0.81) -3.5  (0.81)
Nighttime systolic blood pressure -6.7  (1.15) -6.8  (1.10) -5.5  (1.10)
Nighttime diastolic blood pressure -4.4  (0.77) -4.3  (0.74) -3.4  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Daytime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3104
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-5.2 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Daytime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3653
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-4.9 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Daytime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1197
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.1 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Daytime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1654
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-3.9 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Nighttime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4362
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-4.4 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Nighttime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4039
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-4.5 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Nighttime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3929
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.1 to 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Nighttime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4259
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.0 to 1.3
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8
Hide Description In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 98 106 110
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Daytime systolic blood pressure -8.7  (1.24) -8.7  (1.20) -5.2  (1.17)
Daytime diastolic blood pressure -6.2  (0.86) -6.1  (0.83) -3.7  (0.82)
Nighttime systolic blood pressure -9.3  (1.32) -9.3  (1.27) -6.3  (1.25)
Nighttime diastolic blood pressure -6.2  (0.91) -6.1  (0.87) -4.1  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Daytime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0396
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-6.8 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Daytime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0345
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-6.8 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Daytime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0324
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.8 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Daytime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0363
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-4.7 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Nighttime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0988
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-6.5 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan
Comments Nighttime systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0926
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-6.4 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments Nighttime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0900
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.5 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments Nighttime diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0942
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.4 to 0.3
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4
Hide Description In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 108 118 118
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
2 hour systolic blood pressure -8.7  (1.31) -8.4  (1.26) -6.8  (1.26)
2 hour diastolic blood pressure -5.8  (0.94) -5.6  (0.90) -3.8  (0.90)
4 hour systolic blood pressure -8.4  (1.23) -8.3  (1.18) -6.5  (1.18)
4 hour diastolic blood pressure -5.8  (0.85) -5.6  (0.82) -4.1  (0.82)
6 hour systolic blood pressure -8.0  (1.18) -8.0  (1.13) -6.2  (1.13)
6 hour diastolic blood pressure -5.5  (0.83) -5.4  (0.79) -3.9  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 2 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3229
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-5.4 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 2 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3863
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-5.1 to 2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 2 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1277
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.5 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 2 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1799
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-4.3 to 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 4 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2708
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-5.1 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 4 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3133
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-5.0 to 1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 4 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1621
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-3.9 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 4 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2314
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.7 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 6 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2461
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.0 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 6 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2558
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-5.0 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 6 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1700
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-3.8 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 6 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2011
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.7 to 0.8
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8
Hide Description In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 98 106 110
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
2 hour systolic blood pressure -10.0  (1.56) -9.5  (1.50) -7.2  (1.48)
2 hour diastolic blood pressure -6.3  (1.10) -6.0  (1.06) -4.0  (1.04)
4 hour systolic blood pressure -10.5  (1.40) -10.1  (1.35) -6.9  (1.32)
4 hour diastolic blood pressure -7.1  (0.96) -6.7  (0.93) -4.1  (0.91)
6 hour systolic blood pressure -10.0  (1.33) -9.7  (1.28) -6.5  (1.25)
6 hour diastolic blood pressure -6.8  (0.92) -6.5  (0.89) -4.0  (0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 2 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1895
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-7.0 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 2 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2701
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-6.5 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 2 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1328
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-5.2 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 2 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1778
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.9 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 4 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0620
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-7.3 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 4 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1011
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-6.9 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 4 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0249
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-5.6 to -0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 4 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0497
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-5.2 to 0.0
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 6 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0552
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-7.1 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 6 hour systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0767
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.8 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
Comments 6 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-5.3 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
Comments 6 hour diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0434
Comments [Not Specified]
Method ANCOVA
Comments Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-5.0 to -0.1
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure
Hide Description The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.
Arm/Group Title Olmesartan Placebo Followed by Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 417 50 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Diastolic blood pressure -8.3  (0.42) -4.0  (1.22)
Systolic blood pressure -11.9  (0.65) -3.3  (1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan, Placebo Followed by Olmesartan
Comments Diastolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-6.8 to -1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan, Placebo Followed by Olmesartan
Comments Systolic blood pressure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Treatment is a fixed effect and baseline blood pressure is a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-12.5 to -4.7
Estimation Comments [Not Specified]
16.Post-Hoc Outcome
Title Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8
Hide Description Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.
Arm/Group Title Olmesartan Combined Olmesartan Losartan
Hide Arm/Group Description:
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Overall Number of Participants Analyzed 98 106 110
Measure Type: Number
Unit of Measure: percentage of population
Mean 24-hour 59.2 58.5 40.9
Mean Daytime 32.7 32.1 21.8
Mean Nighttime 76.5 77.4 66.4
Time Frame Day 1 to Week 8, or until the adverse event resolved or the condition stabilized.
Adverse Event Reporting Description Safety population includes all participants who received at least 1 dose of double-blind randomized study medication
 
Arm/Group Title Olmesartan Placebo Followed by Olmesartan Losartan
Hide Arm/Group Description Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
All-Cause Mortality
Olmesartan Placebo Followed by Olmesartan Losartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan Placebo Followed by Olmesartan Losartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/420 (0.00%)   0/52 (0.00%)   4/469 (0.85%) 
General disorders       
Non-cardiac chest pain  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Infections and infestations       
Urinary tract infection  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Nervous system disorders       
Cerebrovasular accident  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olmesartan Placebo Followed by Olmesartan Losartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   133/420 (31.67%)   21/52 (40.38%)   148/469 (31.56%) 
Blood and lymphatic system disorders       
Anaemia  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Iron deficiency anaemia  1  0/420 (0.00%)  1/52 (1.92%)  0/469 (0.00%) 
Cardiac disorders       
Palpitations  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Tachycardia  1  1/420 (0.24%)  0/52 (0.00%)  4/469 (0.85%) 
Congenital, familial and genetic disorders       
Type II hyperlipidaemia  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Ear and labyrinth disorders       
Ear discomfort  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Ear pain  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Hypoacusis  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Tinnitus  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  2/420 (0.48%)  0/52 (0.00%)  0/469 (0.00%) 
Eye disorders       
Conjunctivitis  1  1/420 (0.24%)  0/52 (0.00%)  3/469 (0.64%) 
Diplopia  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Eye pruritus  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Eye swelling  1  0/420 (0.00%)  1/52 (1.92%)  0/469 (0.00%) 
Vision blurred  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Abdominal distension  1  1/420 (0.24%)  0/52 (0.00%)  2/469 (0.43%) 
Abdominal pain lower  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Constipation  1  5/420 (1.19%)  1/52 (1.92%)  4/469 (0.85%) 
Diarrhoea  1  5/420 (1.19%)  1/52 (1.92%)  3/469 (0.64%) 
Dyspepsia  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Dysphagia  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Flatulence  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Gastrooesophageal reflux disease  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Inguinal hernia  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Lip swelling  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Nausea  1  7/420 (1.67%)  2/52 (3.85%)  9/469 (1.92%) 
Proctitis ulcerative  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Toothache  1  1/420 (0.24%)  1/52 (1.92%)  2/469 (0.43%) 
Vomiting  1  0/420 (0.00%)  0/52 (0.00%)  3/469 (0.64%) 
General disorders       
Asthenia  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Chest discomfort  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Chest pain  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Chills  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Fatigue  1  3/420 (0.71%)  0/52 (0.00%)  4/469 (0.85%) 
Feeling cold  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Malaise  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Non-cardiac chest pain  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Oedema peripheral  1  0/420 (0.00%)  1/52 (1.92%)  3/469 (0.64%) 
Immune system disorders       
Hypersensitivity  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Seasonal allergy  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Infections and infestations       
Abscess limb  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Bronchitis  1  6/420 (1.43%)  0/52 (0.00%)  2/469 (0.43%) 
Cellulitis  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Cutaneous larva migrans  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Cystitis  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Gastroenteritis viral  1  1/420 (0.24%)  1/52 (1.92%)  1/469 (0.21%) 
Influenza  1  3/420 (0.71%)  1/52 (1.92%)  2/469 (0.43%) 
Nasopharyngitis  1  8/420 (1.90%)  0/52 (0.00%)  13/469 (2.77%) 
Oral fungal infection  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Oral herpes  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Pharyngitis  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Pharyngitis streptococcal  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Pneumonia  1  2/420 (0.48%)  0/52 (0.00%)  1/469 (0.21%) 
Sinusitis  1  3/420 (0.71%)  0/52 (0.00%)  3/469 (0.64%) 
Tooth abscess  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Upper respiratory tract infection  1  4/420 (0.95%)  2/52 (3.85%)  10/469 (2.13%) 
Urinary tract infection  1  4/420 (0.95%)  0/52 (0.00%)  2/469 (0.43%) 
Viral infection  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Viral upper respiratory tract infection  1  3/420 (0.71%)  0/52 (0.00%)  0/469 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Contusion  1  1/420 (0.24%)  1/52 (1.92%)  0/469 (0.00%) 
Excoriation  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Fall  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Foot fracture  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Hand fracture  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Joint dislocation  1  0/420 (0.00%)  1/52 (1.92%)  0/469 (0.00%) 
Joint injury  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Joint sprain  1  1/420 (0.24%)  0/52 (0.00%)  2/469 (0.43%) 
Ligament rupture  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Limb injury  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Muscle strain  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Skin laceration  1  1/420 (0.24%)  0/52 (0.00%)  2/469 (0.43%) 
Soft tissue injury  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Tooth fracture  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Wound  1  0/420 (0.00%)  0/52 (0.00%)  2/469 (0.43%) 
Investigations       
Alanine aminotransferase increased  1  2/420 (0.48%)  0/52 (0.00%)  1/469 (0.21%) 
Aspartate aminotransferase increased  1  2/420 (0.48%)  0/52 (0.00%)  1/469 (0.21%) 
Blood alkaline phosphatase increased  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Blood creatinine abnormal  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Blood potassium increased  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Blood sodium decreased  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Blood sodium increased  1  1/420 (0.24%)  1/52 (1.92%)  2/469 (0.43%) 
Blood triglycerides increased  1  2/420 (0.48%)  0/52 (0.00%)  0/469 (0.00%) 
Blood uric acid increased  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Gamma-glutamyltransferase increased  1  4/420 (0.95%)  0/52 (0.00%)  0/469 (0.00%) 
Hepatic enzyme increased  1  2/420 (0.48%)  0/52 (0.00%)  1/469 (0.21%) 
Liver function test abnormal  1  2/420 (0.48%)  0/52 (0.00%)  0/469 (0.00%) 
Low density lipoprotein increased  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Lymphocyte morphology abnormal  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
Neutrophil count increased  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Protein total increased  1  0/420 (0.00%)  1/52 (1.92%)  0/469 (0.00%) 
Weight decreased  1  0/420 (0.00%)  0/52 (0.00%)  1/469 (0.21%) 
White blood cell count decreased  1  1/420 (0.24%)  0/52 (0.00%)  0/469 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/420 (0.24%)  0/52 (0.00%)  1/469 (0.21%) 
Dehydration  1