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Olmesartan Comparison to Losartan in Hypertensive Subjects

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00949884
Collaborator
(none)
941
Enrollment
20
Locations
3
Arms
5
Duration (Months)
47.1
Patients Per Site
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

Condition or Disease Intervention/Treatment Phase
  • Drug: olmesartan medoxomil
  • Drug: Placebo
  • Drug: losartan potassium
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
941 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Olmesartan

Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.

Drug: olmesartan medoxomil
Oral tablets, once daily, at either 20mg or 40mg daily.
Other Names:
  • Benicar
  • Olmetec

    		•
    Placebo Comparator: Placebo followed by Olmesartan

    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

    Drug: olmesartan medoxomil
    Oral tablets, once daily, at either 20mg or 40mg daily.
    Other Names:
  • Benicar
  • Olmetec

    • Drug: Placebo
    placebo oral tablets once daily for two weeks
    Active Comparator: Losartan

    Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

    Drug: losartan potassium
    losartan potassium oral tablet at either 50mg or 100 mg daily dose.
    Other Names:
  • Cozaar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [Day 0, Week 8]

      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.

    Secondary Outcome Measures

    1. Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [Day 0, Week 4]

      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.

    2. Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [Day 0, Week 8]

      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.

    3. Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [Day 0, Week 4]

      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.

    Other Outcome Measures

    1. Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [Week 4, Week 8]

      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.

    2. Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [Week 4, Week 8]

      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.

    3. Percentage of Participants Achieving Blood Pressure Goals at Week 4 [Week 4]

      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

    4. Percentage of Participants Achieving Blood Pressure Goals at Week 8 [Week 8]

      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

    5. Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 [Baseline, Week 4]

      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.

    6. Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 [Baseline, Week 8]

      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.

    7. Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 [Baseline, Week 4]

      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.

    8. Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 [Baseline, Week 8]

      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.

    9. Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 [Baseline, Week 4]

      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.

    10. Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 [Baseline, Week 8]

      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.

    11. Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure [Baseline, Week 2]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males or females aged > 18 years who are not institutionalized and have signed informed consent.

    • Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.

    • The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

    Exclusion Criteria:

    • Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.

    • Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.

    • Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.

    • Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.

    • Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.

    • Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mesa Arizona United States 85213
    2 Phoenix Arizona United States 85050
    3 Harbor City California United States 90710
    4 Tustin California United States 92780
    5 Westlake Village California United States 91361
    6 Pueblo Colorado United States 81001
    7 Deerfield Beach Florida United States 33442
    8 DeLand Florida United States 32720
    9 South Bend Indiana United States 46614
    10 Wichita Kansas United States 67205
    11 Metairie Louisiana United States 70006
    12 Albuquerque New Mexico United States 87108
    13 Binghamton New York United States 13701
    14 Charlotte North Carolina United States 28209
    15 Cincinnati Ohio United States 45219
    16 Greenville South Carolina United States 29615
    17 Bristol Tennessee United States 37620
    18 New Tazewell Tennessee United States 37825
    19 Dallas Texas United States 75230
    20 Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00949884
    Other Study ID Numbers:
    • CS0866-A-U452
    First Posted:
    Jul 30, 2009
    Last Update Posted:
    Mar 9, 2011
    Last Verified:
    Mar 1, 2011
    Additional relevant MeSH terms:
    Hypertension
    Losartan
    Olmesartan
    Olmesartan Medoxomil

    Study Results

    Participant Flow

    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 Detail 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
    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

    Baseline Characteristics

    Arm/Group Title Olmesartan Placebo Followed by Olmesartan Losartan Total
    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 Participants 420 52 469 941
    Age (Count of Participants)
    <=18 years
    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 (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.0
    (9.84)
    49.9
    (8.67)
    52.1
    (9.76)
    51.9
    (9.74)
    Sex: Female, Male (Count of Participants)
    Female
    190
    45.2%
    27
    51.9%
    211
    45%
    428
    45.5%
    Male
    230
    54.8%
    25
    48.1%
    258
    55%
    513
    54.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    52
    12.4%
    7
    13.5%
    61
    13%
    120
    12.8%
    Not Hispanic or Latino
    368
    87.6%
    45
    86.5%
    408
    87%
    821
    87.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    4
    1%
    0
    0%
    2
    0.4%
    6
    0.6%
    Asian
    25
    6%
    2
    3.8%
    26
    5.5%
    53
    5.6%
    Native Hawaiian or Other Pacific Islander
    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%
    33
    63.5%
    304
    64.8%
    610
    64.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    1.9%
    2
    0.4%
    3
    0.3%
    Hypertension stage (participants) [Number]
    Stage I
    120
    28.6%
    23
    44.2%
    134
    28.6%
    277
    29.4%
    Stage II
    300
    71.4%
    29
    55.8%
    335
    71.4%
    664
    70.6%
    Height (centimeter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeter]
    169.92
    (9.635)
    169.46
    (9.652)
    170.47
    (9.906)
    170.17
    (9.767)
    Weight (kilogram) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram]
    93.73
    (19.627)
    96.14
    (22.611)
    94.02
    (21.647)
    94.01
    (20.810)
    Body Mass Index (kilogram/meter^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram/meter^2]
    32.41
    (6.089)
    33.62
    (8.103)
    32.28
    (6.619)
    32.41
    (6.480)
    Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    158.3
    (10.41)
    157.9
    (10.05)
    158.3
    (10.24)
    158.3
    (10.29)
    Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    101.1
    (4.07)
    100.8
    (3.79)
    101.3
    (4.14)
    101.2
    (4.09)
    Pulse Rate (beats per minute) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [beats per minute]
    78.8
    (11.41)
    81.9
    (9.88)
    78.5
    (10.59)
    78.9
    (10.94)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 384 424 426
    Least Squares Mean (Standard Error) [mmHg]
    -9.8
    (0.50)
    -9.7
    (0.45)
    -7.1
    (0.45)
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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
    2. Secondary Outcome
    Title Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 417 461 461
    Least Squares Mean (Standard Error) [mmHg]
    -12.3
    (0.67)
    -12.0
    (0.64)
    -8.5
    (0.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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
    3. Secondary Outcome
    Title Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 384 424 426
    Least Squares Mean (Standard Error) [mmHg]
    -13.6
    (0.75)
    -13.6
    (0.71)
    -9.7
    (0.71)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    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
    4. Secondary Outcome
    Title Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 417 461 461
    Least Squares Mean (Standard Error) [mmHg]
    -9.0
    (0.44)
    -8.8
    (0.42)
    -6.2
    (0.42)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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
    5. Post-Hoc Outcome
    Title Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8
    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

    Outcome Measure Data

    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
    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
    Measure Participants 98 106 110
    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
    6. Other Pre-specified Outcome
    Title Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 384 424 426
    Least Squares Mean (Standard Error) [mmHg]
    -0.8
    (0.40)
    -0.9
    (0.38)
    0.0
    (0.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1121
    Comments
    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
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0783
    Comments
    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
    7. Other Pre-specified Outcome
    Title Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 384 424 426
    Least Squares Mean (Standard Error) [mmHg]
    -1.1
    (0.66)
    -1.4
    (0.63)
    0.0
    (0.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2312
    Comments
    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
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan, Losartan
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0979
    Comments
    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
    8. Other Pre-specified Outcome
    Title Percentage of Participants Achieving Blood Pressure Goals at Week 4
    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

    Outcome Measure Data

    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
    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
    Measure Participants 417 461 461
    Systolic BP <140 mmHg
    37.9
    9%
    36.7
    70.6%
    25.6
    5.5%
    Systolic BP <135 mmHg
    28.1
    6.7%
    27.1
    52.1%
    14.1
    3%
    Systolic BP <130 mmHg
    16.8
    4%
    16.5
    31.7%
    7.2
    1.5%
    Systolic BP <120 mmHg
    3.1
    0.7%
    3.5
    6.7%
    2.0
    0.4%
    Diastolic BP <90 mmHg
    39.6
    9.4%
    38.8
    74.6%
    24.5
    5.2%
    Diastolic BP <85 mmHg
    24.2
    5.8%
    23.9
    46%
    13.0
    2.8%
    Diastolic BP <80 mmHg
    10.6
    2.5%
    10.4
    20%
    4.6
    1%
    Blood pressure <140/90 mmHg
    27.3
    6.5%
    26.5
    51%
    14.3
    3%
    Blood pressure <135/80 mmHg
    7.4
    1.8%
    7.6
    14.6%
    2.2
    0.5%
    Blood pressure <130/80 mmHg
    5.5
    1.3%
    5.9
    11.3%
    1.5
    0.3%
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.2755
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.1646
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    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
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0010
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0023
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0012
    Comments
    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 Percentage of Participants Achieving Blood Pressure Goals at Week 8
    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

    Outcome Measure Data

    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
    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
    Measure Participants 384 424 426
    Systolic BP <140 mmHg
    41.1
    9.8%
    41.0
    78.8%
    28.9
    6.2%
    Systolic BP <135 mmHg
    29.9
    7.1%
    30.0
    57.7%
    20.4
    4.3%
    Systolic BP <130 mmHg
    18.2
    4.3%
    18.4
    35.4%
    13.1
    2.8%
    Systolic BP <120 mmHg
    6.8
    1.6%
    6.6
    12.7%
    3.8
    0.8%
    Diastolic BP <90 mmHg
    43.2
    10.3%
    42.5
    81.7%
    30.5
    6.5%
    Diastolic BP <85 mmHg
    22.9
    5.5%
    22.9
    44%
    15.5
    3.3%
    Diastolic BP <80 mmHg
    12.2
    2.9%
    11.8
    22.7%
    6.6
    1.4%
    Blood pressure <140/90 mmHg
    32.6
    7.8%
    31.6
    60.8%
    19.5
    4.2%
    Blood pressure <135/80 mmHg
    10.2
    2.4%
    9.9
    19%
    4.9
    1%
    Blood pressure <130/80 mmHg
    7.6
    1.8%
    7.5
    14.4%
    4.5
    1%
    Blood pressure <120/80 mmHg
    4.9
    1.2%
    4.7
    9%
    2.3
    0.5%
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0347
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0280
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0519
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0605
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0070
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0066
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0061
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0096
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0047
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0063
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0589
    Comments
    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
    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
    Statistical Test of Hypothesis p-Value 0.0594
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0476
    Comments
    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.
    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
    Statistical Test of Hypothesis p-Value 0.0657
    Comments
    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.
    10. Other Pre-specified Outcome
    Title Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4
    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

    Outcome Measure Data

    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
    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
    Measure Participants 108 118 118
    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)
    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
    Statistical Test of Hypothesis p-Value 0.3250
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.3491
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2085
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2542
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Other Pre-specified Outcome
    Title Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8
    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

    Outcome Measure Data

    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
    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
    Measure Participants 98 106 110
    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)
    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
    Statistical Test of Hypothesis p-Value 0.0209
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0186
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0175
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0177
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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 4
    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

    Outcome Measure Data

    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
    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
    Measure Participants 108 118 118
    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)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Daytime systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3104
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.3653
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Daytime diastolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1197
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1654
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Nighttime systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4362
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.4039
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Nighttime diastolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3929
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.4259
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. 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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 98 106 110
    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)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Daytime systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0396
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0345
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Daytime diastolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0324
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0363
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Nighttime systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0988
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Combined Olmesartan
    Comments Nighttime systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0926
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Losartan
    Comments Nighttime diastolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0900
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0942
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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 4
    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

    Outcome Measure Data

    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
    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
    Measure Participants 108 118 118
    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)
    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
    Statistical Test of Hypothesis p-Value 0.3229
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.3863
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1277
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1799
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2708
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.3133
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1621
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2314
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2461
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2558
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1700
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2011
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. 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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 98 106 110
    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)
    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
    Statistical Test of Hypothesis p-Value 0.1895
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.2701
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1328
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1778
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0620
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.1011
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0249
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0497
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0552
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0767
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0279
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    Statistical Test of Hypothesis p-Value 0.0434
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Other Pre-specified Outcome
    Title Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure
    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

    Outcome Measure Data

    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
    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
    Measure Participants 417 50 0
    Diastolic blood pressure
    -8.3
    (0.42)
    -4.0
    (1.22)
    Systolic blood pressure
    -11.9
    (0.65)
    -3.3
    (1.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Combined Olmesartan
    Comments Diastolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Olmesartan, Combined Olmesartan
    Comments Systolic blood pressure
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    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
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Olmesartan Placebo Followed by Olmesartan Losartan
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/420 (0%) 0/52 (0%) 4/469 (0.9%)
    General disorders
    Non-cardiac chest pain 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Infections and infestations
    Urinary tract infection 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Nervous system disorders
    Cerebrovasular accident 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Other (Not Including Serious) Adverse Events
    Olmesartan Placebo Followed by Olmesartan Losartan
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 133/420 (31.7%) 21/52 (40.4%) 148/469 (31.6%)
    Blood and lymphatic system disorders
    Anaemia 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Iron deficiency anaemia 0/420 (0%) 1/52 (1.9%) 0/469 (0%)
    Cardiac disorders
    Palpitations 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Tachycardia 1/420 (0.2%) 0/52 (0%) 4/469 (0.9%)
    Congenital, familial and genetic disorders
    Type II hyperlipidaemia 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Ear and labyrinth disorders
    Ear discomfort 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Ear pain 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Hypoacusis 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Tinnitus 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Endocrine disorders
    Hypothyroidism 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Eye disorders
    Conjunctivitis 1/420 (0.2%) 0/52 (0%) 3/469 (0.6%)
    Diplopia 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Eye pruritus 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Eye swelling 0/420 (0%) 1/52 (1.9%) 0/469 (0%)
    Vision blurred 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Gastrointestinal disorders
    Abdominal discomfort 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Abdominal distension 1/420 (0.2%) 0/52 (0%) 2/469 (0.4%)
    Abdominal pain lower 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Constipation 5/420 (1.2%) 1/52 (1.9%) 4/469 (0.9%)
    Diarrhoea 5/420 (1.2%) 1/52 (1.9%) 3/469 (0.6%)
    Dyspepsia 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Dysphagia 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Flatulence 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Gastrooesophageal reflux disease 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Inguinal hernia 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Lip swelling 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Nausea 7/420 (1.7%) 2/52 (3.8%) 9/469 (1.9%)
    Proctitis ulcerative 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Toothache 1/420 (0.2%) 1/52 (1.9%) 2/469 (0.4%)
    Vomiting 0/420 (0%) 0/52 (0%) 3/469 (0.6%)
    General disorders
    Asthenia 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Chest discomfort 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Chest pain 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Chills 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Fatigue 3/420 (0.7%) 0/52 (0%) 4/469 (0.9%)
    Feeling cold 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Malaise 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Non-cardiac chest pain 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Oedema peripheral 0/420 (0%) 1/52 (1.9%) 3/469 (0.6%)
    Immune system disorders
    Hypersensitivity 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Seasonal allergy 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Infections and infestations
    Abscess limb 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Bronchitis 6/420 (1.4%) 0/52 (0%) 2/469 (0.4%)
    Cellulitis 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Cutaneous larva migrans 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Cystitis 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Gastroenteritis viral 1/420 (0.2%) 1/52 (1.9%) 1/469 (0.2%)
    Influenza 3/420 (0.7%) 1/52 (1.9%) 2/469 (0.4%)
    Nasopharyngitis 8/420 (1.9%) 0/52 (0%) 13/469 (2.8%)
    Oral fungal infection 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Oral herpes 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Pharyngitis 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Pharyngitis streptococcal 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Pneumonia 2/420 (0.5%) 0/52 (0%) 1/469 (0.2%)
    Sinusitis 3/420 (0.7%) 0/52 (0%) 3/469 (0.6%)
    Tooth abscess 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Upper respiratory tract infection 4/420 (1%) 2/52 (3.8%) 10/469 (2.1%)
    Urinary tract infection 4/420 (1%) 0/52 (0%) 2/469 (0.4%)
    Viral infection 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Viral upper respiratory tract infection 3/420 (0.7%) 0/52 (0%) 0/469 (0%)
    Injury, poisoning and procedural complications
    Ankle fracture 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Contusion 1/420 (0.2%) 1/52 (1.9%) 0/469 (0%)
    Excoriation 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Fall 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Foot fracture 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Hand fracture 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Joint dislocation 0/420 (0%) 1/52 (1.9%) 0/469 (0%)
    Joint injury 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Joint sprain 1/420 (0.2%) 0/52 (0%) 2/469 (0.4%)
    Ligament rupture 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Limb injury 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Muscle strain 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Skin laceration 1/420 (0.2%) 0/52 (0%) 2/469 (0.4%)
    Soft tissue injury 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Tooth fracture 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Wound 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Investigations
    Alanine aminotransferase increased 2/420 (0.5%) 0/52 (0%) 1/469 (0.2%)
    Aspartate aminotransferase increased 2/420 (0.5%) 0/52 (0%) 1/469 (0.2%)
    Blood alkaline phosphatase increased 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Blood creatinine abnormal 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Blood potassium increased 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Blood sodium decreased 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Blood sodium increased 1/420 (0.2%) 1/52 (1.9%) 2/469 (0.4%)
    Blood triglycerides increased 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Blood uric acid increased 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Gamma-glutamyltransferase increased 4/420 (1%) 0/52 (0%) 0/469 (0%)
    Hepatic enzyme increased 2/420 (0.5%) 0/52 (0%) 1/469 (0.2%)
    Liver function test abnormal 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Low density lipoprotein increased 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Lymphocyte morphology abnormal 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Neutrophil count increased 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Protein total increased 0/420 (0%) 1/52 (1.9%) 0/469 (0%)
    Weight decreased 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    White blood cell count decreased 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Dehydration 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Gout 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Hypercholesterolaemia 3/420 (0.7%) 0/52 (0%) 0/469 (0%)
    Hypertriglyceridaemia 1/420 (0.2%) 0/52 (0%) 2/469 (0.4%)
    Increased appetite 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Vitamin D deficiency 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/420 (0.7%) 0/52 (0%) 1/469 (0.2%)
    Arthritis 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Back pain 4/420 (1%) 2/52 (3.8%) 3/469 (0.6%)
    Bursitis 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Gouty arthritis 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Muscle fatigue 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Muscle spasms 5/420 (1.2%) 0/52 (0%) 2/469 (0.4%)
    Muscle tightness 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Musculoskeletal chest pain 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Musculoskeletal stiffness 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Myalgia 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Neck pain 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Pain in extremity 3/420 (0.7%) 0/52 (0%) 2/469 (0.4%)
    Rotator cuff syndrome 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Temporomandibular joint syndrome 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Tendonitis 0/420 (0%) 1/52 (1.9%) 0/469 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Nervous system disorders
    Cerebrovascular accident 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Dizziness 8/420 (1.9%) 1/52 (1.9%) 6/469 (1.3%)
    Headache 18/420 (4.3%) 5/52 (9.6%) 24/469 (5.1%)
    Hypoaesthesia 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Migraine 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Nerve compression 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Paraesthesia 1/420 (0.2%) 0/52 (0%) 3/469 (0.6%)
    Peroneal nerve palsy 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Sinus headache 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Somnolence 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Tension headache 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Psychiatric disorders
    Anxiety 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Dysthymic disorder 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Insomnia 1/420 (0.2%) 0/52 (0%) 4/469 (0.9%)
    Nervousness 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Renal and urinary disorders
    Haematuria 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Nephrolithiasis 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Pollakiuria 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Proteinuria 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Reproductive system and breast disorders
    Vaginal haemorrhage 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Chronic obstructive pulmonary disease 0/420 (0%) 0/52 (0%) 2/469 (0.4%)
    Cough 3/420 (0.7%) 0/52 (0%) 4/469 (0.9%)
    Epistaxis 0/420 (0%) 0/52 (0%) 3/469 (0.6%)
    Nasal congestion 0/420 (0%) 0/52 (0%) 4/469 (0.9%)
    Oropharyngeal pain 0/420 (0%) 0/52 (0%) 4/469 (0.9%)
    Paranasal sinus hypersecretion 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Respiratory tract congestion 2/420 (0.5%) 0/52 (0%) 2/469 (0.4%)
    Rhinitis allergic 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Rhinorrhoea 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Sinus congestion 4/420 (1%) 0/52 (0%) 3/469 (0.6%)
    Upper respiratory tract congestion 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Wheezing 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Skin and subcutaneous tissue disorders
    Actinic keratosis 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Dermatitis contact 0/420 (0%) 1/52 (1.9%) 1/469 (0.2%)
    Ecchymosis 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Hyperhidrosis 2/420 (0.5%) 0/52 (0%) 0/469 (0%)
    Night sweats 1/420 (0.2%) 0/52 (0%) 1/469 (0.2%)
    Rash 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Rash papular 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Rash pruritic 0/420 (0%) 0/52 (0%) 1/469 (0.2%)
    Skin odour abnormal 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Surgical and medical procedures
    Sinus operation 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Tooth extraction 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Vascular disorders
    Hot flush 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Hypertension 3/420 (0.7%) 1/52 (1.9%) 4/469 (0.9%)
    Orthostatic hypotension 1/420 (0.2%) 0/52 (0%) 0/469 (0%)
    Venous insufficiency 1/420 (0.2%) 0/52 (0%) 0/469 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by DSI, any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."

    Results Point of Contact

    Name/Title Robert Dubiel, PharmD
    Organization Daiichi Sankyo, Inc.
    Phone 973-944-2963
    Email bdubiel@dsi.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00949884
    Other Study ID Numbers:
    • CS0866-A-U452
    First Posted:
    Jul 30, 2009
    Last Update Posted:
    Mar 9, 2011
    Last Verified:
    Mar 1, 2011