Clincosm LogoSign in Get a demo

Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT00696241
Collaborator
(none)
1,275
Enrollment
85
Locations
5
Arms
16
Duration (Months)
15
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.

Condition or Disease Intervention/Treatment Phase
  • Drug: Azilsartan medoxomil and olmesartan
  • Drug: Azilsartan medoxomil and olmesartan
  • Drug: Azilsartan medoxomil and olmesartan
  • Drug: Olmesartan
  • Drug: Placebo
 Phase 3

Detailed Description

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.

TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker and this study is being conducted to evaluate the efficacy and safety of oral azilsartan medoxomil compared to placebo and olmesartan in subjects with essential hypertension.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting blood pressure and pulse, body height and weight, physical examinations and electrocardiograms. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Study Design

Study Type:
Interventional
Actual Enrollment :
1275 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azilsartan Medoxomil 20 mg QD

Drug: Azilsartan medoxomil and olmesartan
Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.
Other Names:
  • TAK-491
  • Edarbi

    		•
    Experimental: Azilsartan Medoxomil 40 mg QD

    Drug: Azilsartan medoxomil and olmesartan
    Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.
    Other Names:
  • TAK-491
  • Edarbi

    		•
    Experimental: Azilsartan Medoxomil 80 mg QD

    Drug: Azilsartan medoxomil and olmesartan
    Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
    Other Names:
  • TAK-491
  • Edarbi

    		•
    Active Comparator: Olmesartan 40 mg QD

    Drug: Olmesartan
    Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
    Other Names:
  • Benicar®

    		•
    Placebo Comparator: Placebo QD

    Drug: Placebo
    Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

    Secondary Outcome Measures

    1. Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure [Baseline and Week 6.]

      The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.

    2. Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

    3. Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure [Baseline and Week 6.]

      The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.

    4. Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

    5. Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

    6. Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

    7. Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

    8. Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring [Baseline and Week 6.]

      The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

    9. Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring [Baseline and Week 6.]

      The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

    10. Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

    11. Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. [Baseline and Week 6.]

      The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

    12. Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg [Baseline and Week 6.]

      Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

    13. Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg [Baseline and Week 6.]

      Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

    14. Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response [Baseline and Week 6.]

      Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.

    Eligibility Criteria

    Criteria

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

    Inclusion Criteria

    1. Has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day minus 1) and 24-hour mean systolic blood pressure greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg at Day 1).

    2. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

    3. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.

    4. The subject is willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to screening, the subject is willing to discontinue this medication at Screening Day minus 28.

    Exclusion Criteria

    1. Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1.

    2. Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.

    3. History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.

    4. Clinically significant cardiac conduction defects (eg, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter).

    5. Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.

    6. Secondary hypertension of any etiology.

    7. Is noncompliant (less than 70% or greater than 130%) with study medication during Placebo Run-In Period.

    8. Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.

    9. Known or suspected unilateral or bilateral renal artery stenosis.

    10. History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years.

    11. History of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those subjects with basal cell or stage I squamous cell carcinoma of the skin).

    12. Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.

    13. Alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.

    14. Hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening.

    15. Upper arm circumference less than 24 cm or greater than 42 cm.

    16. Works night (3rd) shift (defined as 11 PM to 7 AM).

    17. Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening.

    18. Any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.

    19. Randomized in a previous azilsartan medoxomil study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Huntsville Alabama United States
    3 Mesa Arizona United States
    4 Phoenix Arizona United States
    5 Tempe Arizona United States
    6 Little Rock Arkansas United States
    7 Tempe Arkansas United States
    8 Beverly Hills California United States
    9 Carmichael California United States
    10 Fountain Valley California United States
    11 Long Beach California United States
    12 Los Gatos California United States
    13 Orangevale California United States
    14 Sacramento California United States
    15 Santa Ana California United States
    16 Spring Valley California United States
    17 Tustin California United States
    18 Westlake Village California United States
    19 Colorado Springs Colorado United States
    20 Farmington Connecticut United States
    21 Hollywood Florida United States
    22 Jacksonville Florida United States
    23 Jupiter Florida United States
    24 Melbourne Florida United States
    25 Miami Florida United States
    26 Naples Florida United States
    27 Ocala Florida United States
    28 Pembroke Pines Florida United States
    29 Sarasota Florida United States
    30 St. Petersburg Florida United States
    31 Augusta Georgia United States
    32 Lawrenceville Georgia United States
    33 Chicago Illinois United States
    34 Melrose Park Illinois United States
    35 Naperville Illinois United States
    36 Round Lake Beach Illinois United States
    37 Valparaiso Indiana United States
    38 Wichita Kansas United States
    39 Erlanger Kentucky United States
    40 Lexington Kentucky United States
    41 Auburn Maine United States
    42 West Yarmouth Massachusetts United States
    43 Benzonia Michigan United States
    44 Chelsea Michigan United States
    45 Omaha Nebraska United States
    46 Trenton New Jersey United States
    47 Wildwood Crest New Jersey United States
    48 Albuquerque New Mexico United States
    49 Brooklyn New York United States
    50 Orangevale New York United States
    51 Rochester New York United States
    52 Burlington North Carolina United States
    53 Charlotte North Carolina United States
    54 Raleigh North Carolina United States
    55 Salisbury North Carolina United States
    56 Statesville North Carolina United States
    57 Wilmington North Carolina United States
    58 Winston-Salem North Carolina United States
    59 Kettering Ohio United States
    60 Lyndhurst Ohio United States
    61 Marion Ohio United States
    62 Norman Oklahoma United States
    63 Oklahoma City Oklahoma United States
    64 Altoona Pennsylvania United States
    65 Reading Pennsylvania United States
    66 Mt. Pleasant South Carolina United States
    67 Simpsonville South Carolina United States
    68 Taylors South Carolina United States
    69 Nashville Tennessee United States
    70 New Tazewell Tennessee United States
    71 Dallas Texas United States
    72 Houston Texas United States
    73 Lake Jackson Texas United States
    74 North Richland Hills Texas United States
    75 San Antonio Texas United States
    76 Draper Utah United States
    77 Burke Virginia United States
    78 Norfolk Virginia United States
    79 Tacoma Washington United States
    80 Madison Wisconsin United States
    81 Provincia de Buenos Aires Argentina
    82 Provincia de Cordoba Argentina
    83 Aguascalientes, Mexico
    84 Mexico DF Mexico
    85 San Luis Potosi Mexico

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: VP Clinical Science Strategy, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00696241
    Other Study ID Numbers:
    • 01-05-TL-491-008
    • U1111-1113-8905
    First Posted:
    Jun 12, 2008
    Last Update Posted:
    Jul 29, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Essential Hypertension
    Cardiovascular Disease
    High Blood Pressure
    Drug Therapy
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Olmesartan
    Olmesartan Medoxomil
    Azilsartan medoxomil

    Study Results

    Participant Flow

    Recruitment Details Participants enrolled at 147 investigative sites in Argentina, Mexico, Peru and the United States from 25 June 2007 to 08 October 2008.
    Pre-assignment Detail Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Period Title: Overall Study
    STARTED 283 283 285 282 142
    COMPLETED 259 261 261 268 130
    NOT COMPLETED 24 22 24 14 12

    Baseline Characteristics

    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD Total
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks. Total of all reporting groups
    Overall Participants 283 283 285 282 142 1275
    Age (participants) [Number]
    <45 years
    32
    11.3%
    29
    10.2%
    37
    13%
    32
    11.3%
    11
    7.7%
    141
    11.1%
    Between 45 and 64 years
    173
    61.1%
    187
    66.1%
    161
    56.5%
    153
    54.3%
    84
    59.2%
    758
    59.5%
    ≥65 years
    78
    27.6%
    67
    23.7%
    87
    30.5%
    97
    34.4%
    47
    33.1%
    376
    29.5%
    Sex: Female, Male (Count of Participants)
    Female
    150
    53%
    141
    49.8%
    136
    47.7%
    142
    50.4%
    66
    46.5%
    635
    49.8%
    Male
    133
    47%
    142
    50.2%
    149
    52.3%
    140
    49.6%
    76
    53.5%
    640
    50.2%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -12.15
    (0.709)
    -13.48
    (0.704)
    -14.62
    (0.706)
    -12.56
    (0.696)
    -1.40
    (1.004)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -10.75
    Confidence Interval () 95%
    -13.17 to -8.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.08
    Confidence Interval (2-Sided) 95%
    -14.48 to -9.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.21
    Confidence Interval (2-Sided) 95%
    -15.62 to -10.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.687
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.40
    Confidence Interval (2-Sided) 95%
    -1.55 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.352
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.92
    Confidence Interval (2-Sided) 95%
    -2.87 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.038
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.06
    Confidence Interval (2-Sided) 95%
    -4.00 to -0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
    Description The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 274 276 279 280 140
    Least Squares Mean (Standard Error) [mmHg]
    -14.28
    (0.956)
    -14.47
    (0.952)
    -17.58
    (0.947)
    -14.87
    (0.945)
    -2.06
    (1.337)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.23
    Confidence Interval (2-Sided) 95%
    -15.45 to -9.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.42
    Confidence Interval (2-Sided) 95%
    -15.64 to -9.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.53
    Confidence Interval (2-Sided) 95%
    -18.74 to -12.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.59
    Confidence Interval (2-Sided) 95%
    -2.05 to 3.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.768
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.40
    Confidence Interval (2-Sided) 95%
    -2.24 to 3.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.043
    Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.71
    Confidence Interval (2-Sided) 95%
    -5.34 to -0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -7.47
    (0.458)
    -8.38
    (0.455)
    -8.61
    (0.456)
    -7.74
    (0.449)
    -0.69
    (0.649)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.78
    Confidence Interval (2-Sided) 95%
    -8.34 to -5.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.68
    Confidence Interval (2-Sided) 95%
    -9.24 to -6.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.92
    Confidence Interval (2-Sided) 95%
    -9.47 to -6.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.679
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.27
    Confidence Interval (2-Sided) 95%
    -0.99 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.319
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -1.89 to 0.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.172
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -2.13 to 0.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
    Description The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 274 276 279 280 140
    Least Squares Mean (Standard Error) [mmHg]
    -6.82
    (0.535)
    -6.86
    (0.533)
    -8.42
    (0.530)
    -6.91
    (0.529)
    0.21
    (0.749)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.02
    Confidence Interval (2-Sided) 95%
    -8.83 to -5.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.07
    Confidence Interval (2-Sided) 95%
    -8.87 to -5.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.62
    Confidence Interval (2-Sided) 95%
    -10.42 to -6.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.908
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.09
    Confidence Interval (2-Sided) 95%
    -1.39 to 1.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.956
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -1.43 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.51
    Confidence Interval (2-Sided) 95%
    -2.98 to -0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -12.57
    (0.751)
    -13.75
    (0.746)
    -14.96
    (0.747)
    -12.73
    (0.737)
    -1.54
    (1.064)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.03
    Confidence Interval (2-Sided) 95%
    -13.59 to -8.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.20
    Confidence Interval (2-Sided) 95%
    -14.75 to -9.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.41
    Confidence Interval (2-Sided) 95%
    -15.97 to -10.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.879
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.16
    Confidence Interval (2-Sided) 95%
    -1.90 to 2.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.334
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.01
    Confidence Interval (2-Sided) 95%
    -3.07 to 1.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.22
    Confidence Interval (2-Sided) 95%
    -4.28 to -0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -7.71
    (0.490)
    -8.43
    (0.487)
    -8.87
    (0.488)
    -7.82
    (0.481)
    -0.59
    (0.695)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.12
    Confidence Interval (2-Sided) 95%
    -8.79 to -5.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.84
    Confidence Interval (2-Sided) 95%
    -9.51 to -6.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.28
    Confidence Interval (2-Sided) 95%
    -9.94 to -6.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.877
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.11
    Confidence Interval (2-Sided) 95%
    -1.24 to 1.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.369
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.62
    Confidence Interval (2-Sided) 95%
    -1.96 to 0.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.126
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.05
    Confidence Interval (2-Sided) 95%
    -2.39 to 0.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -11.10
    (0.781)
    -12.39
    (0.775)
    -13.35
    (0.777)
    -12.13
    (0.766)
    -0.97
    (1.105)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -10.13
    Confidence Interval (2-Sided) 95%
    -12.79 to -7.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.43
    Confidence Interval (2-Sided) 95%
    -14.07 to -8.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.38
    Confidence Interval (2-Sided) 95%
    -15.03 to -9.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.346
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    -1.12 to 3.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.811
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -2.40 to 1.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.267
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.21
    Confidence Interval (2-Sided) 95%
    -3.35 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -6.98
    (0.533)
    -7.90
    (0.530)
    -7.79
    (0.531)
    -7.62
    (0.523)
    -0.96
    (0.755)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.03
    Confidence Interval (2-Sided) 95%
    -7.84 to -4.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.94
    Confidence Interval (2-Sided) 95%
    -8.75 to -5.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.84
    Confidence Interval (2-Sided) 95%
    -8.65 to -5.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.394
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.64
    Confidence Interval (2-Sided) 95%
    -0.83 to 2.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.712
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.27
    Confidence Interval (2-Sided) 95%
    -1.74 to 1.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.818
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -1.63 to 1.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
    Description The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -12.72
    (0.795)
    -14.05
    (0.790)
    -15.18
    (0.791)
    -13.07
    (0.780)
    -1.36
    (1.126)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.35
    Confidence Interval (2-Sided) 95%
    -14.05 to -8.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.68
    Confidence Interval (2-Sided) 95%
    -15.38 to -9.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.81
    Confidence Interval (2-Sided) 95%
    -16.51 to -11.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.750
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.35
    Confidence Interval (2-Sided) 95%
    -1.83 to 2.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.378
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.98
    Confidence Interval (2-Sided) 95%
    -3.16 to 1.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.059
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.10
    Confidence Interval (2-Sided) 95%
    -4.28 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
    Description The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 243 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -7.72
    (0.519)
    -8.63
    (0.516)
    -8.88
    (0.517)
    -7.86
    (0.510)
    -0.47
    (0.736)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.25
    Confidence Interval (2-Sided) 95%
    -9.02 to -5.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.16
    Confidence Interval (2-Sided) 95%
    -9.92 to -6.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.41
    Confidence Interval (2-Sided) 95%
    -10.17 to -6.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.845
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.14
    Confidence Interval (2-Sided) 95%
    -1.29 to 1.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.290
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.77
    Confidence Interval (2-Sided) 95%
    -2.19 to 0.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.161
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.02
    Confidence Interval (2-Sided) 95%
    -2.44 to 0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 242 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -12.15
    (0.864)
    -12.39
    (0.858)
    -13.42
    (0.862)
    -11.10
    (0.848)
    -1.21
    (1.224)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -10.94
    Confidence Interval (2-Sided) 95%
    -13.88 to -8.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.18
    Confidence Interval (2-Sided) 95%
    -14.11 to -8.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -12.21
    Confidence Interval (2-Sided) 95%
    -15.15 to -9.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.385
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.05
    Confidence Interval (2-Sided) 95%
    -3.43 to 1.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.285
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.29
    Confidence Interval (2-Sided) 95%
    -3.66 to 1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.054
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.33
    Confidence Interval (2-Sided) 95%
    -4.70 to 0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
    Description The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 241 244 242 250 120
    Least Squares Mean (Standard Error) [mmHg]
    -7.96
    (0.614)
    -7.93
    (0.610)
    -8.68
    (0.612)
    -7.56
    (0.603)
    -1.12
    (0.870)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.84
    Confidence Interval (2-Sided) 95%
    -8.93 to -4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.80
    Confidence Interval (2-Sided) 95%
    -8.89 to -4.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.55
    Confidence Interval (2-Sided) 95%
    -9.64 to -5.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.642
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -2.09 to 1.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.672
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.36
    Confidence Interval (2-Sided) 95%
    -2.05 to 1.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.196
    Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.11
    Confidence Interval (2-Sided) 95%
    -2.80 to 0.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
    Description Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 274 276 279 281 140
    Number [percentage of participants]
    47.8
    16.9%
    50.4
    17.8%
    56.6
    19.9%
    53.2
    18.9%
    17.1
    12%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.48
    Confidence Interval (2-Sided) 95%
    2.71 to 7.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.97
    Confidence Interval (2-Sided) 95%
    3.01 to 8.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.53
    Confidence Interval (2-Sided) 95%
    3.95 to 10.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.173
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.57 to 1.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.449
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.63 to 1.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.402
    Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.83 to 1.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
    Description Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 274 276 279 281 140
    Number [percentage of participants]
    67.5
    23.9%
    71.0
    25.1%
    73.5
    25.8%
    73.9
    26.2%
    47.9
    33.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.86
    Confidence Interval (2-Sided) 95%
    1.82 to 4.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    2.15 to 5.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.81
    Confidence Interval (2-Sided) 95%
    2.41 to 6.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.177
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.76
    Confidence Interval (2-Sided) 95%
    0.52 to 1.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.628
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.61 to 1.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.928
    Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.68 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
    Description Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
    Time Frame Baseline and Week 6.

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with last observation carried forward.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    Measure Participants 274 276 279 281 140
    Number [percentage of participants]
    42.7
    15.1%
    45.3
    16%
    52.0
    18.2%
    47.5
    16.8%
    14.3
    10.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.53
    Confidence Interval (2-Sided) 95%
    2.66 to 7.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.04
    Confidence Interval (2-Sided) 95%
    2.96 to 8.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.75
    Confidence Interval (2-Sided) 95%
    3.96 to 11.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.217
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.81
    Confidence Interval (2-Sided) 95%
    0.58 to 1.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.537
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.64 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.276
    Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.86 to 1.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
    Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
    All Cause Mortality
    Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/283 (2.8%) 0/281 (0%) 1/284 (0.4%) 2/282 (0.7%) 3/142 (2.1%)
    Cardiac disorders
    Atrial fibrillation 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Coronary artery disease 0/283 (0%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 1/142 (0.7%)
    Myocardial infarction 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Gastrointestinal disorders
    Gastrointestinal haemorrhage 0/283 (0%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Inguinal hernia 0/283 (0%) 0/281 (0%) 0/284 (0%) 1/282 (0.4%) 0/142 (0%)
    General disorders
    Chest pain 0/283 (0%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 1/142 (0.7%)
    Hepatobiliary disorders
    Cholecystitis chronic 0/283 (0%) 0/281 (0%) 0/284 (0%) 1/282 (0.4%) 0/142 (0%)
    Infections and infestations
    Cellulitis 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Lower respiratory tract infection 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Pneumonia 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Nervous system disorders
    Epilepsy 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Ischaemic stroke 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Transient ischaemic attack 0/283 (0%) 0/281 (0%) 1/284 (0.4%) 0/282 (0%) 0/142 (0%)
    Respiratory, thoracic and mediastinal disorders
    Status asthmaticus 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Vascular disorders
    Ischaemia 0/283 (0%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 1/142 (0.7%)
    Shock 1/283 (0.4%) 0/281 (0%) 0/284 (0%) 0/282 (0%) 0/142 (0%)
    Other (Not Including Serious) Adverse Events
    Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 23/283 (8.1%) 19/281 (6.8%) 32/284 (11.3%) 18/282 (6.4%) 13/142 (9.2%)
    Metabolism and nutrition disorders
    Dyslipidemia 10/283 (3.5%) 11/281 (3.9%) 16/284 (5.6%) 10/282 (3.5%) 3/142 (2.1%)
    Nervous system disorders
    Headache 13/283 (4.6%) 9/281 (3.2%) 16/284 (5.6%) 9/282 (3.2%) 10/142 (7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.

    Results Point of Contact

    Name/Title Sr. VP, Clinical Science
    Organization Takeda Global Research and Development Center, Inc.
    Phone 800-778-2860
    Email clinicaltrialregistry@tpna.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00696241
    Other Study ID Numbers:
    • 01-05-TL-491-008
    • U1111-1113-8905
    First Posted:
    Jun 12, 2008
    Last Update Posted:
    Jul 29, 2011
    Last Verified:
    Jul 1, 2011