Efficacy and Safety of Azilsartan Medoxomil Combined With... | NCT00847626 | Trialant
NCT00847626
Sponsor
Takeda
Status
Completed
Last Update Posted
Feb 7, 2012Estimated
Enrollment
1,711Actual
Phase
Phase 3
Conditions
Hypertension
Interventions
Azilsartan medoxomil and chlorthalidone
Azilsartan medoxomil and chlorthalidone
Azilsartan medoxomil and chlorthalidone
Azilsartan medoxomil and chlorthalidone
Azilsartan medoxomil and chlorthalidone
Azilsartan medoxomil and chlorthalidone
Chlorthalidone
Chlorthalidone
Azilsartan medoxomil
Azilsartan medoxomil
Azilsartan medoxomil
Countries
United States
Chile
Mexico
Peru
Russia
Protocol Section
Identification Module
NCT ID
NCT00847626
Obsolete or Duplicate NCT IDs
NCT00892645
Organization Study
TAK-491CLD_302
Secondary IDs
ID
Type
Description
Link
2008-004218-28
EudraCT Number
U1111-1113-8735
Registry Identifier
WHO
Brief Title
Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension
Official Title
A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jan 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2009
Primary Completion Date
May 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Feb 18, 2009
First Submission Date that Met QC Criteria
Feb 18, 2009
First Posted Date
Feb 19, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 4, 2012
Results First Submitted that Met QC Criteria
Jan 4, 2012
Results First Posted Date
Feb 7, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 4, 2012
Last Update Posted Date
Feb 7, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe hypertension.
Detailed Description
According to the World Health Organization (WHO), 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. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully.
Although most antihypertensive agents are effective at the appropriate dose, the majority have side effects that limit their use. As a class, angiotensin II receptor blockers generally are considered more tolerable than other classes of antihypertensive agents. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker that is being evaluated by Takeda to treat essential hypertension.
Treatments for essential hypertension commonly include use of a thiazide-like diuretic, either alone or as part of combination treatment.
This study is designed to compare the antihypertensive effect and the safety and tolerability of the azilsartan medoxomil plus chlorthalidone fixed-dose combination product (TAK 491CLD FDC) with azilsartan monotherapy and chlorthalidone monotherapy during 8 weeks of treatment.
Participants in this study will be randomized to receive one of 11 possible dosing combinations of azilsartan medoxomil , chlorthalidone and placebo over an 8 week period. The total duration of the study will be approximately 13 weeks. Participants will make 12 visits to the clinic. Each participant will also be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.
Baseline and Week 8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on the day prior to randomization, or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on the day prior to randomization.
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.
Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.
Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if on amlodipine or chlorthalidone.
Exclusion Criteria:
Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on the day prior to randomization.
Has a baseline 24-hour ambulatory blood pressure measurement reading of insufficient quality.
Has works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]).
Has an upper arm circumference less than 24 cm or greater than 42 cm.
Has is noncompliant with study medication during the placebo run-in period.
Has secondary hypertension of any etiology.
Has recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects.
Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Has severe renal dysfunction or disease.
Has known or suspected unilateral or bilateral renal artery stenosis.
Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Has poorly controlled type 1 or type 2 diabetes mellitus at Screening.
Has hypokalemia or hyperkalemia.
Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow Has according to the protocol.
Has known hypersensitivity to angiotensin II receptor blockers, thiazide-type diuretics or other sulfonamide-derived compounds.
Has been randomized in a previous azilsartan medoxomil study.
Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to Screening.
Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Executive Medical Director
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Birmingham
Alabama
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants with moderate to severe essential hypertension were enrolled in one of 11, once-daily (QD) treatment groups.
Recruitment Details
Participants enrolled at 175 investigative sites in Austria, Chile, Germany, Guatemala, Mexico, Netherlands, Peru, Poland, Russian Federation and the United States from 29 January 2009 to 10 July 2010.
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Chlorthalidone 12.5 mg QD
Chlorthalidone
Drug
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Chlorthalidone 25 mg QD
Azilsartan medoxomil
Drug
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 20 mg QD
TAK-491CLD
Azilsartan medoxomil
Drug
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 40 mg QD
TAK-491CLD
Azilsartan medoxomil
Drug
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 80 mg QD
TAK-491CLD
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)
The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)
The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean systolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 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.
Baseline and Week 8.
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic systolic blood pressure measurements.
Baseline and Week 8
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic diastolic blood pressure measurements.
Baseline and Week 8.
Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.
Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
BG006
Chlorthalidone 12.5 mg QD
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
BG007
Chlorthalidone 25 mg QD
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
BG008
Azilsartan Medoxomil 20 mg QD
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
BG009
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
BG010
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000156
BG001154
BG002147
BG003156
BG004153
BG005162
BG006157
BG007159
BG008155
BG009153
BG010162
BG0111714
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.2± 10.57
BG00157.4± 11.13
BG00256.2± 10.50
BG003
Age, Customized
Number
participants
Title
Denominators
Categories
<45 years
Title
Measurements
BG00015
BG00116
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00086
BG00177
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG00119
BG002
Race (NIH/OMB)
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0009
BG00113
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Austria
Title
Measurements
BG0001
BG0010
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000166.3± 11.71
BG001166.6± 10.85
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00089.85± 22.076
BG00186.06± 18.056
BG002
Body Mass Index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00032.2± 5.73
BG00131.0± 5.65
BG002
Smoking Status
Number
participants
Title
Denominators
Categories
Never smoked
Title
Measurements
BG00094
BG00184
BG002
Estimated glomerular filtration rate (eGFR)
eGFR based on calculated creatinine clearance.
Categories:
Normal renal function (≥90 mL/min/1.73 m2) Mild renal impairment(60 to <90 mL/min/1.73 m2) Moderate renal impairment (30 to <60 mL/min/1.73 m2) Severe renal impairment (0 to <30 mL/min/1.73 m2)
Includes all randomized participants
Number
participants
Title
Denominators
Categories
≥0 and <30
Title
Measurements
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline and Week 8.
ID
Title
Description
OG000
Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OR
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG001
Chlorthalidone 25 mg QD
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG002
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
Units
Counts
Participants
OG000228
OG001134
OG002127
Title
Denominators
Categories
Title
Measurements
OG000-28.9± 0.89
OG001-15.9± 1.16
OG002-15.1± 1.19
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Net)
-13.0
2-Sided
95
-15.8
-9.5
No
Superiority or Other
Secondary
Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)
The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline and Week 8.
ID
Title
Description
OG000
Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OR
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG001
Chlorthalidone 25 mg QD
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG002
Azilsartan Medoxomil 80 mg QD
Secondary
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)
The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean systolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 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.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic systolic blood pressure measurements.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Secondary
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic diastolic blood pressure measurements.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.
Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.
Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.
Treatment-emergent adverse events are adverse events that started on or 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.
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.
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
2
161
67
161
EG006
Chlorthalidone 12.5 mg QD
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
0
156
51
156
EG007
Chlorthalidone 25 mg QD
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
2
160
53
160
EG008
Azilsartan Medoxomil 20 mg QD
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
2
155
25
155
EG009
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
2
153
36
153
EG010
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
3
162
32
162
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial ischaemia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG0030 affected156 at risk
EG0040 affected153 at risk
EG0050 affected161 at risk
EG0060 affected156 at risk
EG0070 affected160 at risk
EG0081 affected155 at risk
EG0091 affected153 at risk
EG0100 affected162 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Inguinal hernia strangulated
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Multi-organ failure
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Non-cardiac chest pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Endocarditis bacterial
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Gangrene
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Uterine infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Blood urea increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Heart rate increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Drop attacks
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0021 affected146 at risk
EG003
Radicular syndrome
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected156 at risk
EG0010 affected154 at risk
EG0020 affected146 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0008 affected156 at risk
EG0015 affected154 at risk
EG0022 affected146 at risk
EG0037 affected156 at risk
EG0042 affected153 at risk
EG0053 affected161 at risk
EG0066 affected156 at risk
EG0074 affected160 at risk
EG0082 affected155 at risk
EG0097 affected153 at risk
EG0102 affected162 at risk
Blood creatinine increased
Investigations
MedDRA 13.0
Systematic Assessment
EG00015 affected156 at risk
EG00119 affected154 at risk
EG00217 affected146 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0003 affected156 at risk
EG0014 affected154 at risk
EG0023 affected146 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0003 affected156 at risk
EG0019 affected154 at risk
EG0026 affected146 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0003 affected156 at risk
EG0012 affected154 at risk
EG0020 affected146 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG00012 affected156 at risk
EG00117 affected154 at risk
EG00220 affected146 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0008 affected156 at risk
EG00112 affected154 at risk
EG0021 affected146 at risk
EG003
Blood urea increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 affected156 at risk
EG0016 affected154 at risk
EG0024 affected146 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0002 affected156 at risk
EG0016 affected154 at risk
EG0024 affected146 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0008 affected156 at risk
EG0012 affected154 at risk
EG0020 affected146 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Point of Contact
Title
Organization
Phone
Extension
Email
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
800-778-2860
clinicaltrialregistry@tpna.com
ID
Term
D006973
Hypertension
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C557413
azilsartan medoxomil
D002752
Chlorthalidone
Ancestor Terms
ID
Term
D000096926
Benzenesulfonamides
D013449
Sulfonamides
D000577
Amides
D009930
Organic Chemicals
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D001577
Benzophenones
D010797
Phthalimides
D007094
Imides
D007659
Ketones
D013450
Sulfones
D013457
Sulfur Compounds
D054833
Isoindoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
0 subjects
FG0053 subjects
FG0061 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
12 subjects
FG0059 subjects
FG0068 subjects
FG0074 subjects
FG0084 subjects
FG0095 subjects
FG0102 subjects
2 subjects
FG0050 subjects
FG0066 subjects
FG0072 subjects
FG0085 subjects
FG0091 subjects
FG0107 subjects
2 subjects
FG0052 subjects
FG0062 subjects
FG0073 subjects
FG0081 subjects
FG0091 subjects
FG0103 subjects
57.4
± 11.07
BG00455.8± 11.22
BG00557.6± 11.04
BG00657.3± 11.30
BG00756.2± 10.04
BG00857.3± 11.04
BG00957.8± 10.28
BG01057.3± 10.87
BG01157.2± 10.82
17
BG00321
BG00425
BG00519
BG00621
BG00718
BG00818
BG00917
BG01016
BG011203
Between 45 to 64 years
Title
Measurements
BG00098
BG00197
BG002100
BG00393
BG00490
BG005104
BG00697
BG007108
BG00897
BG00998
BG010107
BG0111089
≥65 years
Title
Measurements
BG00043
BG00141
BG00230
BG00342
BG00438
BG00539
BG00639
BG00733
BG00840
BG00938
BG01039
BG011422
76
BG00385
BG00482
BG005100
BG00674
BG00790
BG00887
BG00968
BG01084
BG011909
Male
BG00070
BG00177
BG00271
BG00371
BG00471
BG00562
BG00683
BG00769
BG00868
BG00985
BG01078
BG011805
11
BG00315
BG00419
BG00515
BG00617
BG00719
BG00820
BG00917
BG01015
BG011177
Not Hispanic or Latino
BG00090
BG00175
BG00276
BG00385
BG00471
BG00587
BG00684
BG00786
BG00877
BG00980
BG01086
BG011897
Unknown or Not Reported
BG00056
BG00160
BG00260
BG00356
BG00463
BG00560
BG00656
BG00754
BG00858
BG00956
BG01061
BG011640
13
BG00313
BG00412
BG00516
BG00614
BG00714
BG00811
BG00913
BG01014
BG011142
Asian
Title
Measurements
BG0004
BG0013
BG0024
BG0034
BG0042
BG0053
BG0061
BG0077
BG0081
BG0091
BG0104
BG01134
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0112
Black or African American
Title
Measurements
BG00034
BG00128
BG00229
BG00330
BG00426
BG00534
BG00631
BG00729
BG00831
BG00935
BG01035
BG011342
White
Title
Measurements
BG000111
BG001112
BG002102
BG003111
BG004114
BG005109
BG006111
BG007111
BG008113
BG009105
BG010111
BG0111210
More than one race
Title
Measurements
BG0002
BG0012
BG0021
BG0032
BG0041
BG0050
BG0061
BG0072
BG0081
BG0091
BG0102
BG01115
Unknown or Not Reported
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
0
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0112
Chile
Title
Measurements
BG0003
BG0013
BG0023
BG0032
BG0042
BG0053
BG0062
BG0071
BG0082
BG0093
BG0102
BG01126
Germany
Title
Measurements
BG0004
BG0016
BG0026
BG0035
BG0046
BG0055
BG0064
BG0075
BG0083
BG0094
BG0105
BG01153
Guatemala
Title
Measurements
BG0008
BG0018
BG0029
BG00310
BG00410
BG0058
BG0068
BG0079
BG0088
BG0099
BG0109
BG01196
Mexico
Title
Measurements
BG00010
BG00111
BG00211
BG0039
BG00412
BG00511
BG00611
BG0078
BG00813
BG00911
BG01012
BG011119
Netherlands
Title
Measurements
BG0006
BG0017
BG0026
BG0035
BG0047
BG0055
BG0066
BG0076
BG0086
BG0096
BG0107
BG01167
Peru
Title
Measurements
BG00011
BG00112
BG00213
BG00312
BG00412
BG00514
BG00612
BG00711
BG00813
BG00912
BG01012
BG011134
Poland
Title
Measurements
BG0008
BG0018
BG0027
BG0038
BG0048
BG0058
BG0067
BG0078
BG0088
BG0097
BG0108
BG01185
Russian Federation
Title
Measurements
BG0005
BG0015
BG0025
BG0035
BG0045
BG0056
BG0066
BG0076
BG0085
BG0094
BG0106
BG01158
United States
Title
Measurements
BG000100
BG00194
BG00287
BG003100
BG00490
BG005102
BG006101
BG007105
BG00897
BG00997
BG010101
BG0111074
167.1
± 11.44
BG003166.8± 11.64
BG004166.6± 10.81
BG005165.4± 10.79
BG006168.3± 11.07
BG007166.1± 11.36
BG008166.4± 10.65
BG009167.7± 12.27
BG010167.1± 11.85
BG011166.8± 11.32
89.28
± 21.484
BG00390.16± 21.949
BG00487.31± 19.209
BG00586.44± 20.412
BG00689.12± 21.049
BG00786.70± 20.270
BG00887.27± 18.934
BG00987.54± 19.019
BG01086.27± 20.354
BG01187.80± 20.289
31.8
± 6.57
BG00332.2± 6.01
BG00431.4± 5.84
BG00531.5± 6.28
BG00631.2± 5.85
BG00731.2± 5.78
BG00831.3± 5.23
BG00931.0± 5.85
BG01030.8± 6.28
BG01131.4± 5.92
81
BG00379
BG00491
BG00594
BG00693
BG00791
BG00892
BG00990
BG01094
BG011983
Current smoker
Title
Measurements
BG00022
BG00128
BG00225
BG00335
BG00426
BG00528
BG00625
BG00729
BG00825
BG00931
BG01029
BG011303
Ex-smoker
Title
Measurements
BG00040
BG00142
BG00241
BG00342
BG00436
BG00540
BG00639
BG00739
BG00838
BG00932
BG01039
BG011428
0
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0111
≥30 and <60
Title
Measurements
BG00013
BG00114
BG0026
BG0038
BG0046
BG00510
BG00612
BG0079
BG00811
BG00911
BG0108
BG011108
≥60 and <90
Title
Measurements
BG00095
BG00190
BG00293
BG00397
BG004109
BG005110
BG006101
BG007100
BG00894
BG00995
BG01099
BG0111083
≥90
Title
Measurements
BG00048
BG00150
BG00248
BG00351
BG00438
BG00542
BG00644
BG00750
BG00849
BG00946
BG01055
BG011521
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0111
OG000
OG002
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG006
Chlorthalidone 12.5 mg QD
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
OG007
Chlorthalidone 25 mg QD
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OG008
Azilsartan Medoxomil 20 mg QD
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
OG009
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
OG010
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
Units
Counts
Participants
OG000154
OG001153
OG002145
OG003155
OG004151
OG005158
OG006155
OG007156
OG008155
OG009152
OG010162
Title
Denominators
Categories
Title
Measurements
OG000-33.8± 1.26
OG001-37.0± 1.26
OG002-36.8± 1.30
OG003-39.5± 1.25
OG004-36.9± 1.27
OG005-40.1± 1.24
OG006-21.1± 1.25
OG007-27.1± 1.25
OG008-19.8± 1.26
OG009-23.3± 1.27
OG010-24.2± 1.23
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-12.7
2-Sided
95
-16.2
-9.2
No
Superiority or Other
OG001
OG007
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-9.9
2-Sided
95
-13.4
-6.4
No
Superiority or Other
OG002
OG006
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-15.7
2-Sided
95
-19.2
-12.1
No
Superiority or Other
OG003
OG007
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-12.4
2-Sided
95
-15.8
-8.9
No
Superiority or Other
OG004
OG006
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-15.8
2-Sided
95
-19.3
-12.3
No
Superiority or Other
OG005
OG007
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-13.0
2-Sided
95
-16.5
-9.5
No
Superiority or Other
OG000
OG008
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-14.0
2-Sided
95
-17.5
-10.5
No
Superiority or Other
OG001
OG008
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-17.2
2-Sided
95
-20.6
-13.7
No
Superiority or Other
OG002
OG009
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-13.5
2-Sided
95
-17.0
-9.9
No
Superiority or Other
OG003
OG009
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-16.2
2-Sided
95
-19.7
-12.7
No
Superiority or Other
OG004
OG010
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-12.8
2-Sided
95
-16.3
-9.3
No
Superiority or Other
OG005
OG010
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-16.0
2-Sided
95
-19.4
-12.6
No
Superiority or Other
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
Units
Counts
Participants
OG00040
OG00122
OG00228
Title
Denominators
Categories
Title
Measurements
OG000-28.2± 2.49
OG001-23.4± 3.36
OG002-9.9± 2.97
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.
ANCOVA
0.255
Tested at 5% significance level.
Mean Difference (Final Values)
-4.8
2-Sided
95
-13.0
3.5
No
Superiority or Other
OG000
OG002
ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.
ANCOVA
<0.001
Tested at 5% significance level.
Mean Difference (Final Values)
-18.2
2-Sided
95
-25.9
-10.6
No
Superiority or Other
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.