Trial Outcomes & Findings for Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension (NCT NCT00591773)
NCT ID: NCT00591773
Last Updated: 2011-04-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
551 participants
Primary outcome timeframe
Baseline and Week 6.
Results posted on
2011-04-19
Participant Flow
Participants enrolled at 74 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 07 September 2007 to 05 March 2009.
Participants with uncontrolled essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
182
|
184
|
|
Overall Study
COMPLETED
|
169
|
158
|
168
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
16
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
9
|
6
|
|
Overall Study
Protocol Violation
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
|
Overall Study
Other
|
1
|
1
|
4
|
Baseline Characteristics
Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=185 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=182 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=184 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Total
n=551 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Categorical
<45 years
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Age Categorical
Between 45 and 64 years
|
114 participants
n=5 Participants
|
110 participants
n=7 Participants
|
113 participants
n=5 Participants
|
337 participants
n=4 Participants
|
|
Age Categorical
≥65 years
|
50 participants
n=5 Participants
|
57 participants
n=7 Participants
|
55 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
285 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-31.30 mmHg
Standard Error 0.973
|
-15.85 mmHg
Standard Error 0.957
|
-31.72 mmHg
Standard Error 0.966
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=176 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=178 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=179 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
|
-34.44 mmHg
Standard Error 1.236
|
-21.76 mmHg
Standard Error 1.229
|
-36.16 mmHg
Standard Error 1.226
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-18.49 mmHg
Standard Error 0.630
|
-7.99 mmHg
Standard Error 0.619
|
-18.28 mmHg
Standard Error 0.626
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=176 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=178 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=179 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.
|
-15.98 mmHg
Standard Error 0.723
|
-8.93 mmHg
Standard Error 0.719
|
-16.18 mmHg
Standard Error 0.717
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-31.97 mmHg
Standard Error 1.003
|
-15.73 mmHg
Standard Error 0.988
|
-32.53 mmHg
Standard Error 0.996
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-18.99 mmHg
Standard Error 0.670
|
-7.79 mmHg
Standard Error 0.659
|
-18.82 mmHg
Standard Error 0.665
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-29.43 mmHg
Standard Error 1.087
|
-16.59 mmHg
Standard Error 1.069
|
-29.52 mmHg
Standard Error 1.080
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-17.06 mmHg
Standard Error 0.718
|
-8.89 mmHg
Standard Error 0.707
|
-17.05 mmHg
Standard Error 0.714
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-32.45 mmHg
Standard Error 1.048
|
-15.50 mmHg
Standard Error 1.031
|
-33.02 mmHg
Standard Error 1.039
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-19.20 mmHg
Standard Error 0.710
|
-7.53 mmHg
Standard Error 0.698
|
-19.06 mmHg
Standard Error 0.706
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-30.16 mmHg
Standard Error 1.126
|
-16.69 mmHg
Standard Error 1.108
|
-30.73 mmHg
Standard Error 1.118
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=147 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=152 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=149 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-19.04 mmHg
Standard Error 0.810
|
-9.36 mmHg
Standard Error 0.797
|
-18.78 mmHg
Standard Error 0.804
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=176 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=178 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=179 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
|
84.1 percentage of participants
|
63.5 percentage of participants
|
87.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=176 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=178 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=179 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
|
90.3 percentage of participants
|
78.1 percentage of participants
|
92.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=176 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=178 Participants
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=179 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.
|
80.7 percentage of participants
|
58.4 percentage of participants
|
84.9 percentage of participants
|
Adverse Events
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Chlorthalidone 25 mg QD
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=184 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=182 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=181 participants at risk
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.54%
1/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.55%
1/181 • 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.
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.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.55%
1/181 • 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.
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.
|
|
General disorders
Chest discomfort
|
0.54%
1/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.55%
1/181 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/184 • 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.
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.
|
0.55%
1/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/184 • 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.
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.
|
0.55%
1/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/184 • 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.
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.
|
0.55%
1/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Investigations
Heart rate decreased
|
0.54%
1/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Nervous system disorders
Syncope
|
0.54%
1/184 • 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.
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.
|
0.55%
1/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/184 • 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.
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.
|
0.55%
1/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
|
Vascular disorders
Hypertensive crisis
|
0.54%
1/184 • 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.
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.
|
0.00%
0/182 • 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.
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.
|
0.00%
0/181 • 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.
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.
|
Other adverse events
| Measure |
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
n=184 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
n=182 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
Chlorthalidone 25 mg QD
n=181 participants at risk
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|
|
Investigations
Plasminogen activator inhibitor increased
|
6.5%
12/184 • 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.
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.
|
2.2%
4/182 • 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.
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.
|
1.7%
3/181 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
2/184 • 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.
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.
|
2.2%
4/182 • 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.
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.
|
6.1%
11/181 • 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.
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.
|
|
Nervous system disorders
Dizziness
|
8.7%
16/184 • 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.
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.
|
10.4%
19/182 • 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.
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.
|
3.3%
6/181 • 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.
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.
|
|
Nervous system disorders
Headache
|
4.3%
8/184 • 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.
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.
|
4.9%
9/182 • 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.
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.
|
7.2%
13/181 • 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.
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.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER