Trial Outcomes & Findings for Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension (NCT NCT00696241)
NCT ID: NCT00696241
Last Updated: 2011-07-29
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
1275 participants
Primary outcome timeframe
Baseline and Week 6.
Results posted on
2011-07-29
Participant Flow
Participants enrolled at 147 investigative sites in Argentina, Mexico, Peru and the United States from 25 June 2007 to 08 October 2008.
Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Azilsartan Medoxomil 20 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
283
|
283
|
285
|
282
|
142
|
|
Overall Study
COMPLETED
|
259
|
261
|
261
|
268
|
130
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
24
|
14
|
12
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil 20 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
3
|
6
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
6
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
4
|
5
|
3
|
|
Overall Study
Other
|
6
|
1
|
5
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil 20 mg QD
n=283 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=283 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=285 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=282 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=142 Participants
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
Total
n=1275 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Categorical
<45 years
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
37 participants
n=5 Participants
|
32 participants
n=4 Participants
|
11 participants
n=21 Participants
|
141 participants
n=8 Participants
|
|
Age Categorical
Between 45 and 64 years
|
173 participants
n=5 Participants
|
187 participants
n=7 Participants
|
161 participants
n=5 Participants
|
153 participants
n=4 Participants
|
84 participants
n=21 Participants
|
758 participants
n=8 Participants
|
|
Age Categorical
≥65 years
|
78 participants
n=5 Participants
|
67 participants
n=7 Participants
|
87 participants
n=5 Participants
|
97 participants
n=4 Participants
|
47 participants
n=21 Participants
|
376 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
635 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
640 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-12.15 mmHg
Standard Error 0.709
|
-13.48 mmHg
Standard Error 0.704
|
-14.62 mmHg
Standard Error 0.706
|
-12.56 mmHg
Standard Error 0.696
|
-1.40 mmHg
Standard Error 1.004
|
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 20 mg QD
n=274 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=279 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=280 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=140 Participants
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
|
-14.28 mmHg
Standard Error 0.956
|
-14.47 mmHg
Standard Error 0.952
|
-17.58 mmHg
Standard Error 0.947
|
-14.87 mmHg
Standard Error 0.945
|
-2.06 mmHg
Standard Error 1.337
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-7.47 mmHg
Standard Error 0.458
|
-8.38 mmHg
Standard Error 0.455
|
-8.61 mmHg
Standard Error 0.456
|
-7.74 mmHg
Standard Error 0.449
|
-0.69 mmHg
Standard Error 0.649
|
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.
Outcome measures
| Measure |
Azilsartan Medoxomil 20 mg QD
n=274 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=279 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=280 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=140 Participants
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
|
-6.82 mmHg
Standard Error 0.535
|
-6.86 mmHg
Standard Error 0.533
|
-8.42 mmHg
Standard Error 0.530
|
-6.91 mmHg
Standard Error 0.529
|
0.21 mmHg
Standard Error 0.749
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-12.57 mmHg
Standard Error 0.751
|
-13.75 mmHg
Standard Error 0.746
|
-14.96 mmHg
Standard Error 0.747
|
-12.73 mmHg
Standard Error 0.737
|
-1.54 mmHg
Standard Error 1.064
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-7.71 mmHg
Standard Error 0.490
|
-8.43 mmHg
Standard Error 0.487
|
-8.87 mmHg
Standard Error 0.488
|
-7.82 mmHg
Standard Error 0.481
|
-0.59 mmHg
Standard Error 0.695
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-11.10 mmHg
Standard Error 0.781
|
-12.39 mmHg
Standard Error 0.775
|
-13.35 mmHg
Standard Error 0.777
|
-12.13 mmHg
Standard Error 0.766
|
-0.97 mmHg
Standard Error 1.105
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-6.98 mmHg
Standard Error 0.533
|
-7.90 mmHg
Standard Error 0.530
|
-7.79 mmHg
Standard Error 0.531
|
-7.62 mmHg
Standard Error 0.523
|
-0.96 mmHg
Standard Error 0.755
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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
|
-12.72 mmHg
Standard Error 0.795
|
-14.05 mmHg
Standard Error 0.790
|
-15.18 mmHg
Standard Error 0.791
|
-13.07 mmHg
Standard Error 0.780
|
-1.36 mmHg
Standard Error 1.126
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=243 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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
|
-7.72 mmHg
Standard Error 0.519
|
-8.63 mmHg
Standard Error 0.516
|
-8.88 mmHg
Standard Error 0.517
|
-7.86 mmHg
Standard Error 0.510
|
-0.47 mmHg
Standard Error 0.736
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=242 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-12.15 mmHg
Standard Error 0.864
|
-12.39 mmHg
Standard Error 0.858
|
-13.42 mmHg
Standard Error 0.862
|
-11.10 mmHg
Standard Error 0.848
|
-1.21 mmHg
Standard Error 1.224
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Full analysis set with last observation carried forward.
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 20 mg QD
n=241 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=244 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=242 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=250 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=120 Participants
Placebo-matching 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.
|
-7.96 mmHg
Standard Error 0.614
|
-7.93 mmHg
Standard Error 0.610
|
-8.68 mmHg
Standard Error 0.612
|
-7.56 mmHg
Standard Error 0.603
|
-1.12 mmHg
Standard Error 0.870
|
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 20 mg QD
n=274 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=279 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=281 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=140 Participants
Placebo-matching 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
|
47.8 percentage of participants
|
50.4 percentage of participants
|
56.6 percentage of participants
|
53.2 percentage of participants
|
17.1 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 20 mg QD
n=274 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=279 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=281 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=140 Participants
Placebo-matching 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
|
67.5 percentage of participants
|
71.0 percentage of participants
|
73.5 percentage of participants
|
73.9 percentage of participants
|
47.9 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 20 mg QD
n=274 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=279 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=281 Participants
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=140 Participants
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
|
42.7 percentage of participants
|
45.3 percentage of participants
|
52.0 percentage of participants
|
47.5 percentage of participants
|
14.3 percentage of participants
|
Adverse Events
Azilsartan Medoxomil 20 mg QD
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Azilsartan Medoxomil 40 mg QD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Azilsartan Medoxomil 80 mg QD
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Olmesartan 40 mg QD
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo QD
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan Medoxomil 20 mg QD
n=283 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=281 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=284 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=282 participants at risk
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=142 participants at risk
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Ischaemic stroke
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
Transient ischaemic attack
|
0.00%
0/283 • 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%
0/281 • 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.
|
0.35%
1/284 • 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%
0/282 • 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%
0/142 • 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
Atrial fibrillation
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
Coronary artery disease
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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.
|
0.70%
1/142 • 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
Myocardial infarction
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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.
|
0.35%
1/282 • 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%
0/142 • 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 pain
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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.
|
0.70%
1/142 • 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.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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.
|
0.35%
1/282 • 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%
0/142 • 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
Cellulitis
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
Lower respiratory tract infection
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
Epilepsy
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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
Ischaemia
|
0.00%
0/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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.
|
0.70%
1/142 • 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
Shock
|
0.35%
1/283 • 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%
0/281 • 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%
0/284 • 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%
0/282 • 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%
0/142 • 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 20 mg QD
n=283 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 40 mg QD
n=281 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=284 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
|
Olmesartan 40 mg QD
n=282 participants at risk
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
|
Placebo QD
n=142 participants at risk
Placebo-matching tablets, orally, once daily for up to 6 weeks.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.6%
13/283 • 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.
|
3.2%
9/281 • 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.
|
5.6%
16/284 • 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.
|
3.2%
9/282 • 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.
|
7.0%
10/142 • 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
Dyslipidemia
|
3.5%
10/283 • 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.
|
3.9%
11/281 • 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.
|
5.6%
16/284 • 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.
|
3.5%
10/282 • 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.
|
2.1%
3/142 • 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