Trial Outcomes & Findings for Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension (NCT NCT00362115)

NCT ID: NCT00362115

Last Updated: 2011-04-19

Results Overview

The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 449 participants
• Primary outcome timeframe: Baseline and Week 8.
• Results posted on: 2011-04-19

Participant Flow

Participants enrolled at 76 investigative sites in Argentina, Mexico, Peru and the United States from 16 May 2006 to 07 December 2006.

Participants with mild to moderate uncomplicated essential hypertension were enrolled in one of seven, once-daily (QD) treatment groups.

Participant milestones

Measure	Azilsartan Medoxomil 5 mg QD Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD Matching placebo tablets, orally, once daily for up to 8 weeks.
Overall Study STARTED	65	65	64	63	64	64	64
Overall Study COMPLETED	63	59	57	59	57	57	52
Overall Study NOT COMPLETED	2	6	7	4	7	7	12

Reasons for withdrawal

Measure	Azilsartan Medoxomil 5 mg QD Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD Matching placebo tablets, orally, once daily for up to 8 weeks.
Overall Study Adverse Event	0	1	1	1	2	2	1
Overall Study Protocol Violation	0	0	0	0	0	1	0
Overall Study Lost to Follow-up	0	1	0	0	2	0	1
Overall Study Withdrawal by Subject	1	3	1	0	1	3	4
Overall Study Lack of Efficacy	1	0	5	2	2	0	3
Overall Study Physician Decision	0	0	0	0	0	0	3
Overall Study Other	0	1	0	1	0	1	0

Baseline Characteristics

Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension

Baseline characteristics by cohort

Measure	Azilsartan Medoxomil 5 mg QD n=65 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=63 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=64 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=62 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=64 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=61 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.	Total n=442 Participants Total of all reporting groups
Age Categorical <45 years	12 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants	9 participants n=4 Participants	12 participants n=21 Participants	10 participants n=8 Participants	11 participants n=8 Participants	69 participants n=24 Participants
Age Categorical Between 45 and 64 years	45 participants n=5 Participants	52 participants n=7 Participants	46 participants n=5 Participants	43 participants n=4 Participants	41 participants n=21 Participants	46 participants n=8 Participants	36 participants n=8 Participants	309 participants n=24 Participants
Age Categorical ≥65 years	8 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants	10 participants n=4 Participants	11 participants n=21 Participants	7 participants n=8 Participants	14 participants n=8 Participants	64 participants n=24 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	33 Participants n=4 Participants	28 Participants n=21 Participants	34 Participants n=8 Participants	32 Participants n=8 Participants	218 Participants n=24 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	29 Participants n=4 Participants	36 Participants n=21 Participants	29 Participants n=8 Participants	29 Participants n=8 Participants	224 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8.

Population: Full analysis set with last observation carried forward.

The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=63 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=63 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=63 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=61 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=63 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=58 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure.	-10.8 mmHg Standard Error 1.08	-13.1 mmHg Standard Error 1.08	-11.5 mmHg Standard Error 1.08	-13.6 mmHg Standard Error 1.10	-11.6 mmHg Standard Error 1.08	-11.0 mmHg Standard Error 1.08	-7.9 mmHg Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set with last observation carried forward.

The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=63 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=63 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=63 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=61 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=63 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=58 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Sitting Clinic Systolic Blood Pressure.	-11.0 mmHg Standard Error 1.66	-15.7 mmHg Standard Error 1.66	-14.7 mmHg Standard Error 1.66	-17.1 mmHg Standard Error 1.69	-13.3 mmHg Standard Error 1.66	-13.5 mmHg Standard Error 1.66	-4.9 mmHg Standard Error 1.73

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full analysis set with last observation carried forward.

The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=63 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=63 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=63 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=61 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=62 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=58 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Standing Clinic Systolic Blood Pressure.	-11.4 mmHg Standard Error 1.78	-13.4 mmHg Standard Error 1.78	-16.1 mmHg Standard Error 1.78	-14.6 mmHg Standard Error 1.81	-14.0 mmHg Standard Error 1.79	-11.4 mmHg Standard Error 1.78	-3.3 mmHg Standard Error 1.85

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full analysis set with last observation carried forward.

The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=63 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=63 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=63 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=61 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=62 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=58 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Standing Clinic Diastolic Blood Pressure.	-9.2 mmHg Standard Error 1.17	-11.0 mmHg Standard Error 1.18	-10.2 mmHg Standard Error 1.17	-11.3 mmHg Standard Error 1.19	-11.2 mmHg Standard Error 1.18	-10.8 mmHg Standard Error 1.17	-6.9 mmHg Standard Error 1.23

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.5 mmHg Standard Error 1.34	-12.1 mmHg Standard Error 1.49	-11.1 mmHg Standard Error 1.46	-15.8 mmHg Standard Error 1.57	-12.4 mmHg Standard Error 1.49	-9.3 mmHg Standard Error 1.42	1.0 mmHg Standard Error 1.53

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-4.2 mmHg Standard Error 0.90	-7.3 mmHg Standard Error 1.01	-7.5 mmHg Standard Error 0.99	-9.6 mmHg Standard Error 1.06	-8.2 mmHg Standard Error 1.01	-6.2 mmHg Standard Error 0.96	1.2 mmHg Standard Error 1.03

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.2 mmHg Standard Error 1.54	-13.0 mmHg Standard Error 1.72	-11.8 mmHg Standard Error 1.68	-17.2 mmHg Standard Error 1.80	-13.0 mmHg Standard Error 1.72	-7.4 mmHg Standard Error 1.63	0.6 mmHg Standard Error 1.76

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-3.6 mmHg Standard Error 1.05	-7.3 mmHg Standard Error 1.18	-8.0 mmHg Standard Error 1.15	-10.0 mmHg Standard Error 1.23	-8.7 mmHg Standard Error 1.18	-5.1 mmHg Standard Error 1.12	0.6 mmHg Standard Error 1.21

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=54 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=40 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=41 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-8.0 mmHg Standard Error 1.93	-11.4 mmHg Standard Error 2.14	-12.2 mmHg Standard Error 2.12	-17.4 mmHg Standard Error 2.24	-13.7 mmHg Standard Error 2.12	-7.8 mmHg Standard Error 2.03	0.1 mmHg Standard Error 2.22

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=54 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=40 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=41 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-3.8 mmHg Standard Error 1.37	-5.7 mmHg Standard Error 1.52	-7.4 mmHg Standard Error 1.50	-9.1 mmHg Standard Error 1.59	-8.8 mmHg Standard Error 1.50	-4.7 mmHg Standard Error 1.44	0.5 mmHg Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full Analysis Set.

The change in trough mean systolic blood pressure measured at week 8 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 5 mg QD n=53 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=43 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=38 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=44 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=48 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=39 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-10.9 mmHg Standard Error 1.78	-14.9 mmHg Standard Error 1.98	-12.0 mmHg Standard Error 1.93	-18.8 mmHg Standard Error 2.10	-13.9 mmHg Standard Error 1.95	-13.8 mmHg Standard Error 1.87	-1.5 mmHg Standard Error 2.08

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in trough mean diastolic blood pressure measured at week 8 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 5 mg QD n=53 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=43 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=38 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=44 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=48 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=39 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.6 mmHg Standard Error 1.27	-11.3 mmHg Standard Error 1.41	-8.9 mmHg Standard Error 1.38	-14.0 mmHg Standard Error 1.50	-9.0 mmHg Standard Error 1.39	-9.6 mmHg Standard Error 1.33	-0.3 mmHg Standard Error 1.48

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.8 mmHg Standard Error 1.43	-13.0 mmHg Standard Error 1.59	-11.6 mmHg Standard Error 1.56	-17.3 mmHg Standard Error 1.67	-13.1 mmHg Standard Error 1.59	-8.6 mmHg Standard Error 1.51	0.7 mmHg Standard Error 1.63

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=56 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=45 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=47 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=41 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=50 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=43 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-4.2 mmHg Standard Error 0.96	-7.7 mmHg Standard Error 1.07	-8.0 mmHg Standard Error 1.05	-10.6 mmHg Standard Error 1.12	-8.7 mmHg Standard Error 1.07	-6.0 mmHg Standard Error 1.01	0.7 mmHg Standard Error 1.09

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=54 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=46 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=39 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=44 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=40 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.3 mmHg Standard Error 1.56	-11.1 mmHg Standard Error 1.73	-10.4 mmHg Standard Error 1.69	-13.1 mmHg Standard Error 1.83	-11.4 mmHg Standard Error 1.72	-10.6 mmHg Standard Error 1.63	1.3 mmHg Standard Error 1.81

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=54 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=46 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=39 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=44 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=40 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-4.8 mmHg Standard Error 1.09	-7.4 mmHg Standard Error 1.21	-6.8 mmHg Standard Error 1.18	-8.5 mmHg Standard Error 1.29	-7.8 mmHg Standard Error 1.21	-6.1 mmHg Standard Error 1.15	1.9 mmHg Standard Error 1.27

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=52 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=40 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=41 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-9.4 mmHg Standard Error 1.51	-12.0 mmHg Standard Error 1.64	-11.5 mmHg Standard Error 1.62	-14.6 mmHg Standard Error 1.72	-13.5 mmHg Standard Error 1.62	-8.9 mmHg Standard Error 1.56	-1.4 mmHg Standard Error 1.70

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=52 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=44 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=45 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=40 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=45 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=49 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=41 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-5.6 mmHg Standard Error 1.07	-7.9 mmHg Standard Error 1.17	-8.6 mmHg Standard Error 1.15	-9.5 mmHg Standard Error 1.22	-7.9 mmHg Standard Error 1.15	-6.5 mmHg Standard Error 1.11	-0.4 mmHg Standard Error 1.21

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full Analysis Set.

The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=49 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=43 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=41 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=33 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=42 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=42 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=40 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-10.1 mmHg Standard Error 1.96	-11.2 mmHg Standard Error 2.10	-9.8 mmHg Standard Error 2.15	-13.5 mmHg Standard Error 2.39	-11.8 mmHg Standard Error 2.12	-7.4 mmHg Standard Error 2.12	-0.9 mmHg Standard Error 2.17

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Full Analysis Set.

The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.

Outcome measures

Measure	Azilsartan Medoxomil 5 mg QD n=45 Participants Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=38 Participants Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=39 Participants Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=31 Participants Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=34 Participants Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=33 Participants Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=36 Participants Matching placebo tablets, orally, once daily for up to 8 weeks.
Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-0.4 mmHg Standard Error 1.16	0.3 mmHg Standard Error 1.26	0.9 mmHg Standard Error 1.24	0.4 mmHg Standard Error 1.40	-0.6 mmHg Standard Error 1.34	1.9 mmHg Standard Error 1.35	2.4 mmHg Standard Error 1.31

Adverse Events

Azilsartan Medoxomil 5 mg QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Azilsartan Medoxomil 10 mg QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Azilsartan Medoxomil 20 mg QD

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Azilsartan Medoxomil 40 mg QD

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Azilsartan Medoxomil 80 mg QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Olmesartan 20 mg QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Azilsartan Medoxomil 5 mg QD n=65 participants at risk Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=64 participants at risk Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=64 participants at risk Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=62 participants at risk Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=64 participants at risk Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 participants at risk Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=63 participants at risk Matching placebo tablets, orally, once daily for up to 8 weeks.
Cardiac disorders Cardiac Arrest	0.00% 0/65 • 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% 0/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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.	1.6% 1/63 • 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% 0/63 • 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 Hypertensive Heart Disease	0.00% 0/65 • 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% 0/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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.	1.6% 1/63 • 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% 0/63 • 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	0.00% 0/65 • 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% 0/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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% 0/63 • 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.	1.6% 1/63 • 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% 0/65 • 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% 0/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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% 0/63 • 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.	1.6% 1/63 • 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 Oesophageal Spasm	0.00% 0/65 • 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% 0/64 • 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% 0/64 • 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.	1.6% 1/62 • 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% 0/64 • 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% 0/63 • 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% 0/63 • 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 Wound Infection	1.5% 1/65 • 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% 0/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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% 0/63 • 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% 0/63 • 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	0.00% 0/65 • 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.	1.6% 1/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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% 0/63 • 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% 0/63 • 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 Hydrocephalus	0.00% 0/65 • 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.	1.6% 1/64 • 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% 0/64 • 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% 0/62 • 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% 0/64 • 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% 0/63 • 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% 0/63 • 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 5 mg QD n=65 participants at risk Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 10 mg QD n=64 participants at risk Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 20 mg QD n=64 participants at risk Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 40 mg QD n=62 participants at risk Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Azilsartan Medoxomil 80 mg QD n=64 participants at risk Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Olmesartan 20 mg QD n=63 participants at risk Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.	Placebo QD n=63 participants at risk Matching placebo tablets, orally, once daily for up to 8 weeks.
Nervous system disorders Headache	3.1% 2/65 • 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.	1.6% 1/64 • 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.	10.9% 7/64 • 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.	4.8% 3/62 • 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.	4.7% 3/64 • 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.	7.9% 5/63 • 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.	4.8% 3/63 • 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 Nasopharyngitis	0.00% 0/65 • 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.	4.7% 3/64 • 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.	4.7% 3/64 • 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.	1.6% 1/62 • 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.	4.7% 3/64 • 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.	1.6% 1/63 • 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.	6.3% 4/63 • 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	1.5% 1/65 • 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.	4.7% 3/64 • 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.	6.2% 4/64 • 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% 2/62 • 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.	1.6% 1/64 • 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.	1.6% 1/63 • 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% 2/63 • 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 Upper respiratory tract infection	6.2% 4/65 • 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% 0/64 • 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% 0/64 • 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% 2/62 • 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% 0/64 • 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% 0/63 • 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% 0/63 • 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: clinicaltrialregistry@tpna.com

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