Trial Outcomes & Findings for Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension (NCT NCT00591253)

NCT ID: NCT00591253

Last Updated: 2011-04-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 413 participants
• Primary outcome timeframe: Baseline and Week 6.
• Results posted on: 2011-04-19

Participant Flow

Participants enrolled at 74 investigative sites in Puerto Rico and the United States from 30 October 2007 to 30 April 2009.

Black participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.

Participant milestones

Measure	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.	Placebo QD Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Study STARTED	140	137	138
Overall Study COMPLETED	126	116	123
Overall Study NOT COMPLETED	14	21	15

Reasons for withdrawal

Measure	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.	Placebo QD Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Study Adverse Event	3	3	1
Overall Study Protocol Violation	2	2	2
Overall Study Lost to Follow-up	2	4	0
Overall Study Withdrawal by Subject	1	7	6
Overall Study Lack of Efficacy	1	0	3
Overall Study Other	5	5	3

Baseline Characteristics

Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension

Baseline characteristics by cohort

Measure	Azilsartan Medoxomil 40 mg QD n=138 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=137 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=138 Participants Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.	Total n=413 Participants Total of all reporting groups
Age Categorical <45 years	29 participants n=5 Participants	37 participants n=7 Participants	36 participants n=5 Participants	102 participants n=4 Participants
Age Categorical Between 45 and 64 years	94 participants n=5 Participants	86 participants n=7 Participants	85 participants n=5 Participants	265 participants n=4 Participants
Age Categorical ≥65 years	15 participants n=5 Participants	14 participants n=7 Participants	17 participants n=5 Participants	46 participants n=4 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	80 Participants n=7 Participants	78 Participants n=5 Participants	236 Participants n=4 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	57 Participants n=7 Participants	60 Participants n=5 Participants	177 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-7.70 mmHg Standard Error 1.063	-10.48 mmHg Standard Error 1.026	-2.70 mmHg Standard Error 1.065

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 40 mg QD n=134 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=130 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=133 Participants Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure	-9.51 mmHg Standard Error 1.330	-9.58 mmHg Standard Error 1.351	-3.04 mmHg Standard Error 1.333

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-4.93 mmHg Standard Error 0.732	-7.27 mmHg Standard Error 0.706	-1.49 mmHg Standard Error 0.731

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 40 mg QD n=134 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=130 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=133 Participants Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure	-5.48 mmHg Standard Error 0.755	-5.32 mmHg Standard Error 0.766	-2.36 mmHg Standard Error 0.757

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-7.53 mmHg Standard Error 1.094	-10.40 mmHg Standard Error 1.056	-2.43 mmHg Standard Error 1.096

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-5.08 mmHg Standard Error 0.764	-7.24 mmHg Standard Error 0.738	-1.34 mmHg Standard Error 0.764

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-7.97 mmHg Standard Error 1.303	-10.34 mmHg Standard Error 1.259	-3.06 mmHg Standard Error 1.307

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-4.48 mmHg Standard Error 0.950	-7.23 mmHg Standard Error 0.916	-1.44 mmHg Standard Error 0.950

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-7.70 mmHg Standard Error 1.155	-10.11 mmHg Standard Error 1.114	-2.40 mmHg Standard Error 1.156

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.	-5.15 mmHg Standard Error 0.815	-6.99 mmHg Standard Error 0.788	-1.34 mmHg Standard Error 0.816

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-7.14 mmHg Standard Error 1.382	-10.99 mmHg Standard Error 1.334	-2.28 mmHg Standard Error 1.385

SECONDARY outcome

Timeframe: Baseline and Week 6.

Population: Full Analysis Set.

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

Outcome measures

Measure	Azilsartan Medoxomil 40 mg QD n=94 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=101 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=94 Participants Azilsartan medoxomil 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.	-4.77 mmHg Standard Error 1.126	-8.28 mmHg Standard Error 1.085	-0.73 mmHg Standard Error 1.125

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 40 mg QD n=134 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=130 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=133 Participants Azilsartan medoxomil 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	41.8 percentage of participants	37.7 percentage of participants	24.8 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 40 mg QD n=134 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=130 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=133 Participants Azilsartan medoxomil 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	53.0 percentage of participants	55.4 percentage of participants	39.8 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 40 mg QD n=134 Participants Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=130 Participants Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=133 Participants Azilsartan medoxomil 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	32.1 percentage of participants	34.6 percentage of participants	16.5 percentage of participants

Adverse Events

Azilsartan Medoxomil 40 mg QD

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Azilsartan Medoxomil 80 mg QD

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Azilsartan Medoxomil 40 mg QD n=137 participants at risk Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=137 participants at risk Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=138 participants at risk Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/137 • 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.	0.73% 1/137 • 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% 0/138 • 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 Diabetic ketoacidosis	0.73% 1/137 • 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% 0/137 • 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% 0/138 • 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 Cerebral haemorrhage	0.73% 1/137 • 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% 0/137 • 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% 0/138 • 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 Asthma	0.73% 1/137 • 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% 0/137 • 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% 0/138 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Azilsartan Medoxomil 40 mg QD n=137 participants at risk Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.	Azilsartan Medoxomil 80 mg QD n=137 participants at risk Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.	Placebo QD n=138 participants at risk Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Nervous system disorders Headache	4.4% 6/137 • 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.	6.6% 9/137 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 3/138 • 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