Trial Outcomes & Findings for Azilsartan Circadian and Sleep Pressure (NCT NCT01762501)

NCT ID: NCT01762501

Last Updated: 2015-12-28

Results Overview

Change at the end of a treatment period (Week 8) from the beginning point of an observation period \*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 957 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2015-12-28

Participant Flow

Enrollment was performed at hospital and clinic

957 patients was enrolled in this study. In run-in period, 239 patients were withdrawn.

Participant milestones

Measure	Azilsartan Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Overall Study STARTED	359	359
Overall Study COMPLETED	332	336
Overall Study NOT COMPLETED	27	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Azilsartan Circadian and Sleep Pressure

Baseline characteristics by cohort

Measure	Azilsartan n=359 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day	Total n=718 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 12 • n=5 Participants	61 years STANDARD_DEVIATION 12 • n=7 Participants	61 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	157 Participants n=5 Participants	157 Participants n=7 Participants	314 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	202 Participants n=7 Participants	404 Participants n=5 Participants
Region of Enrollment Japan	359 participants n=5 Participants	359 participants n=7 Participants	718 participants n=5 Participants
Clinic SBP	149.6 mmHg STANDARD_DEVIATION 10.2 • n=5 Participants	150.5 mmHg STANDARD_DEVIATION 10.2 • n=7 Participants	150.1 mmHg STANDARD_DEVIATION 10.2 • n=5 Participants
Clinic DBP	90.3 mmHg STANDARD_DEVIATION 9.4 • n=5 Participants	89.8 mmHg STANDARD_DEVIATION 9.6 • n=7 Participants	90.1 mmHg STANDARD_DEVIATION 9.5 • n=5 Participants
24-hour SBP	150.6 mmHg STANDARD_DEVIATION 13.0 • n=5 Participants	152.4 mmHg STANDARD_DEVIATION 13.7 • n=7 Participants	151.5 mmHg STANDARD_DEVIATION 13.4 • n=5 Participants
24-hour DBP	89.3 mmHg STANDARD_DEVIATION 8.6 • n=5 Participants	90.4 mmHg STANDARD_DEVIATION 9.3 • n=7 Participants	89.8 mmHg STANDARD_DEVIATION 9.0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Change at the end of a treatment period (Week 8) from the beginning point of an observation period

*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)

Outcome measures

Measure	Azilsartan n=359 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Change in Nocturnal Systolic Blood Pressure Level	-12.6 mmHg Standard Deviation 15.4	-17.5 mmHg Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)

** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP

Outcome measures

Measure	Azilsartan n=321 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=331 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** riser	-7.3 mmHg Interval -10.0 to -4.5	-10.1 mmHg Interval -13.5 to -6.6
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** non-dipper	-0.7 mmHg Interval -1.9 to 0.6	-2.1 mmHg Interval -3.1 to -1.1
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** dipper	4.5 mmHg Interval 3.6 to 5.4	3.1 mmHg Interval 2.3 to 3.8
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** extreme dipper	-1.9 mmHg Interval -3.9 to 0.1	-3.1 mmHg Interval -4.9 to -1.2

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

Outcome measures

Measure	Azilsartan n=359 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Change in Nocturnal Diastolic Blood Pressure Level	-7.1 mmHg Standard Deviation 8.5	-8.9 mmHg Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

Outcome measures

Measure	Azilsartan n=359 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Change in 24-hour Mean Systolic Blood Pressure Level	-14.0 mmHg Standard Deviation 13.3	-17.5 mmHg Standard Deviation 11.5

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

Outcome measures

Measure	Azilsartan n=359 Participants Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 Participants Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Change in 24-hour Mean Diastolic Blood Pressure Level	-7.9 mmHg Standard Deviation 7.5	-8.9 mmHg Standard Deviation 6.3

Adverse Events

Azilsartan

Serious events: 0 serious events

Other events: 91 other events

Deaths: 0 deaths

Amlodipine

Serious events: 5 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Measure	Azilsartan n=359 participants at risk Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 participants at risk Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Gastrointestinal disorders Diverticulitis	0.00% 0/359 • 8weeks	0.28% 1/359 • 8weeks
Vascular disorders Stroke	0.00% 0/359 • 8weeks	0.28% 1/359 • 8weeks
Skin and subcutaneous tissue disorders Nettle rash	0.00% 0/359 • 8weeks	0.28% 1/359 • 8weeks
Gastrointestinal disorders Cancer	0.00% 0/359 • 8weeks	0.56% 2/359 • 8weeks

Other adverse events

Measure	Azilsartan n=359 participants at risk Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	Amlodipine n=359 participants at risk Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day
Infections and infestations Infectious disease	8.4% 30/359 • 8weeks	9.5% 34/359 • 8weeks
Musculoskeletal and connective tissue disorders Other	17.3% 62/359 • 8weeks	13.6% 49/359 • 8weeks

Additional Information

Naoyuki Takano

Sogo Rinsho Medefi Co., Ltd

Phone: +81-3-6901-6079

Email: takano.naoyuki@sogo-medefi.jp

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PIs is that PIs must get approval about publish by study director(Kazuo Kario).
• Publication restrictions are in place

Restriction type: OTHER