Azilsartan Circadian and Sleep Pressure

Azilsartan Circadian and Sleep Pressure - the 1st Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762501

Enrollment

957

Registered

2013-01-07

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2015-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension

Brief summary

To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once per day for 8 weeks in patients with grade I or grade II essential hypertension.

Detailed description

Treatment \<Run-in period\> Use of any antihypertensives, including azilsartan and amlodipine, is prohibited during the run-in period. \<Treatment period\> Subjects who are considered eligible for participation in the study based on the results of eligibility assessment during the run-in period will be randomized to the azilsartan 20 mg or amlodipine 5 mg group at a ratio of 1:1 according to the following stratification factors; the type of awake-sleep blood pressure variation determined based on the data from ABPM at the start of run-in, complication status (chronic kidney diseases \[CKD\], type 2 diabetes), age, and sex. Subjects will start treatment with either antihypertensive after examination for the start of treatment (Week 0) and visit the study site every 2 weeks, 5 visits in total, until the end of treatment (Week 8). Subjects will orally take azilsartan 20 mg or amlodipine 5 mg, according to their group allocation, once daily before or after breakfast in the morning.

Interventions

DRUGAzilsartan

Azilsartan 20mg/day

DRUGAmlodipine

Amlodipine 5mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Grade I or II essential hypertension * The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0) * 20 years old or older at the time of the informed consent * Able to give written informed consent before participating in the research * Therapeutic category during the observation period: Ambulatory

Exclusion criteria

* Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), malignant hypertension * More than 2 kinds of antihypertensive agents for treatment on the hypertension * History of taking following medicines within 2 weeks before start of the observation period. When subject with taking any of the following medicine at the time of informed consent is included, stop to take the medicine for determined period after the informed consent. I. Antihypertensive agents II. Antianginal agents III. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) IV. Digitalis products * Less than 130 mmHg of mean 24-hour systolic blood pressure and less than 80 mmHg of mean 24-hour diastolic blood pressure at the start of the observation period. * History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period. I. Cardiac disease: Myocardial infarction, coronary artery revascularization II. Cerebrovascular-disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack III. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema * History or complication with the following circulatory-related diseases; Valvular stenosis, atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythmia, or arteriosclerosis obliterans with symptoms of intermittent claudication et al * Day / night reversal * History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs * Participant in any other clinical research * Pregnant, possible to being pregnant, or lactating woman * Mal-control of blood pressure during informed consent to taking antihypertensive agent * Any those the investigator or other researchers consider as unsuitable

Design outcomes

Primary

Measure	Time frame	Description
Change in Nocturnal Systolic Blood Pressure Level	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)

Secondary

Measure	Time frame	Description
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**	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
Change in Nocturnal Diastolic Blood Pressure Level	Baseline and 8 weeks	Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)
Change in 24-hour Mean Systolic Blood Pressure Level	Baseline and 8 weeks	Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)
Change in 24-hour Mean Diastolic Blood Pressure Level	Baseline and 8 weeks	Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

Countries

Japan

Participant flow

Recruitment details

Enrollment was performed at hospital and clinic

Pre-assignment details

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

Participants by arm

Arm	Count
Azilsartan Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day	359
Amlodipine Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day	359
Total	718

Baseline characteristics

Characteristic	Total	Amlodipine	Azilsartan
24-hour DBP	89.8 mmHg STANDARD_DEVIATION 9	90.4 mmHg STANDARD_DEVIATION 9.3	89.3 mmHg STANDARD_DEVIATION 8.6
24-hour SBP	151.5 mmHg STANDARD_DEVIATION 13.4	152.4 mmHg STANDARD_DEVIATION 13.7	150.6 mmHg STANDARD_DEVIATION 13
Age, Continuous	61 years STANDARD_DEVIATION 12	61 years STANDARD_DEVIATION 12	61 years STANDARD_DEVIATION 12
Clinic DBP	90.1 mmHg STANDARD_DEVIATION 9.5	89.8 mmHg STANDARD_DEVIATION 9.6	90.3 mmHg STANDARD_DEVIATION 9.4
Clinic SBP	150.1 mmHg STANDARD_DEVIATION 10.2	150.5 mmHg STANDARD_DEVIATION 10.2	149.6 mmHg STANDARD_DEVIATION 10.2
Region of Enrollment Japan	718 participants	359 participants	359 participants
Sex: Female, Male Female	314 Participants	157 Participants	157 Participants
Sex: Female, Male Male	404 Participants	202 Participants	202 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	91 / 359	77 / 359
serious Total, serious adverse events	0 / 359	5 / 359

Outcome results

Primary

Change in Nocturnal Systolic Blood Pressure Level

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)