Clinical trial NCT01762501: Azilsartan Circadian and Sleep Pressure
Official title: Azilsartan Circadian and Sleep Pressure - the 1st Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Sogo Rinsho Médéfi Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2013-01-07
Enrollment: 957
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Nocturnal Systolic Blood Pressure Level
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**
timeFrame: Baseline and 8 weeks
measure: Change in Nocturnal Diastolic Blood Pressure Level
timeFrame: Baseline and 8 weeks
measure: Change in 24-hour Mean Systolic Blood Pressure Level
timeFrame: Baseline and 8 weeks
measure: Change in 24-hour Mean Diastolic Blood Pressure Level
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Niihama
country: Japan
facility: Jyuzen General Hospital
state: Aichi
city: Tsushima
country: Japan
facility: Junn Clinic
state: Aichi
city: Matsudo
country: Japan
facility: Seikei-kai New Tokyo Hospital
state: Chiba
city: Chikushino
country: Japan
facility: Sanshukai Doi Internal Medicine Clinic
state: Fukuoka
city: Itoshima
country: Japan
facility: Junshinkai Nakamura Cardiovascular Clinic
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Osaki Clinic
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Osamura Medical Clinic
state: Fukuoka
city: Koriyama
country: Japan
facility: Hoshi General Hospital
state: Fukushima
city: Maebashi
country: Japan
facility: Zensyukai Hospital
state: Gunma
city: Asahikawa
country: Japan
facility: Hakushoukai Sano Hospital
state: Hokkaido
city: Asahikawa
country: Japan
facility: Jiseikai Higashiasahikawa Hospital
state: Hokkaido
city: Asahikawa
country: Japan
facility: Koushinkai Shintomi Naika Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Aoki Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Houwakai Sapporo Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Mitani Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Shinkotoni Family Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Shoureikan Shinsapporo Seiryou Hospital
state: Hokkaido
city: Tomakomai
country: Japan
facility: Tomakomai City Hospital
state: Hokkaido
city: Itoshima
country: Japan
facility: Hukuyo naika clinic
state: Hukuoka
city: Kitakyushu
country: Japan
facility: Asunaro medical Clinic
state: Hukuoka
city: Amagasaki
country: Japan
facility: Keiseikai Gohshi Hospital
state: Hyogo
city: Koga
country: Japan
facility: Keijukai Itabashi Clinic
state: Ibaraki
city: Morioka
country: Japan
facility: Kamata medical Clinic
state: Iwate
city: Ichikikushikino
country: Japan
facility: Koyokai Hanamure Hospital
state: Kagoshima
city: Izumi
country: Japan
facility: Izumi General Medical Center
state: Kagoshima
city: Kamakura
country: Japan
facility: Iroden Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Nagasu Clinic
state: Kanagawa
city: Kawasaki
country: Japan
facility: Himawari-kai Kanagawa Himawari Clinic
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kawasaki Saiwai Clinic
state: Kanagawa
city: Kawasaki
country: Japan
facility: Wakoukai Kawasaki Rinko General Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Hakuai Clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kaneshiro Diabetes Clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Yamamoto Clinic
state: Kanagawa
city: Yamato
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Furuie Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Minamisawa Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Shintoukai Yokohama Minoru Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Shuyu-kai Kikuchi Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Tani Clinic
state: Kanagawa
city: Sendai
country: Japan
facility: Higashikatsuyama Nakazawa Naika Allergy Internal Medicine
state: Miyagi
city: Sendai
country: Japan
facility: Shinden Higashi Clinic
state: Miyagi
city: Omura
country: Japan
facility: Meiwakai Izaki Clinic
state: Nagasaki
city: Beppu
country: Japan
facility: Shoninkai Shonin Hospital
state: Oita
city: Tsuyama
country: Japan
facility: Hirano Doujinkai Tsuyama Daiichi Hospital
state: Okayama
city: Wake-gun
country: Japan
facility: Taira Hospital
state: Okayama
city: Takatsuki
country: Japan
facility: Tenjin Tanaka Internal Medicine Clinic
state: Osaka
city: Ageo
country: Japan
facility: Enomoto Clinic
state: Saitama
city: Kazo
country: Japan
facility: Kazo Minami Clinic
state: Saitama
city: Kumagaya
country: Japan
facility: Asukurepiosu Enomoto Clinic
state: Saitama
city: Kumagaya
country: Japan
facility: Shibuya Clinic
state: Saitama
city: Tokorozawa
country: Japan
facility: Genkikai Wakasa Clinic
state: Saitama
city: Hamamatsu
country: Japan
facility: JA Shizuoka Kohseiren Enshu Hospital
state: Shizuoka
city: Shimoda
country: Japan
facility: Shimoda Medical Center
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Utsunomiya
country: Japan
facility: DIC Utsunomiya Central Clinic
state: Tochigi
city: Arakawa-ku
country: Japan
facility: Nippori Clinic
state: Tokyo
city: Chofu
country: Japan
facility: Eireikai Niwa Family Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Keiyu Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Nihonbashikabutocho Nakajima Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Taiseikai Seikoudou Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Hirookai Kanbara Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Ono Medical Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Sawai Medical Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Shinsei-kai Kameido Ekimae Ckinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Shinseikai Kameido Minami-guchi Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Kamada Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Mitaka Health Care Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Murenosato Clinic
state: Tokyo
city: Musashino
country: Japan
facility: Shirayurikai Swing Bldg Nozaki Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Kenkoukan Suzuki Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Keichikai Shimokitazawa Tomo Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Ishinkai Oda Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Ryousyukai Kanauchi Medical Clinic
state: Tokyo
city: Suginami-ku
country: Japan
facility: Shingakai MaO Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Keiseikai Otsuka Kita-guchi Clinic
state: Tokyo
city: Ube
country: Japan
facility: Fujino Clinic
state: Yamaguchi
city: Tsuru
country: Japan
facility: Hirokai Higashikatsura Medical Clinic
state: Yamanashi
city: Fukuoka
country: Japan
facility: Hakataeki-higashi Clinic
city: Fukuoka
country: Japan
facility: Ogata Medical Clinic
city: Fukuoka
country: Japan
facility: Soejima Naika Clinic
city: Hiroshima
country: Japan
facility: Inoue Neurology Clinic
city: Hiroshima
country: Japan
facility: Oda medical Clinic
city: Hukuoka
country: Japan
facility: Aiseikai PS Clinic
city: Nagasaki
country: Japan
facility: Kosei-kai Nijigaoka Hospital
city: Okayama
country: Japan
facility: Seizenkai Okayama Saidaiji Hospital
city: Okayama
country: Japan
facility: Yasuda Clinic
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Osaka
country: Japan
facility: Kouseikai Chimori Medical Clinic
city: Saitama
country: Japan
facility: H&Y Akimoto Naika Clinic
city: Saitama
country: Japan
facility: Shiseidou Tomita Hospital
city: Saitama
country: Japan
facility: Takahashi Clinic
Study officials:
affiliation: Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University
name: Kazuo Kario
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kario K, Hoshide S. Age-related difference in the sleep pressure-lowering effect between an angiotensin II receptor blocker and a calcium channel blocker in Asian hypertensives: the ACS1 Study. Hypertension. 2015 Apr;65(4):729-35. doi: 10.1161/HYPERTENSIONAHA.114.04935. Epub 2015 Feb 2.