Azilsartan Circadian and Sleep Pressure

NCT ID: NCT01762501

Last Updated: 2015-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 957 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

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.

Conditions

Hypertension

Keywords

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azilsartan

Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks

Group Type: EXPERIMENTAL

Azilsartan

Intervention Type: DRUG

Azilsartan 20mg/day

Amlodipine

Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Amlodipine 5mg/day

Interventions

Azilsartan

Azilsartan 20mg/day

Intervention Type: DRUG

Amlodipine

Amlodipine 5mg/day

Intervention Type: DRUG

Other Intervention Names

AZILVA Tablets; Amlodin Tablets etc.

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Sogo Rinsho Médéfi Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuo Kario

Role: PRINCIPAL_INVESTIGATOR

Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University

Locations

Jyuzen General Hospital

Niihama, Aichi-ken, Japan

Junn Clinic

Tsushima, Aichi-ken, Japan

Seikei-kai New Tokyo Hospital

Matsudo, Chiba, Japan

Sanshukai Doi Internal Medicine Clinic

Chikushino-shi, Fukuoka, Japan

Hakataeki-higashi Clinic

Fukuoka, Fukuoka, Japan

Ogata Medical Clinic

Fukuoka, Fukuoka, Japan

Soejima Naika Clinic

Fukuoka, Fukuoka, Japan

Junshinkai Nakamura Cardiovascular Clinic

Itoshima, Fukuoka, Japan

Osaki Clinic

Kitakyushu, Fukuoka, Japan

Osamura Medical Clinic

Kitakyushu, Fukuoka, Japan

Hoshi General Hospital

Kōriyama, Fukushima, Japan

Zensyukai Hospital

Maebashi, Gunma, Japan

Inoue Neurology Clinic

Hiroshima, Hiroshima, Japan

Oda medical Clinic

Hiroshima, Hiroshima, Japan

Hakushoukai Sano Hospital

Asahikawa, Hokkaido, Japan

Jiseikai Higashiasahikawa Hospital

Asahikawa, Hokkaido, Japan

Koushinkai Shintomi Naika Clinic

Asahikawa, Hokkaido, Japan

Aoki Clinic

Sapporo, Hokkaido, Japan

Houwakai Sapporo Hospital

Sapporo, Hokkaido, Japan

Mitani Clinic

Sapporo, Hokkaido, Japan

Shinkotoni Family Clinic

Sapporo, Hokkaido, Japan

Shoureikan Shinsapporo Seiryou Hospital

Sapporo, Hokkaido, Japan

Tomakomai City Hospital

Tomakomai, Hokkaido, Japan

Aiseikai PS Clinic

Fukuoka, Hukuoka, Japan

Hukuyo naika clinic

Itoshima, Hukuoka, Japan

Asunaro medical Clinic

Kitakyushu, Hukuoka, Japan

Keiseikai Gohshi Hospital

Amagasaki, Hyōgo, Japan

Keijukai Itabashi Clinic

Koga, Ibaraki, Japan

Kamata medical Clinic

Morioka, Iwate, Japan

Koyokai Hanamure Hospital

Ichikikushikino, Kagoshima-ken, Japan

Izumi General Medical Center

Izumi, Kagoshima-ken, Japan

Iroden Clinic

Kamakura, Kanagawa, Japan

Nagasu Clinic

Kamakura, Kanagawa, Japan

Himawari-kai Kanagawa Himawari Clinic

Kawasaki, Kanagawa, Japan

Kawasaki Saiwai Clinic

Kawasaki, Kanagawa, Japan

Wakoukai Kawasaki Rinko General Hospital

Kawasaki, Kanagawa, Japan

Hakuai Clinic

Sagamihara, Kanagawa, Japan

Kaneshiro Diabetes Clinic

Sagamihara, Kanagawa, Japan

Yamamoto Clinic

Sagamihara, Kanagawa, Japan

Tsuruma Kaneshiro Diabetes Clinic

Yamato, Kanagawa, Japan

Furuie Clinic

Yokohama, Kanagawa, Japan

Minamisawa Clinic

Yokohama, Kanagawa, Japan

Shintoukai Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Shuyu-kai Kikuchi Clinic

Yokohama, Kanagawa, Japan

Tani Clinic

Yokohama, Kanagawa, Japan

Higashikatsuyama Nakazawa Naika Allergy Internal Medicine

Sendai, Miyagi, Japan

Shinden Higashi Clinic

Sendai, Miyagi, Japan

Kosei-kai Nijigaoka Hospital

Nagasaki, Nagasaki, Japan

Meiwakai Izaki Clinic

Ōmura, Nagasaki, Japan

Shoninkai Shonin Hospital

Beppu, Oita Prefecture, Japan

Seizenkai Okayama Saidaiji Hospital

Okayama, Okayama-ken, Japan

Yasuda Clinic

Okayama, Okayama-ken, Japan

Hirano Doujinkai Tsuyama Daiichi Hospital

Tsuyama, Okayama-ken, Japan

Taira Hospital

Wake-gun, Okayama-ken, Japan

AMC Nishiumeda Clinic

Osaka, Osaka, Japan

Kouseikai Chimori Medical Clinic

Osaka, Osaka, Japan

Tenjin Tanaka Internal Medicine Clinic

Takatsuki, Osaka, Japan

Enomoto Clinic

Ageo, Saitama, Japan

Kazo Minami Clinic

Kazo, Saitama, Japan

Asukurepiosu Enomoto Clinic

Kumagaya, Saitama, Japan

Shibuya Clinic

Kumagaya, Saitama, Japan

H&Y Akimoto Naika Clinic

Saitama, Saitama, Japan

Shiseidou Tomita Hospital

Saitama, Saitama, Japan

Takahashi Clinic

Saitama, Saitama, Japan

Genkikai Wakasa Clinic

Tokorozawa, Saitama, Japan

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu, Shizuoka, Japan

Shimoda Medical Center

Shimoda, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

DIC Utsunomiya Central Clinic

Utsunomiya, Tochigi, Japan

Nippori Clinic

Arakawa-ku, Tokyo, Japan

Eireikai Niwa Family Clinic

Chōfu, Tokyo, Japan

Keiyu Clinic

Chuo-ku, Tokyo, Japan

Nihonbashikabutocho Nakajima Clinic

Chuo-ku, Tokyo, Japan

Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Taiseikai Seikoudou Clinic

Edogawa-ku, Tokyo, Japan

Hirookai Kanbara Clinic

Koto-ku, Tokyo, Japan

Ono Medical Clinic

Koto-ku, Tokyo, Japan

Sawai Medical Clinic

Koto-ku, Tokyo, Japan

Shinsei-kai Kameido Ekimae Ckinic

Koto-ku, Tokyo, Japan

Shinseikai Kameido Minami-guchi Clinic

Koto-ku, Tokyo, Japan

Kamada Clinic

Mitaka, Tokyo, Japan

Mitaka Health Care Clinic

Mitaka, Tokyo, Japan

Murenosato Clinic

Mitaka, Tokyo, Japan

Shirayurikai Swing Bldg Nozaki Clinic

Musashino, Tokyo, Japan

Kenkoukan Suzuki Clinic

Ōta-ku, Tokyo, Japan

Keichikai Shimokitazawa Tomo Clinic

Setagaya-ku, Tokyo, Japan

Ishinkai Oda Clinic

Shinjuku-ku, Tokyo, Japan

Ryousyukai Kanauchi Medical Clinic

Shinjuku-ku, Tokyo, Japan

Shingakai MaO Clinic

Suginami-ku, Tokyo, Japan

Keiseikai Otsuka Kita-guchi Clinic

Toshima-ku, Tokyo, Japan

Fujino Clinic

Ube, Yamaguchi, Japan

Hirokai Higashikatsura Medical Clinic

Tsuru, Yamanashi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 25646296 (View on PubMed)

Other Identifiers

ACS1

Identifier Type: -

Identifier Source: org_study_id