Azilsartan Circadian and Sleep Pressure
1 other identifier
interventional
957
1 country
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Dec 2012
Shorter than P25 for not_applicable hypertension
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
December 28, 2015
CompletedDecember 28, 2015
November 1, 2015
1 year
December 18, 2012
November 19, 2015
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and 8 weeks
Secondary Outcomes (4)
Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**
Baseline and 8 weeks
Change in Nocturnal Diastolic Blood Pressure Level
Baseline and 8 weeks
Change in 24-hour Mean Systolic Blood Pressure Level
Baseline and 8 weeks
Change in 24-hour Mean Diastolic Blood Pressure Level
Baseline and 8 weeks
Study Arms (2)
Azilsartan
EXPERIMENTALAzilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine
ACTIVE COMPARATORAmlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sogo Rinsho Médéfi Co., Ltd.lead
- Takedacollaborator
Study Sites (92)
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
Related Publications (1)
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.
PMID: 25646296DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naoyuki Takano
- Organization
- Sogo Rinsho Medefi Co., Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuo Kario
Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
January 7, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 28, 2015
Results First Posted
December 28, 2015
Record last verified: 2015-11