Azilsartan Circadian and Sleep Pressure
- Registration Number
- NCT01762501
- Lead Sponsor
- Sogo Rinsho Médéfi Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 957
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlodipine Amlodipine Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan Azilsartan Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 SBPChange 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)
Trial Locations
- Locations (92)
Seikei-kai New Tokyo Hospital
🇯🇵Matsudo, Chiba, Japan
Hoshi General Hospital
🇯🇵Koriyama, Fukushima, Japan
Keijukai Itabashi Clinic
🇯🇵Koga, Ibaraki, Japan
Koyokai Hanamure Hospital
🇯🇵Ichikikushikino, Kagoshima, Japan
Hakuai Clinic
🇯🇵Sagamihara, Kanagawa, Japan
Nagasu Clinic
🇯🇵Kamakura, Kanagawa, Japan
Meiwakai Izaki Clinic
🇯🇵Omura, Nagasaki, Japan
Furuie Clinic
🇯🇵Yokohama, Kanagawa, Japan
Keichikai Shimokitazawa Tomo Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Shingakai MaO Clinic
🇯🇵Suginami-ku, Tokyo, Japan
AMC Nishiumeda Clinic
🇯🇵Osaka, Japan
Kouseikai Chimori Medical Clinic
🇯🇵Osaka, Japan
Osaki Clinic
🇯🇵Kitakyusyu, Fukuoka, Japan
Zensyukai Hospital
🇯🇵Maebashi, Gunma, Japan
Aoki Clinic
🇯🇵Sapporo, Hokkaido, Japan
Shoureikan Shinsapporo Seiryou Hospital
🇯🇵Sapporo, Hokkaido, Japan
Asunaro medical Clinic
🇯🇵Kitakyushu, Hukuoka, Japan
Izumi General Medical Center
🇯🇵Izumi, Kagoshima, Japan
Kamata medical Clinic
🇯🇵Morioka, Iwate, Japan
Iroden Clinic
🇯🇵Kamakura, Kanagawa, Japan
Kaneshiro Diabetes Clinic
🇯🇵Sagamihara, Kanagawa, Japan
Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato, Kanagawa, Japan
Kawasaki Saiwai Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Wakoukai Kawasaki Rinko General Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Shintoukai Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Shuyu-kai Kikuchi Clinic
🇯🇵Yokohama, Kanagawa, Japan
Higashikatsuyama Nakazawa Naika Allergy Internal Medicine
🇯🇵Sendai, Miyagi, Japan
Shinden Higashi Clinic
🇯🇵Sendai, Miyagi, Japan
Enomoto Clinic
🇯🇵Ageo, Saitama, Japan
Shoninkai Shonin Hospital
🇯🇵Beppu, Oita, Japan
Shimoda Medical Center
🇯🇵Shimoda, Shizuoka, Japan
Kosei-kai Nijigaoka Hospital
🇯🇵Nagasaki, Japan
Shiseidou Tomita Hospital
🇯🇵Saitama, Japan
Jyuzen General Hospital
🇯🇵Niihama, Aichi, Japan
Sanshukai Doi Internal Medicine Clinic
🇯🇵Chikushino, Fukuoka, Japan
Junshinkai Nakamura Cardiovascular Clinic
🇯🇵Itoshima, Fukuoka, Japan
Osamura Medical Clinic
🇯🇵Kitakyusyu, Fukuoka, Japan
Junn Clinic
🇯🇵Tsushima, Aichi, Japan
Hakushoukai Sano Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Jiseikai Higashiasahikawa Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Koushinkai Shintomi Naika Clinic
🇯🇵Asahikawa, Hokkaido, Japan
Tomakomai City Hospital
🇯🇵Tomakomai, Hokkaido, Japan
Houwakai Sapporo Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hukuyo naika clinic
🇯🇵Itoshima, Hukuoka, Japan
Mitani Clinic
🇯🇵Sapporo, Hokkaido, Japan
Shinkotoni Family Clinic
🇯🇵Sapporo, Hokkaido, Japan
Keiseikai Gohshi Hospital
🇯🇵Amagasaki, Hyogo, Japan
Himawari-kai Kanagawa Himawari Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Yamamoto Clinic
🇯🇵Sagamihara, Kanagawa, Japan
Tani Clinic
🇯🇵Yokohama, Kanagawa, Japan
Minamisawa Clinic
🇯🇵Yokohama, Kanagawa, Japan
Tenjin Tanaka Internal Medicine Clinic
🇯🇵Takatsuki, Osaka, Japan
Taira Hospital
🇯🇵Wake-gun, Okayama, Japan
Hirano Doujinkai Tsuyama Daiichi Hospital
🇯🇵Tsuyama, Okayama, Japan
Kazo Minami Clinic
🇯🇵Kazo, Saitama, Japan
JA Shizuoka Kohseiren Enshu Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Asukurepiosu Enomoto Clinic
🇯🇵Kumagaya, Saitama, Japan
Nippori Clinic
🇯🇵Arakawa-ku, Tokyo, Japan
Shibuya Clinic
🇯🇵Kumagaya, Saitama, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
DIC Utsunomiya Central Clinic
🇯🇵Utsunomiya, Tochigi, Japan
Nihonbashikabutocho Nakajima Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Hirookai Kanbara Clinic
🇯🇵Koto-ku, Tokyo, Japan
Taiseikai Seikoudou Clinic
🇯🇵Edogawa-ku, Tokyo, Japan
Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Kamada Clinic
🇯🇵Mitaka, Tokyo, Japan
Ono Medical Clinic
🇯🇵Koto-ku, Tokyo, Japan
Shinsei-kai Kameido Ekimae Ckinic
🇯🇵Koto-ku, Tokyo, Japan
Sawai Medical Clinic
🇯🇵Koto-ku, Tokyo, Japan
Shinseikai Kameido Minami-guchi Clinic
🇯🇵Koto-ku, Tokyo, Japan
Ryousyukai Kanauchi Medical Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Keiseikai Otsuka Kita-guchi Clinic
🇯🇵Toshima-ku, Tokyo, Japan
Aiseikai PS Clinic
🇯🇵Hukuoka, Japan
Fujino Clinic
🇯🇵Ube, Yamaguchi, Japan
Hakataeki-higashi Clinic
🇯🇵Fukuoka, Japan
Hirokai Higashikatsura Medical Clinic
🇯🇵Tsuru, Yamanashi, Japan
Ogata Medical Clinic
🇯🇵Fukuoka, Japan
Inoue Neurology Clinic
🇯🇵Hiroshima, Japan
Oda medical Clinic
🇯🇵Hiroshima, Japan
Soejima Naika Clinic
🇯🇵Fukuoka, Japan
Seizenkai Okayama Saidaiji Hospital
🇯🇵Okayama, Japan
Yasuda Clinic
🇯🇵Okayama, Japan
Takahashi Clinic
🇯🇵Saitama, Japan
Genkikai Wakasa Clinic
🇯🇵Tokorozawa, Saitama, Japan
H&Y Akimoto Naika Clinic
🇯🇵Saitama, Japan
Mitaka Health Care Clinic
🇯🇵Mitaka, Tokyo, Japan
Kenkoukan Suzuki Clinic
🇯🇵Ota-ku, Tokyo, Japan
Keiyu Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Murenosato Clinic
🇯🇵Mitaka, Tokyo, Japan
Shirayurikai Swing Bldg Nozaki Clinic
🇯🇵Musashino, Tokyo, Japan
Eireikai Niwa Family Clinic
🇯🇵Chofu, Tokyo, Japan
Ishinkai Oda Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan