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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan | Experimental | Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks |
|
| Amlodipine | Active Comparator | Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan | Drug | Azilsartan 20mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Kazuo Kario | Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jyuzen General Hospital | Niihama | Aichi-ken | Japan | |||
| Junn Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25646296 | Derived | 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. |
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957 patients was enrolled in this study. In run-in period, 239 patients were withdrawn.
Enrollment was performed at hospital and clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan | Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day |
| FG001 | Amlodipine | Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amlodipine | Drug | Amlodipine 5mg/day |
|
|
| Baseline and 8 weeks |
| Change in Nocturnal Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks |
| Change in 24-hour Mean Systolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks |
| Change in 24-hour Mean Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan | Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day |
| BG001 | Amlodipine | Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Clinic SBP | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Clinic DBP | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| 24-hour SBP | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| 24-hour DBP | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | mmHg | Baseline and 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | 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 | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Nocturnal Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Posted | Mean | Standard Deviation | mmHg | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Mean Systolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Posted | Mean | Standard Deviation | mmHg | Baseline and 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Mean Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Posted | Mean | Standard Deviation | mmHg | Baseline and 8 weeks |
|
|
8weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azilsartan | Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks Azilsartan: Azilsartan 20mg/day | 0 | 359 | 91 | 359 | ||
| EG001 | Amlodipine | Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks Amlodipine: Amlodipine 5mg/day | 5 | 359 | 77 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stroke | Vascular disorders | Non-systematic Assessment |
| ||
| Nettle rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Cancer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious disease | Infections and infestations | Non-systematic Assessment |
| ||
| Other | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
The only disclosure restriction on the PIs is that PIs must get approval about publish by study director(Kazuo Kario).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naoyuki Takano | Sogo Rinsho Medefi Co., Ltd | +81-3-6901-6079 | takano.naoyuki@sogo-medefi.jp |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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