Azilsartan Circadian and Sleep Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01762501
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : December 28, 2015
Last Update Posted : December 28, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan Drug: Amlodipine Not Applicable

Detailed Description:


<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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 957 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Azilsartan Circadian and Sleep Pressure - the 1st Study
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Azilsartan
Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Azilsartan
Azilsartan 20mg/day
Other Name: AZILVA Tablets

Active Comparator: Amlodipine
Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Amlodipine
Amlodipine 5mg/day
Other Name: Amlodin Tablets etc.

Primary Outcome Measures :
  1. Change in Nocturnal Systolic Blood Pressure Level [ Time Frame: 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 :
  1. Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** [ Time Frame: 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 SBP

  2. Change in Nocturnal Diastolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

  3. Change in 24-hour Mean Systolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

  4. Change in 24-hour Mean Diastolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01762501

  Hide Study Locations
Jyuzen General Hospital
Niihama, Aichi, Japan
Junn Clinic
Tsushima, Aichi, Japan
Seikei-kai New Tokyo Hospital
Matsudo, Chiba, Japan
Sanshukai Doi Internal Medicine Clinic
Chikushino, Fukuoka, Japan
Junshinkai Nakamura Cardiovascular Clinic
Itoshima, Fukuoka, Japan
Osaki Clinic
Kitakyusyu, Fukuoka, Japan
Osamura Medical Clinic
Kitakyusyu, Fukuoka, Japan
Hoshi General Hospital
Koriyama, Fukushima, Japan
Zensyukai Hospital
Maebashi, Gunma, 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
Hukuyo naika clinic
Itoshima, Hukuoka, Japan
Asunaro medical Clinic
Kitakyushu, Hukuoka, Japan
Keiseikai Gohshi Hospital
Amagasaki, Hyogo, Japan
Keijukai Itabashi Clinic
Koga, Ibaraki, Japan
Kamata medical Clinic
Morioka, Iwate, Japan
Koyokai Hanamure Hospital
Ichikikushikino, Kagoshima, Japan
Izumi General Medical Center
Izumi, Kagoshima, 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
Meiwakai Izaki Clinic
Omura, Nagasaki, Japan
Shoninkai Shonin Hospital
Beppu, Oita, Japan
Hirano Doujinkai Tsuyama Daiichi Hospital
Tsuyama, Okayama, Japan
Taira Hospital
Wake-gun, Okayama, 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
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
Chofu, 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
Ota-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
Hakataeki-higashi Clinic
Fukuoka, Japan
Ogata Medical Clinic
Fukuoka, Japan
Soejima Naika Clinic
Fukuoka, Japan
Inoue Neurology Clinic
Hiroshima, Japan
Oda medical Clinic
Hiroshima, Japan
Aiseikai PS Clinic
Hukuoka, Japan
Kosei-kai Nijigaoka Hospital
Nagasaki, Japan
Seizenkai Okayama Saidaiji Hospital
Okayama, Japan
Yasuda Clinic
Okayama, Japan
AMC Nishiumeda Clinic
Osaka, Japan
Kouseikai Chimori Medical Clinic
Osaka, Japan
H&Y Akimoto Naika Clinic
Saitama, Japan
Shiseidou Tomita Hospital
Saitama, Japan
Takahashi Clinic
Saitama, Japan
Sponsors and Collaborators
Sogo Rinsho Médéfi Co., Ltd.
Principal Investigator: Kazuo Kario Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sogo Rinsho Médéfi Co., Ltd. Identifier: NCT01762501     History of Changes
Other Study ID Numbers: ACS1
First Posted: January 7, 2013    Key Record Dates
Results First Posted: December 28, 2015
Last Update Posted: December 28, 2015
Last Verified: November 2015

Keywords provided by Sogo Rinsho Médéfi Co., Ltd.:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents