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HypertensionNCT01762501

Azilsartan Circadian and Sleep Pressure

A study testing Azilsartan and Amlodipine in people with Hypertension, run by Sogo Rinsho Médéfi Co., Ltd. at 92 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hypertension
What is being tested?
Azilsartan and Amlodipine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
957 participants
Where
92 sitesJapan
Study dates
Dec 2012to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • 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.
Show all 15Show fewer
  • History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period.
  • 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

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

Japan92 sites

  • Enomoto Clinic

    Ageo, Saitama

  • Keiseikai Gohshi Hospital

    Amagasaki, Hyōgo

  • Nippori Clinic

    Arakawa-ku, Tokyo

  • Hakushoukai Sano Hospital

    Asahikawa, Hokkaido

  • Jiseikai Higashiasahikawa Hospital

    Asahikawa, Hokkaido

  • Koushinkai Shintomi Naika Clinic

    Asahikawa, Hokkaido

  • Shoninkai Shonin Hospital

    Beppu, Oita Prefecture

  • Sanshukai Doi Internal Medicine Clinic

    Chikushino-shi, Fukuoka

  • Eireikai Niwa Family Clinic

    Chōfu, Tokyo

  • Keiyu Clinic

    Chuo-ku, Tokyo

  • Nihonbashikabutocho Nakajima Clinic

    Chuo-ku, Tokyo

  • Tokyo Center Clinic

    Chuo-ku, Tokyo

  • Taiseikai Seikoudou Clinic

    Edogawa-ku, Tokyo

  • Hakataeki-higashi Clinic

    Fukuoka, Fukuoka

  • Ogata Medical Clinic

    Fukuoka, Fukuoka

  • Soejima Naika Clinic

    Fukuoka, Fukuoka

  • Aiseikai PS Clinic

    Fukuoka, Hukuoka

  • JA Shizuoka Kohseiren Enshu Hospital

    Hamamatsu, Shizuoka

  • Inoue Neurology Clinic

    Hiroshima, Hiroshima

  • Oda medical Clinic

    Hiroshima, Hiroshima

  • Koyokai Hanamure Hospital

    Ichikikushikino, Kagoshima-ken

  • Junshinkai Nakamura Cardiovascular Clinic

    Itoshima, Fukuoka

  • Hukuyo naika clinic

    Itoshima, Hukuoka

  • Izumi General Medical Center

    Izumi, Kagoshima-ken

  • Iroden Clinic

    Kamakura, Kanagawa

  • Nagasu Clinic

    Kamakura, Kanagawa

  • Himawari-kai Kanagawa Himawari Clinic

    Kawasaki, Kanagawa

  • Kawasaki Saiwai Clinic

    Kawasaki, Kanagawa

  • Wakoukai Kawasaki Rinko General Hospital

    Kawasaki, Kanagawa

  • Kazo Minami Clinic

    Kazo, Saitama

  • Osaki Clinic

    Kitakyushu, Fukuoka

  • Osamura Medical Clinic

    Kitakyushu, Fukuoka

  • Asunaro medical Clinic

    Kitakyushu, Hukuoka

  • Keijukai Itabashi Clinic

    Koga, Ibaraki

  • Hoshi General Hospital

    Kōriyama, Fukushima

  • Hirookai Kanbara Clinic

    Koto-ku, Tokyo

  • Ono Medical Clinic

    Koto-ku, Tokyo

  • Sawai Medical Clinic

    Koto-ku, Tokyo

  • Shinsei-kai Kameido Ekimae Ckinic

    Koto-ku, Tokyo

  • Shinseikai Kameido Minami-guchi Clinic

    Koto-ku, Tokyo

  • Asukurepiosu Enomoto Clinic

    Kumagaya, Saitama

  • Shibuya Clinic

    Kumagaya, Saitama

  • Zensyukai Hospital

    Maebashi, Gunma

  • Seikei-kai New Tokyo Hospital

    Matsudo, Chiba

  • Kamada Clinic

    Mitaka, Tokyo

  • Mitaka Health Care Clinic

    Mitaka, Tokyo

  • Murenosato Clinic

    Mitaka, Tokyo

  • Kamata medical Clinic

    Morioka, Iwate

  • Shirayurikai Swing Bldg Nozaki Clinic

    Musashino, Tokyo

  • Kosei-kai Nijigaoka Hospital

    Nagasaki, Nagasaki

  • Jyuzen General Hospital

    Niihama, Aichi-ken

  • Seizenkai Okayama Saidaiji Hospital

    Okayama, Okayama-ken

  • Yasuda Clinic

    Okayama, Okayama-ken

  • Meiwakai Izaki Clinic

    Ōmura, Nagasaki

  • AMC Nishiumeda Clinic

    Osaka, Osaka

  • Kouseikai Chimori Medical Clinic

    Osaka, Osaka

  • Kenkoukan Suzuki Clinic

    Ōta-ku, Tokyo

  • Hakuai Clinic

    Sagamihara, Kanagawa

  • Kaneshiro Diabetes Clinic

    Sagamihara, Kanagawa

  • Yamamoto Clinic

    Sagamihara, Kanagawa

  • H&Y Akimoto Naika Clinic

    Saitama, Saitama

  • Shiseidou Tomita Hospital

    Saitama, Saitama

  • Takahashi Clinic

    Saitama, Saitama

  • Aoki Clinic

    Sapporo, Hokkaido

  • Houwakai Sapporo Hospital

    Sapporo, Hokkaido

  • Mitani Clinic

    Sapporo, Hokkaido

  • Shinkotoni Family Clinic

    Sapporo, Hokkaido

  • Shoureikan Shinsapporo Seiryou Hospital

    Sapporo, Hokkaido

  • Higashikatsuyama Nakazawa Naika Allergy Internal Medicine

    Sendai, Miyagi

  • Shinden Higashi Clinic

    Sendai, Miyagi

  • Keichikai Shimokitazawa Tomo Clinic

    Setagaya-ku, Tokyo

  • Shimoda Medical Center

    Shimoda, Shizuoka

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi

  • Ishinkai Oda Clinic

    Shinjuku-ku, Tokyo

  • Ryousyukai Kanauchi Medical Clinic

    Shinjuku-ku, Tokyo

  • Shingakai MaO Clinic

    Suginami-ku, Tokyo

  • Tenjin Tanaka Internal Medicine Clinic

    Takatsuki, Osaka

  • Genkikai Wakasa Clinic

    Tokorozawa, Saitama

  • Tomakomai City Hospital

    Tomakomai, Hokkaido

  • Keiseikai Otsuka Kita-guchi Clinic

    Toshima-ku, Tokyo

  • Hirokai Higashikatsura Medical Clinic

    Tsuru, Yamanashi

  • Junn Clinic

    Tsushima, Aichi-ken

  • Hirano Doujinkai Tsuyama Daiichi Hospital

    Tsuyama, Okayama-ken

  • Fujino Clinic

    Ube, Yamaguchi

  • DIC Utsunomiya Central Clinic

    Utsunomiya, Tochigi

  • Taira Hospital

    Wake-gun, Okayama-ken

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato, Kanagawa

  • Furuie Clinic

    Yokohama, Kanagawa

  • Minamisawa Clinic

    Yokohama, Kanagawa

  • Shintoukai Yokohama Minoru Clinic

    Yokohama, Kanagawa

  • Shuyu-kai Kikuchi Clinic

    Yokohama, Kanagawa

  • Tani Clinic

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Azilsartan Circadian and Sleep Pressure - the 1st Study

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.

Read the 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
Being tested
Azilsartan, Amlodipine
Keywords
Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzilsartanDrug

    Also called AZILVA Tablets

    Azilsartan 20mg/day

  • AmlodipineDrug

    Also called Amlodin Tablets etc.

    Amlodipine 5mg/day

Study groups in NCT01762501
Study groupRoleWhat they receive
AzilsartanExperimentalAzilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Receives: Drug: Azilsartan
AmlodipineActive comparatorAmlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Receives: Drug: Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline and 8 weeks

Secondary outcomes (4)

  1. 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

    Measured: Baseline and 8 weeks

  2. 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)

    Measured: Baseline and 8 weeks

  3. 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)

    Measured: Baseline and 8 weeks

  4. 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)

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
957 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762501
Sponsor's protocol ID
ACS1
Status last verified
Nov 2015
First submitted
18 Dec 2012
Last updated
28 Dec 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 25646296

Questions about this trial

What is this clinical trial studying?

A study testing Azilsartan and Amlodipine in people with Hypertension, run by Sogo Rinsho Médéfi Co., Ltd. at 92 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Nocturnal Systolic Blood Pressure Level (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01762501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.

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