Azilsartan Circadian and Sleep Pressure

Hypertension Clinical Trial

Official title:

Azilsartan Circadian and Sleep Pressure - the 1st Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762501
• Other study ID #: ACS1
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: November 19, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Sogo Rinsho Médéfi Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical 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.

Description:

Treatment

Use of any antihypertensives, including azilsartan and amlodipine, is prohibited during the run-in 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 information / eligibility

• Status: Completed
• Enrollment: 957
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Azilsartan
Azilsartan 20mg/day
• Amlodipine
Amlodipine 5mg/day

Locations

Country	Name	City	State
Japan	Enomoto Clinic	Ageo	Saitama
Japan	Keiseikai Gohshi Hospital	Amagasaki	Hyogo
Japan	Nippori Clinic	Arakawa-ku	Tokyo
Japan	Hakushoukai Sano Hospital	Asahikawa	Hokkaido
Japan	Jiseikai Higashiasahikawa Hospital	Asahikawa	Hokkaido
Japan	Koushinkai Shintomi Naika Clinic	Asahikawa	Hokkaido
Japan	Shoninkai Shonin Hospital	Beppu	Oita
Japan	Sanshukai Doi Internal Medicine Clinic	Chikushino	Fukuoka
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	Hakataeki-higashi Clinic	Fukuoka
Japan	Ogata Medical Clinic	Fukuoka
Japan	Soejima Naika Clinic	Fukuoka
Japan	JA Shizuoka Kohseiren Enshu Hospital	Hamamatsu	Shizuoka
Japan	Inoue Neurology Clinic	Hiroshima
Japan	Oda medical Clinic	Hiroshima
Japan	Aiseikai PS Clinic	Hukuoka
Japan	Koyokai Hanamure Hospital	Ichikikushikino	Kagoshima
Japan	Hukuyo naika clinic	Itoshima	Hukuoka
Japan	Junshinkai Nakamura Cardiovascular Clinic	Itoshima	Fukuoka
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	Kazo Minami Clinic	Kazo	Saitama
Japan	Asunaro medical Clinic	Kitakyushu	Hukuoka
Japan	Osaki Clinic	Kitakyusyu	Fukuoka
Japan	Osamura Medical Clinic	Kitakyusyu	Fukuoka
Japan	Keijukai Itabashi Clinic	Koga	Ibaraki
Japan	Hoshi General Hospital	Koriyama	Fukushima
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	Asukurepiosu Enomoto Clinic	Kumagaya	Saitama
Japan	Shibuya Clinic	Kumagaya	Saitama
Japan	Zensyukai Hospital	Maebashi	Gunma
Japan	Seikei-kai New Tokyo Hospital	Matsudo	Chiba
Japan	Kamada Clinic	Mitaka	Tokyo
Japan	Mitaka Health Care Clinic	Mitaka	Tokyo
Japan	Murenosato Clinic	Mitaka	Tokyo
Japan	Kamata medical Clinic	Morioka	Iwate
Japan	Shirayurikai Swing Bldg Nozaki Clinic	Musashino	Tokyo
Japan	Kosei-kai Nijigaoka Hospital	Nagasaki
Japan	Jyuzen General Hospital	Niihama	Aichi
Japan	Seizenkai Okayama Saidaiji Hospital	Okayama
Japan	Yasuda Clinic	Okayama
Japan	Meiwakai Izaki Clinic	Omura	Nagasaki
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Kouseikai Chimori Medical Clinic	Osaka
Japan	Kenkoukan Suzuki Clinic	Ota-ku	Tokyo
Japan	Hakuai Clinic	Sagamihara	Kanagawa
Japan	Kaneshiro Diabetes Clinic	Sagamihara	Kanagawa
Japan	Yamamoto Clinic	Sagamihara	Kanagawa
Japan	H&Y Akimoto Naika Clinic	Saitama
Japan	Shiseidou Tomita Hospital	Saitama
Japan	Takahashi Clinic	Saitama
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	Higashikatsuyama Nakazawa Naika Allergy Internal Medicine	Sendai	Miyagi
Japan	Shinden Higashi Clinic	Sendai	Miyagi
Japan	Keichikai Shimokitazawa Tomo Clinic	Setagaya-ku	Tokyo
Japan	Shimoda Medical Center	Shimoda	Shizuoka
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Ishinkai Oda Clinic	Shinjuku-ku	Tokyo
Japan	Ryousyukai Kanauchi Medical Clinic	Shinjuku-ku	Tokyo
Japan	Shingakai MaO Clinic	Suginami-ku	Tokyo
Japan	Tenjin Tanaka Internal Medicine Clinic	Takatsuki	Osaka
Japan	Genkikai Wakasa Clinic	Tokorozawa	Saitama
Japan	Tomakomai City Hospital	Tomakomai	Hokkaido
Japan	Keiseikai Otsuka Kita-guchi Clinic	Toshima-ku	Tokyo
Japan	Hirokai Higashikatsura Medical Clinic	Tsuru	Yamanashi
Japan	Junn Clinic	Tsushima	Aichi
Japan	Hirano Doujinkai Tsuyama Daiichi Hospital	Tsuyama	Okayama
Japan	Fujino Clinic	Ube	Yamaguchi
Japan	DIC Utsunomiya Central Clinic	Utsunomiya	Tochigi
Japan	Taira Hospital	Wake-gun	Okayama
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

Sponsors (2)

Lead Sponsor	Collaborator
Sogo Rinsho Médéfi Co., Ltd.	Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline and 8 weeks	No
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	Baseline and 8 weeks	No
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)	Baseline and 8 weeks	No
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)	Baseline and 8 weeks	No
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)	Baseline and 8 weeks	No