Azilsartan Circadian and Sleep Pressure

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sogo Rinsho Médéfi Co., Ltd.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01762501
First received: December 18, 2012
Last updated: April 22, 2013
Last verified: January 2013
  Purpose

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 Intervention
Hypertension
Drug: Azilsartan
Drug: Amlodipine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Azilsartan Circadian and Sleep Pressure - the 1st Study

Resource links provided by NLM:


Further study details as provided by Sogo Rinsho Médéfi Co., Ltd.:

Primary Outcome Measures:
  • Change in nocturnal systolic blood pressure level [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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:
  • Efficacy [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    • Change in the absolute value in difference with targeted value* (15 percent) of nocturnal systolic blood pressure fall**
    • Change in nocturnal diastolic blood pressure level
    • Change in 24-hour mean systolic blood pressure level
    • Change in 24-hour mean diastolic blood pressure level
    • Change in urinary micro albumin excretion
    • Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
    • Change in high-sensitivity cardiac troponin T (hs-cTnT)
    • Change in fasting glucose
    • Change in insulin resistance index***

      • 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 *** Insulin resistance index = fasting insulin level x fasting glucose level / 405


Other Outcome Measures:
  • Safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

    Adverse event

    - For Safety Analysis Set (SAS), count the onset rate of adverse events in term from the start of treatment period (Week 0) to the end (Week 8) in each group



Estimated Enrollment: 700
Study Start Date: December 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azilsartan
Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Azilsartan
Azilsartan 20mg/day
Active Comparator: Amlodipine
Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Amlodipine
Amlodipine 5mg/day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762501

Contacts
Contact: Kazuo Kario 81-285-58-7538

  Hide Study Locations
Locations
Japan
Seikei-kai New Tokyo Hospital Recruiting
Matsudo, Chiba, Japan
Sanshukai Doi Internal Medicine Clinic Recruiting
Chikushino, Fukuoka, Japan
Junshinkai Nakamura Cardiovascular Clinic Recruiting
Itoshima, Fukuoka, Japan
Osaki Clinic Recruiting
Kitakyusyu, Fukuoka, Japan
Osamura Medical Clinic Recruiting
Kitakyusyu, Fukuoka, Japan
Adachi Unonaika Clinic Withdrawn
Kitakyusyu, Fukuoka, Japan
Hoshi General Hospital Recruiting
Koriyama, Fukushima, Japan
Zensyukai Hospital Recruiting
Maebashi, Gunma, Japan
Koushinkai Shintomi Naika Clinic Recruiting
Asahikawa, Hokkaido, Japan
Hakushoukai Sano Hospital Recruiting
Asahikawa, Hokkaido, Japan
Jiseikai Higashiasahikawa Hospital Recruiting
Asahikawa, Hokkaido, Japan
Pieta-kai Ishikari Hospital Withdrawn
Ishikari, Hokkaido, Japan
Mitani Clinic Recruiting
Sapporo, Hokkaido, Japan
Aoki Clinic Recruiting
Sapporo, Hokkaido, Japan
Tokoharu Touei Hospital Withdrawn
Sapporo, Hokkaido, Japan
Shinkotoni Family Clinic Recruiting
Sapporo, Hokkaido, Japan
Houwakai Sapporo Hospital Recruiting
Sapporo, Hokkaido, Japan
Shoureikan Shinsapporo Seiryou Hospital Recruiting
Sapporo, Hokkaido, Japan
Kojinkai Kita13 Internal and Dermatology Clinic Withdrawn
Sapporo, Hokkaido, Japan
Tomakomai City Hospital Recruiting
Tomakomai, Hokkaido, Japan
Keiseikai Gohshi Hospital Recruiting
Amagasaki, Hyogo, Japan
Keijukai Itabashi Clinic Recruiting
Koga, Ibaraki, Japan
Koyokai Hanamure Hospital Recruiting
Ichikikushikino, Kagoshima, Japan
Izumi General Medical Center Recruiting
Izumi, Kagoshima, Japan
Kashiwagi Clinic Withdrawn
Ayase, Kanagawa, Japan
Iroden Clinic Recruiting
Kamakura, Kanagawa, Japan
Nagasu Clinic Recruiting
Kamakura, Kanagawa, Japan
Ota General Hospital Withdrawn
Kawasaki, Kanagawa, Japan
Himawari-kai Kanagawa Himawari Clinic Recruiting
Kawasaki, Kanagawa, Japan
Wakoukai Kawasaki Rinko General Hospital Recruiting
Kawasaki, Kanagawa, Japan
Yamamoto Clinic Recruiting
Sagamihara, Kanagawa, Japan
Hakuai Clinic Recruiting
Sagamihara, Kanagawa, Japan
Kaneshiro Diabetes Clinic Recruiting
Sagamihara, Kanagawa, Japan
Tsuruma Kaneshiro Diabetes Clinic Recruiting
Yamato, Kanagawa, Japan
Shintoukai Yokohama Minoru Clinic Recruiting
Yokohama, Kanagawa, Japan
Minamisawa Clinic Recruiting
Yokohama, Kanagawa, Japan
Furuie Clinic Recruiting
Yokohama, Kanagawa, Japan
Tani Clinic Recruiting
Yokohama, Kanagawa, Japan
Shuyu-kai Kikuchi Clinic Recruiting
Yokohama, Kanagawa, Japan
Shinwakai Fukuda Clinic Withdrawn
Yokohama, Kanagawa, Japan
Iwasaki Naika Clinic Withdrawn
Yokohama, Kanagawa, Japan
Shinden Higashi Clinic Recruiting
Sendai, Miyagi, Japan
Akimoto Clinic Withdrawn
Sendai, Miyagi, Japan
Higashikatsuyama Nakazawa Naika Allergy Internal Medicine Recruiting
Sendai, Miyagi, Japan
Shoninkai Shonin Hospital Recruiting
Beppu, Oita, Japan
Hirano Doujinkai Tsuyama Daiichi Hospital Recruiting
Tsuyama, Okayama, Japan
Taira Hospital Recruiting
Wake-gun, Okayama, Japan
Tenjin Tanaka Internal Medicine Clinic Recruiting
Takatsuki, Osaka, Japan
Enomoto Clinic Recruiting
Ageo, Saitama, Japan
Sankokai Satsuki Clinic Withdrawn
Hiki-gun, Saitama, Japan
Kazo Minami Clinic Recruiting
Kazo, Saitama, Japan
Shibuya Clinic Recruiting
Kumagaya, Saitama, Japan
Sekishinkai Sayama Sogo Clinic Withdrawn
Sayama, Saitama, Japan
Genkikai Wakasa Clinic Recruiting
Tokorozawa, Saitama, Japan
JA Shizuoka Kohseiren Enshu Hospital Recruiting
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital Recruiting
Shimotsuke, Tochigi, Japan
DIC Utsunomiya Central Clinic Recruiting
Utsunomiya, Tochigi, Japan
Yoseikai Masuda Clinic Withdrawn
Adachi-ku, Tokyo, Japan
Eireikai Niwa Family Clinic Recruiting
Chofu, Tokyo, Japan
Tokyo Center Clinic Recruiting
Chuo-ku, Tokyo, Japan
Nihonbashikabutocho Nakajima Clinic Recruiting
Chuo-ku, Tokyo, Japan
Taiseikai Seikoudou Clinic Recruiting
Edogawa-ku, Tokyo, Japan
Nihon University Itabashi Hospital Withdrawn
Itabashi-ku, Tokyo, Japan
Marumo Clinic Withdrawn
Koganei, Tokyo, Japan
Kainuma Clinic Withdrawn
Kokubunji, Tokyo, Japan
Shinseikai Kameido Minami-guchi Clinic Recruiting
Koto-ku, Tokyo, Japan
Hirookai Kanbara Clinic Recruiting
Koto-ku, Tokyo, Japan
Ono Medical Clinic Recruiting
Koto-ku, Tokyo, Japan
Sawai Medical Clinic Recruiting
Koto-ku, Tokyo, Japan
Kamada Clinic Recruiting
Mitaka, Tokyo, Japan
Murenosato Clinic Recruiting
Mitaka, Tokyo, Japan
Keishinkai Tenjinmae Clinic Withdrawn
Mitaka, Tokyo, Japan
Mitaka Health Care Clinic Recruiting
Mitaka, Tokyo, Japan
Shirayurikai Towers Naika Clinic Withdrawn
Musashino, Tokyo, Japan
Shirayurikai Swing Bldg Nozaki Clinic Recruiting
Musashino, Tokyo, Japan
Seishinkai Mugishima Clinic Withdrawn
Nerima-ku, Tokyo, Japan
Kenkoukan Suzuki Clinic Recruiting
Ota-ku, Tokyo, Japan
Keichikai Shimokitazawa Tomo Clinic Recruiting
Setagaya-ku, Tokyo, Japan
Ishinkai Oda Clinic Recruiting
Shinjuku-ku, Tokyo, Japan
Ryousyukai Kanauchi Medical Clinic Recruiting
Shinjuku-ku, Tokyo, Japan
Shingakai MaO Clinic Recruiting
Suginami-ku, Tokyo, Japan
Sugamo Clinic Withdrawn
Toshima-ku, Tokyo, Japan
Keiseikai Otsuka Kita-guchi Clinic Recruiting
Toshima-ku, Tokyo, Japan
Fujino Clinic Recruiting
Ube, Yamaguchi, Japan
Hirokai Higashikatsura Medical Clinic Recruiting
Tsuru, Yamanashi, Japan
THY Tokuyama Clinic Withdrawn
Chiba, Japan
Hakataeki-higashi Clinic Recruiting
Fukuoka, Japan
Ogata Medical Clinic Recruiting
Fukuoka, Japan
Soejima Naika Clinic Recruiting
Fukuoka, Japan
Harada Clinic Withdrawn
Fukuoka, Japan
Masuda Clinic Withdrawn
Fukuoka, Japan
Takamibaba Yamaguchi Clinic Withdrawn
Kagoshima, Japan
Yasuda Clinic Recruiting
Okayama, Japan
Seizenkai Okayama Saidaiji Hospital Recruiting
Okayama, Japan
Kouseikai Chimori Medical Clinic Recruiting
Osaka, Japan
Takahashi Clinic Recruiting
Saitama, Japan
Shiseidou Tomita Hospital Recruiting
Saitama, Japan
H&Y Akimoto Naika Clinic Recruiting
Saitama, Japan
Sponsors and Collaborators
Sogo Rinsho Médéfi Co., Ltd.
Takeda
  More Information

No publications provided

Responsible Party: Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier: NCT01762501     History of Changes
Other Study ID Numbers: ACS1
Study First Received: December 18, 2012
Last Updated: April 22, 2013
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 21, 2014