Unique ID issued by UMIN | UMIN000016629 |
---|---|
Receipt number | R000018555 |
Scientific Title | Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics |
Date of disclosure of the study information | 2015/02/25 |
Last modified on | 2018/01/15 16:03:41 |
Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics
NOCTURNE study
Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics
NOCTURNE study
Japan |
Hypertension
Cardiology |
Others
NO
Comparison of the effects by two fixed dose combination drugs, the angiotension receptor blocler(ARB:irbesartan) with calcium channel blocker(CCB:amlodipine) or diuretics(trichlormethiazide), on nocturnal blood pressure and target organ damage in hypertensive patients.
Safety,Efficacy
Changes in nocturnal systolic blood pressure(SBP) at home from 4 to 12 weeks after study start
Parameters for efficacy:
Changes of following parameters from 4 to 12 weeks
・noctunrnal diastolic blood pressure (DBP) at home
・waking and bedtime SBP/DBP at home
・SBP/DBP in seated and standing position at office
・interday and circadian variabilities (SD) and pulse pressure of nocturnal, bedtime and waking SBP/DBP at home
・Achievement rate to the targeted hypotensive effects on nocturnal blood pressure at home (SBP<120mmHg and DBP <70mmHg)
・Achievement rate to the targeted BP in seated position at office on JSH2014 guideline
・NT-pro BNP
・urinary micro albumin
・Estimated Na excretion and Na/K ratio in urine
Parameters for safety
Safety such as adverse events including abnormal values in clinical examinations
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
(Interventions/ Control 1)
After 4weeks administration of irbesartan100mg/day, the participants are randomly allocated into the group; 8 weeks administration of irbesartan100mg/ amlodipine 5mg combination drug
(Interventions/ Control 2)
After 4weeks administration of irbesartan100mg/day, the participants are randomly allocated into the group; 8weeks administration of irbesartan100mg/ trichlormethiazide 1mg combination drug
30 | years-old | <= |
85 | years-old | > |
Male and Female
At interim registration:
Patients whose profiles are fulfilled with all of the following criterias will be included.
1) patients who give written consent to participation in the study at their own will
2) at the age of 30 years old or older and younger than 85 years old (at consent acquisition)
3) male or female (except females with possibility of pregnancy)
4) outpatient
5) hypertensive patients
Untreated patients*1 and patients*2 treated with antihypertensive drugs
*1:Patients with office BP >=140mmHg in SBP or 90mmHg in DBP ( home BP >=135mmHg in SBP or 85mmHg in DBP),
*2: Patients treated concomitantly with two drugs among ARB, CCB anddiuretics et al. (including fixed-dose combination drugs with two component) or single drug at doses less than ordinary doses instructed in the package inserts for Japanese
6) The patients who can accept irbesartan, trichlormethiazide and amlodipine
At the official registration
1)The patients whose mean nocturnal blood pressure measured during five days before hospital visiting at week4 are higher than SBP120mmHg or DBP70mmHg
Patient who concern the following criterias are excluded:
At interim registration:
1)patient in being treated with irbesartan
2) patient with severe kidney dysfunction(serum creatinine >= 2.0 mg/dL )
3) patient with severe liver dysfunction(incliding biliary cirrhosis or cholestasis band)
4) patient with severe heart failure(New York Heart Association(NYHA) functional class >=II M )
5)patient diagnosed the ischemic heart disease or stroke within the past 6 months before consent acquisition
6) patient with history of hypersensitivity to ARB, thiazide drugs ,CCB and these combination drugs
7) patient with hypokalemia(K<3.0mEq/L) or hyperkalemia(K>=5.5mEq/L)
8) patients with malignant tumor or the history of malignant tumor within the past 5 years before consent acquisition)
9) pregnant woman or woman with possibility of being pregnant.
10) patient with sleep apnea syndrome
11) patient with not-well controlled hypertension(SBP>=200mmHg or DBP>=120mmHg at office)
12) patient deemed ineligible by investigator
At official registration
1) patient who is deemed ineligible by investigator from implemental status in monitoring by the use of 3G-enabled BPM with MedicalLINK high blood management service during observation period
2) patient with serious adverse events during the observation period
3) patient deemed ineligible by investigator
400
1st name | |
Middle name | |
Last name | Kazuomi Kario |
Jichi Medical University School of Medicine
Division of Cardiovascular,Medicine, Department of Medicine
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
0285-58-7344
kkario@jichii.ac.jp
1st name | |
Middle name | |
Last name | NOCTURNE Research support Office |
NOCTURNE Research support Office
Satt Co., Ltd.
Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
03-5312-5026
nocturne@sa-tt.co.jp
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine/ SHIONOGI&CO.,LTD.
SHIONOGI&CO.,LTD.
Profit organization
NO
鶴谷病院(群馬県)
医療法人康成会 星和台クリニック(奈良県)
桂寿病院(大阪府)
医療法人社団 勝谷医院(兵庫県)
せいの内科クリニック(福島県)
岩崎病院(三重県)
医療法人旭友会 池田診療所(大阪府
わかさ内科クリニック(石川県)
しおのやクリニック(石川県)
田井内科クリニック(大阪府)
医療法人 近藤クリニック(大阪府)
戸早医院(福岡県)
倉井内科医院(東京都)
中野島北口コガワクリニック(神奈川県)
医療法人社団 幸正会 岩槻南病院(埼玉県)
医療法人慶和会 河野医院(宮崎県)
たに内科・糖尿病内科クリニック(福島県)
医療法人社団柳澤会 柳澤医院(千葉県)
医療法人社団 細田診療所(東京都)
あきやまクリニック(香川県)
きくち医院(神奈川県)
奥田クリニック(東京都)
自治医科大学附属病院(栃木県)
やまがみ内科医院(神奈川県)
内山医院(新潟県)
長洲クリニック(神奈川県)
せきぐちクリニック(東京都)
おがわ内科クリニック(愛知県)
医療法人社団森谷会 森谷医院(東京都)
前田内科医院(新潟県)
石手まつもと内科循環器クリニック(愛媛県)
平光ハートクリニック(愛知県)
佐野内科ハートクリニック(兵庫県)
西澤内科クリニック(東京都)
医療法人優雅 鶴間かねしろ内科クリニック(神奈川県)
医療法人優雅 東林間かねしろ内科クリニック(神奈川県)
志賀クリニック(石川県)
医療法人清和会 水前寺とうや病院(熊本県)
はせがわ内科クリニック(北海道)
医療法人松寿会 天保山内科(鹿児島県)
医療法人社団 勁心会 天神前クリニック(東京都)
玉木内科小児科クリニック(高知県)
山際クリニック(愛知県)
白岩内科医院(大阪府)
医療法人仁泉会 池浦クリニック (愛知県)
なぎさクリニック(大阪府)
林診療所(大阪府)
きむら内科クリニック(神奈川県)
のだ医院(岐阜県)
医療法人貴優会 高橋ファミリークリニック (愛知県)
公立岩瀬病院(福島県)
かしの木内科クリニック(福島県)
ひろさか内科クリニック(福島県)
南谷クリニック岡町本院(大阪府)
グランドタワーメディカルコートライフケアクリニック(広島県)
表参道内科眼科(東京都)
医療法人 西村クリニック(大阪府)
石黒クリニック(岐阜県)
こたに糖尿病内科クリニック(兵庫県)
横田内科(宮崎県)
赤心堂クリニック(東京都)
大和田内科胃腸科(栃木県)
武田クリニック(神奈川県)
医療法人社団銀河 雫石大森クリニック(岩手県)
江村胃腸科内科医院(岩手県)
おんが病院(福岡県)
大久保医院 (岐阜県)
富田内科循環器科クリニック(北海道)
たけざわ循環器科・内科クリニック(愛知県)
2015 | Year | 02 | Month | 25 | Day |
Published
https://www.jstage.jst.go.jp/article/circj/81/7/81_CJ-17-0109/_article
Completed
2014 | Year | 12 | Month | 26 | Day |
2015 | Year | 03 | Month | 09 | Day |
2016 | Year | 07 | Month | 05 | Day |
2016 | Year | 08 | Month | 31 | Day |
2015 | Year | 02 | Month | 25 | Day |
2018 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018555
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |