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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016629
Receipt No. 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

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Basic information
Public title Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics
Acronym NOCTURNE study
Scientific Title Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics
Scientific Title:Acronym NOCTURNE study
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in nocturnal systolic blood pressure(SBP) at home from 4 to 12 weeks after study start
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 (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 (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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular,Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL 0285-58-7344
Email kkario@jichii.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name NOCTURNE Research support Office
Organization NOCTURNE Research support Office
Division name Satt Co., Ltd.
Zip code
Address Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-5312-5026
Homepage URL
Email nocturne@sa-tt.co.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine/ SHIONOGI&CO.,LTD.
Institute
Department

Funding Source
Organization SHIONOGI&CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/81/7/81_CJ-17-0109/_article
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 09 Day
Last follow-up date
2016 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.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


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