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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004510
Receipt No. R000005354
Scientific Title Japan Home versus Office blood pressure Measurement Evaluation for Assessment of the effects of mono and combination irbesartan therapy on microaLBuminuria
Date of disclosure of the study information 2010/11/08
Last modified on 2015/06/25

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Basic information
Public title Japan Home versus Office blood pressure Measurement Evaluation for Assessment of the effects of mono and combination irbesartan therapy on microaLBuminuria
Acronym J-HOME-ALB study
Scientific Title Japan Home versus Office blood pressure Measurement Evaluation for Assessment of the effects of mono and combination irbesartan therapy on microaLBuminuria
Scientific Title:Acronym J-HOME-ALB study
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy on renal function (urinary albumin / creatinine ratio and estimated glomerular filtration rate), home blood pressure, and the safety among irbesartan combination therapies with amlodipine, efonidipine, or trichlormethiazide, or irbesartan monotherapy in patients of essential hypertension with microalbuminuria
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Difference of efficacy on change of early morning urinary albumin / creatinine ratio among three groups treated for eight weeks with amlodipine, efonidipine, or trichlormethiazide in hypertensive patients with positive spot urinary microalbumin whose blood pressure values underreach target blood pressure level after treatment with irbesartan
Key secondary outcomes 1) Efficacy of eight-week irbesartan monotherapy on home blood pressure, home hear rate, casual blood pressure, casual heart rate, urinary albumin / creatinine ratio, and laboratory test results including blood, urine, and physiological tests

2) Efficacy of eight-week therapy with amlodipine, efonidipine, or trichlormethiazide in addition to irbesartan on home blood pressure, home hear rate, casual blood pressure, casual heart rate, urinary albumin / creatinine ratio, and laboratory test results including blood, urine, and physiological tests

3) Efficacy of eight-week therapy with amlodipine, efonidipine, or trichlormethiazide in addition to irbesartan on change of electrocardiogram

4) Incidents of side effects, especially edema

5) Incidents of complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 - Irbesartan 200mg in morning, once daily
- Amlodipine 5mg in evening, once daily
- Treatment period: 8 weeks
Interventions/Control_2 - Irbesartan 200mg in morning, once daily
- Efonidipine 40mg in evening, once daily
- Treatment period: 8 weeks
Interventions/Control_3 - Irbesartan 200mg in morning, once daily
- Trichlormethiazide 1mg in morning, once daily
- Treatment period: 8 weeks
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) More than 35 years of age

2) Patient with essential hypertension, who has never been treated or has not treated within four weeks

3) Patient with average home mornig systolic blood pressure >= 135mmHg

4) Patient with spot urinary albumin / creatinine ratio >= 10 mg/g creatinine and <= 299 mg/g creatinine

5) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study

6) Patient with average home mornig systolic blood pressure >= 125mmHg after receving monotherapy with irbesartan 200mg for four weeks in addition to four-week monothrapy with irbesartan 100mg
Key exclusion criteria 1) Hypersensitivity to components of compounds of irbesartan, amlodipine, efonidipine, or trichlormethiazide

2) Past history of major cardiac events or intervention (e.g., myocardial infarction, stroke) within 6 months prior to the start of the study.

3) Secondary hypertension other than renal hypertension

4) Casual or home blood pressure >= 180 / 110 mgHG

5) Patient with severe renal disease (serum creatinine >=2.0 mg/dL), acute renal failure, hyponatremia, or hypokalemia

6) Severe hepatic disease (ALT >= 100 IU/L)

7) Cardiac failure (above NYHA grade II)

8) Cancer or poor-prognosis diseases

9) Uncontrolled diabetes mellitus (HbA1c >= 8%)

10) Pregnancy or breast feeding, or a female expecting to conceive within the study

11) Patient ineligible to this study due to other medical reasons
Target sample size 260

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yutaka Imai
Organization Tohoku University Graduate School
Division name Department of Planning for Drug Development and Clinical Evaluation
Zip code
Address 6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL 022-717-7770
Email rinsyo@mail.pharm.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yutaka Imai
Organization Tohoku University Graduate School
Division name Department of Planning for Drug Development and Clinical Evaluation
Zip code
Address 6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL 022-717-7770
Homepage URL
Email rinsyo@mail.pharm.tohoku.ac.jp

Sponsor
Institute J-HOME-ALB study group
Institute
Department

Funding Source
Organization Miyagi Kidney foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 宏人会中央クリニック(宮城県)、猪熊外科胃腸科医院(埼玉県)、江村胃腸科内科医院(岩手県)、たまきクリニック(宮崎県)、宮髙医院(大阪府)、広部クリニック(大阪府)、つがわ内科クリニック(福井県)、良田医院(大阪府)、木村内科医院(秋田県)、あしやハートクリニック(埼玉県)、高橋医院(青森県)、にのみや内科(大分県)、大石内科循環器科医院(静岡県)、あらい内科クリニック(福井県)、加登病院(石川県)、中山医院(栃木県)、真嶋医院(大阪府)、八木医院(埼玉県)、柳澤医院(千葉県)、横浜相鉄ビル内科医院(神奈川県)、三愛病院附属矢巾クリニック(岩手県)、矢吹医院(福島県)、松尾けんこうクリニック(宮城県)、はとりクリニック(神奈川県)、館腰クリニック(宮城県)、おおば医院(宮城県)、柴山クリニック(静岡県)、小板橋医院(群馬県)、東西クリニック仙台(宮城県)、内科クリニックすずき(岩手県)、中村外科医院(福島県)、岩崎内科医院(山口県)、やまもとクリニック(神奈川県)、高田内科クリニック(大阪府)、南中山内科クリニック(宮城県)、斎藤医院(埼玉県)、あきもとクリニック(宮城県)、たかい内科クリニック(大阪府)、勝谷医院(兵庫県)、山本内科医院(福井県)、はやし内科クリニック(大阪府)、もりい内科クリニック(大阪府)、渡辺内科医院(静岡県)、長崎市立市民病院(長崎県)、三菱重工長崎造船所病院(長崎県)、木町病院(宮城県)、内方医院(宮城県)、真室川町総合保健施設(山形県)、南口診療所(神奈川県)、田島医院(青森県)、宮川内科小児科医院(神奈川県)、まさこメディカルクリニック(山口県)、博愛医院(神奈川県)、清水クリニック(大阪府)、荒井中央クリニック(福島県)、小田消化器科内科クリニック(山形県)、泉川診療所(愛媛県)、伊藤内科クリニック(山形県)、青磁野リハビリテーション病院(熊本県)、岡本内科クリニック(群馬県)、長野市大岡診療所(長野県)、のしろクリニック(栃木県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2010 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 05 Day
Last modified on
2015 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005354

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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