UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

J-HOME-ALB study group

Institute

Department

Personal name

Organization

Miyagi Kidney foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2010

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

11

Month

05

Day

Last modified on

2015

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005354