UMIN-CTR Clinical Trial

Public title

Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Acronym

Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Scientific Title

Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Scientific Title:Acronym

Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Region

Japan

Condition

Hypertension with proteinuria

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects on vascular endothelial function and renal function of irbesartan compared with amlodipine in hypertensive patients with proteinuria

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV

Primary outcomes

Change in coronary vascular resistance measured by a PET (positron-emission tomography)

Key secondary outcomes

1) inulin clearance, 2) ambulatory blood pressure and heart rate, 3) blood test, urinary test and biomarker, 4) change in Flow mediated dilatation (FMD), 5) safety parameter

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

irbesartan

Interventions/Control_2

amlodipine

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) hypertensive patients, 2) urinary albumin-creatinine ratio 30mg/g*Cr or more within 6 months, 3) estimated glomerular filtration rate 70mL/min/1.73m2, 4) ambulatory systolic and/or diastolic blood pressure 130/80 mmHg or more, 5) written informed consent

Key exclusion criteria

1) history of anaphylaxis of irbesartan or amlodipine, 2) patients who did not receive an antihypertensive treatment with angiotensin II receptor blockers (ARB), angiotensin converting enzyme (ACE) inhibitors or rennin inhibitor before the enrollment, 3) secondary hypertension, 4) history of stroke, myocardial infarction or cardiovascular disease, 5) nephrosis, 6) genetic renal disease, 7) patients with nephritis treated by corticosteroids, 8) hepatic dysfunction, 9) moderate heart failure (New York heart Association classes II or more), 10) patients with cancer or severe disease, 11) uncontrolled diabetic mellitus (HbA1c 8.0% or more), 12) bronchial asthma, 13) pregnancy, 14) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Saori Nishio

Organization

Hokkaido University Hospital

Division name

Department of Medicine II

Zip code

Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Saori Nishio

Organization

Hokkaido University Hospital

Division name

Department of Medicine II

Zip code

Address

TEL

011-706-5915

Homepage URL

Email

saorin@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Department account fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

北海道大学病院（北海道）

Date of disclosure of the study information

2010

Year

11

Month

16

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

Terminated

Date of protocol fixation

2010

Year

10

Month

05

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

16

Day

Last modified on

2017

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=R000005458