UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -
Title of the study (Brief title)	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
Condition	Hypertension with proteinuria
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Saori Nishio
Organization	Hokkaido University Hospital
Division name	Department of Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
Email

Public contact
Name of contact person	Saori Nishio
Organization	Hokkaido University Hospital
Division name	Department of Medicine II
Address
TEL	011-706-5915
Homepage URL
Email	saorin@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Department account fund
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 10 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 16 Day
Last modified on	2017 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=R000005458