UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001666
Receipt No. R000001971
Scientific Title Japanese evaluation between FormuLa of Azelnidipine and amlodipine add on olmesartan to Get antialbuminuric effect study
Date of disclosure of the study information 2009/01/29
Last modified on 2012/04/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Japanese evaluation between FormuLa of Azelnidipine and amlodipine
add on olmesartan to Get antialbuminuric effect study
Acronym Japanese evaluation between FormuLa of Azelnidipine and amlodipine
add on olmesartan to Get antialbuminuric effect study (J-FLAG)
Scientific Title Japanese evaluation between FormuLa of Azelnidipine and amlodipine
add on olmesartan to Get antialbuminuric effect study
Scientific Title:Acronym Japanese evaluation between FormuLa of Azelnidipine and amlodipine
add on olmesartan to Get antialbuminuric effect study (J-FLAG)
Region
Japan

Condition
Condition Hypertensive patients with albuminuria and diabetes (diabetic nephropathy)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare antialbuminuric effect between azelnidipine (8 to 16 mg/day) and amlodipine (2.5 to 5 mg/day) in combination with olmesartan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in urinary albumin/creatinine (Cr) ratio in spot urine from pretreatment period (average of 2 measured value) to 12 months of treatment
Key secondary outcomes 1. Percent changes in urinary albumin/Cr ratio from pretreatment period to each period of treatment. Urinary protein/Cr ratio is analyzed similarly to urinary albumin/Cr ratio.
2. Urinary liver-type free fatty acid-binding protein (L-FABP)
3. Urinary 8-hydroxydeoxyguanosine (8-OHdG)
4. Office blood pressure (BP) in outpatient clinic
5. Pulse rate
6. Serum Cr or estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum creatinine – 1.094 (multiply by 0.739 in female)
7. Cerebro-cardio-vascular events: cerebro-cardio-vascular mortality (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Azelnidipine (8 to 16 mg/day) is added in patients with olmesartan and target blood pressure (BP) is under 130/80 mmHg,
Interventions/Control_2 Amlodipine (2.5 to 5 mg/day) is added in patients with olmesartan and target BP is under 130/80 mmHg
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients fulfilled all the condition of the following in pretreatment period can participate
1. Outpatient systolic BP is >=130 mmHg and <180 mmHg, and/or outpatient diastolic BP is >=80 mmHg and <110 mmHg
2. Urinary albumin/Cr >=30 mg/g in spot urine
3. Fasting blood sugar >=126 mg/dL or treatment with antidiabetic agents
4. Serum Cr <=2.0 mg/dL
5. Age is >=20 and <80 year-old
6. Olmesartan (10 to 20 mg/day) is administered for more than 1 month and calcium channel blocker (CCB) is not given or more than 1 month.
7. Written informed consent is obtained based on written and oral explanation of physician in charge
Key exclusion criteria Patients who apply any of the flowing cannot participate
1. Hypertensive emergency that requires intravenous administration of antihypertensives
2. Nephritic syndrome (urinary protein >=3.5 g/day and serum total protein <=6.0 g/dL [or serum albumin <=3.0 g/dL])
3. Adminstration of contraindication drugs (angiotensin converting enzyme [ACE] inhibitor, angiotensin receptor blocker [ARB] other than olmesartan, CCB other than the assigned one, adrenocorticosteriod, immunosuppressant, azole antifungal agent [itraconazole, miconazole, etc.], HIV protease inhibitor [ritonavir, saquinqvir, indinavir, etc]) or long-term (>= 2 weeks) administration of non-steriod anti-inflammatory drugs (NSAID)
4. Past history of severe side effect of CCB, ARB, or ACE inhibitor
5. Cerebrovascular disease occurs within 6 months
6. Sever heart failure (NYHA class >= III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), myocardial infarction or percutaneous transluminal coronary angioplasty within 6 months
7. Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (>= 9.0), extremely high blood glucose, or diabetic ketoacidosis
8. AST or ALT is more than 5 times higher upper limits
9. Malignancy
10. Pregnant, possible to be pregnant, or willing to be pregnant
11. Patients who are inadequate by determination of physician in charge
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Fujita
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
TEL 03-5800-9735
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Ando
Organization University of Tokyo Graduate School of Medicine
Division name Division of Molecular Cardiovascular Metabolism
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan
TEL 03-5800-9119
Homepage URL
Email katsua-tky@umin.sc.jp

Sponsor
Institute J-FLAG Study Group
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan Inc.
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

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 29 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
2008 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 29 Day
Last modified on
2012 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.