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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008553
Receipt No. R000010052
Scientific Title Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Date of disclosure of the study information 2012/07/30
Last modified on 2012/07/27

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Basic information
Public title Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Acronym Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Scientific Title Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Scientific Title:Acronym Randomized, closs-over study to compare the effect of cilnidipine and azelnidipine on microalbuminuria in patients with hypertension and chronic kidney disease
Region
Japan

Condition
Condition hypertensive patients with chronic kidney disease
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effect of cilnidipine and azelnidipine in association with reduction of urinary albumin-creatinine ratio in patients with hypertension and chronic kidney disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Urinary albumin-creatinie ratio(mg/g*Cr) after 12 and 24 weeks
Key secondary outcomes Clinical blood pressure and heart rate
Mean home blood pressure
Estimated glomerular filtration rate
Plasma Renin Activity, Plasma Aldosterone Concentration
Antihypertensive effect
Safety parameters
will be analized after 12 and 24 weeks

Base
Study type Interventional

Study design
Basic design Cross-over
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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 cilnidipine(initial dose is 10mg/day, 5-20mg/day)
Interventions/Control_2 azelnidipine(initial dose is 8mg/day, 4-16mg/day)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hypertension patients with chronic kidney disease (CKD)
*Chronic kidney disease is defined as either kidney damage or GFR<60ml/min/1.73m^2 for 3months.
Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies.

Patients who administer angiotensin receptor blocker(ARB) and amlodipine as calcium blocker.
Key exclusion criteria 1) Contraindication to calcium chanel blockers.
2) Patients who has already administered calcium channel blocker except for amlodipine.
3) Any serious comobidity(brain disease, heart disease, renal disease, hepatic disease)
4) The patients with pregnant or possibly pregnant
5) Sereous hypertension patients
6) Investigator judged as inappropriate for this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nakajima
Organization Mie University, Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174, Edobashi, Tsu-city, Mie, Japan
TEL (059)231-5015
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Taniguchi
Organization Mie University, Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174, Edobashi, Tsu-city, Mie, Japan
TEL (059)231-5015
Homepage URL
Email

Sponsor
Institute Department of Cardiology and Nephrology, Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology and Nephrology, Mie University, Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 30 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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 30 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
2012 Year 07 Month 27 Day
Last modified on
2012 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010052

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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