UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005384 |
|---|---|
| Receipt number | R000006383 |
| Scientific Title | Comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with nephropathy. |
| Date of disclosure of the study information | 2011/04/06 |
| Last modified on | 2014/05/11 10:54:46 |
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Basic information
Public title
Comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with nephropathy.
Acronym
Comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with nephropathy.
Scientific Title
Comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with nephropathy.
Scientific Title:Acronym
Comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with nephropathy.
Region
| Japan |
Condition
Condition
hypertensive type-2 diabetic patients with nephropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comparison of the effects of cilnidipine and benidipine on urinary excretions of albumin and type-IV collagen in Japanese hypertensive type-2 diabetic patients with diabetic nephropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in urinary excretions of albumin and type-IV collagen between groups with either cilnidipine or benidipine
Key secondary outcomes
Changes in blood pressure and glycemic control
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
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
with cilnidipine for 24 weeks followed with benidipine for 24 weeks
Interventions/Control_2
with benidipine for 24 weeks followed with cilnidipine for 24 weeks
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
Japanese hypertensive type-2 diabetic patients with nephropathy
with renin-angiotensin system inhibitor and calcium antagonist (cilnidipine, benidipie or other) for more than 3 months without requirement of adding other antihypertensive agents
SBP<140 mmHg, DBP<90 mmHg
HbA1c < 9.0%
Key exclusion criteria
acute illness or malignant tumors
drug allergy
with pregnant or breast feeding, or candidates with such situations
patients who are judged as inappropriate for inclusion by their physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address
Hondo 1-1-1, Akita city, Japan
TEL
018-884-6769
narita@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University Garduate School of Medicine
Division name
Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address
Hondo 1-1-1, Akita city, Japan
TEL
018-884-6769
Homepage URL
narita@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Garduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 04 | Month | 06 | 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
| 2010 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 11 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 11 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006383
