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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005384
Receipt No. 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

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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
Email 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
Email narita@med.akita-u.ac.jp

Sponsor
Institute Akita University Garduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006383

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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