UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014635 |
|---|---|
| Receipt number | R000017025 |
| Scientific Title | Evaluation of L/N type Ca2+ channel blocker (cilnidipine) in hypertension complicated diabetes or sleep apnea syndrome ; Trial for the effects of improvementof arteriosclerosis and renal function. |
| Date of disclosure of the study information | 2014/07/24 |
| Last modified on | 2014/11/20 10:23:21 |
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Basic information
Public title
Evaluation of L/N type Ca2+ channel blocker (cilnidipine) in hypertension complicated diabetes or sleep apnea syndrome ; Trial for the effects of improvementof arteriosclerosis and renal function.
Acronym
Study of effects on renal function and blood pressure and hardening of the arteries by Cilnidipine.
Scientific Title
Evaluation of L/N type Ca2+ channel blocker (cilnidipine) in hypertension complicated diabetes or sleep apnea syndrome ; Trial for the effects of improvementof arteriosclerosis and renal function.
Scientific Title:Acronym
Study of effects on renal function and blood pressure and hardening of the arteries by Cilnidipine.
Region
| Japan |
Condition
Condition
Diabetes/Hypertension/Sleep apnea syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For hypertension patients complicated with sleep apnea or diabetes, to examine the impact arteriosclerosis and blood pressure, renal function for the administration of amlodipine or cilnidipine in this study. Study of effects on renal function and blood pressure and hardening of the arteries by Cilnidipine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
office blood presure
PWV
IMT
urinary albumin (diabetes only)
urinary LFAB-P
Key secondary outcomes
e-GFR
adiponectin
hs-CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observation of changes with a cilnidipine administration.
Interventions/Control_2
Observation of changes with a amlodipine administration.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hypertensive patients not reaching the
step-down goal, even the administration
of RAS inhibitors for more than three
months or no medication.
2) Diabetic nephropathy
3) Patients complicated with sleep apnea
syndrome.
Among the above-mentioned;
1)+2)+3) or 1)+2) or 1)+3)
Key exclusion criteria
1) Patients with Ca blocker taking.
2) Pregnancy, or patients who are its
possible.
3) Patients with a history of
hypersensitivity to Ca blocker.
4) Patients the physician judged
inappropriate to this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Wago |
Organization
Kanazawa Medical Clinic/Minatomirai clinic
Division name
Internal medicine
Zip code
Address
3F, 3-6-3, Minatomirai, Nishi-ku, Yokohama city, Kanagawa pref., Japan
TEL
045-664-6606
wagou-endo@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Wago |
Organization
Kanazawa Medical Clinic/Minatomirai clinic
Division name
Internal medicine
Zip code
Address
3F, 3-6-3, Minatomirai, Nishi-ku, Yokohama city, Kanagawa pref., Japan
TEL
045-664-6606
Homepage URL
wagou-endo@umin.ac.jp
Sponsor or person
Institute
Kanazawa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical Clinic
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
| 2014 | Year | 07 | Month | 24 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 07 | Month | 24 | Day |
Last modified on
| 2014 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017025
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
