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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014635
Receipt No. 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

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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
Email 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
Email wagou-endo@umin.ac.jp

Sponsor
Institute Kanazawa Medical Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017025

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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