UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004679 |
|---|---|
| Receipt number | R000005572 |
| Scientific Title | The examination of the effect of L/N type calcium channel blocker for L-FABP in hypertensive patients with coronary arteries disease. |
| Date of disclosure of the study information | 2010/12/07 |
| Last modified on | 2015/12/07 09:32:27 |
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Basic information
Public title
The examination of the effect of L/N type calcium channel blocker for L-FABP in hypertensive patients with coronary arteries disease.
Acronym
The examination of the effect of L/N type calcium channel blocker for L-FABP in hypertensive patients with coronary arteries disease.
Scientific Title
The examination of the effect of L/N type calcium channel blocker for L-FABP in hypertensive patients with coronary arteries disease.
Scientific Title:Acronym
The examination of the effect of L/N type calcium channel blocker for L-FABP in hypertensive patients with coronary arteries disease.
Region
| Japan |
Condition
Condition
Hypertensive patients with coronary arteries disease.
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of CCBs (Cilnidipine or Amlodipine) on L-FABP in hypertensive patients undergoing scheduled coronary angiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in urinary L-FABP
Key secondary outcomes
Incidence of CIN(A increase at least 0.5mg/dL or a relative increase of at least 25% from baseline value)
Blood pressure, heart rate, BUN, Cr(estimated GFR), proteinuria
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cilnidipine group
Interventions/Control_2
Amlodioine group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients(more than 140/90 mmHg or hypotensive agents treatment) undergoing scheduled coronary angiography.
Key exclusion criteria
1)Pregnancy or a patient with the possibility
2)History of hypersensitivity to CCBs
3)Malignant hypertension
4)Patients who are inadequate to enter this study due to the other reasons by physician's judgments.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Internal medicine, Division of Cardiology
Zip code
Address
132 katsura-cho, Sakae-ku, Yokohama, 247-8581, JAPAN
TEL
045-891-2171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Katoh |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Internal medicine, Division of Cardiology
Zip code
Address
132 katsura-cho, Sakae-ku, Yokohama, 247-8581, JAPAN
TEL
045-891-2171
Homepage URL
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
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
YES
Study ID_1
22077
Org. issuing International ID_1
Yokohama City University Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005572
