UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003323 |
|---|---|
| Receipt number | R000004036 |
| Scientific Title | Comparative study on the effects of calcium antagonists on central blood pressure |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/03/22 13:30:29 |
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Basic information
Public title
Comparative study on the effects of calcium antagonists on central blood pressure
Acronym
Azeldinipine study
Scientific Title
Comparative study on the effects of calcium antagonists on central blood pressure
Scientific Title:Acronym
Azeldinipine study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that the effect of azeldinipine on central blood pressure is similar to that of amlodipine.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AI,urinary protein,eGFR
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
azeldinipine
Interventions/Control_2
amlodipine
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among the patients with CKD, the subjucts of this test would be those with high blood pressure despite of antihypertensive treatent. Envelop method was used to devide into 2 groups. One group should take amlodipine, and the other group do azeldinipine.
Key exclusion criteria
Exclusion criteria would be uncontrolable
hypertension, sustained hypotension, rapid increase in serum creatinine, the start of renal replacement therapy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Takenaka |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Moro-hongo Moroyama Iruma Saitama Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Moro-hongo Moroyama Iruma Saitama Japan
TEL
Homepage URL
Sponsor or person
Institute
Saitama Medical Univeristy
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Univeristy
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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 12 | Day |
Last modified on
| 2012 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004036
