UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001739 |
|---|---|
| Receipt number | R000002092 |
| Scientific Title | The influence of azelnidipine on plasma renin activity and plasma aldosterone concentration in hypertensive patients. |
| Date of disclosure of the study information | 2009/02/27 |
| Last modified on | 2009/02/27 12:00:34 |
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Basic information
Public title
The influence of azelnidipine on plasma renin activity and plasma aldosterone concentration in hypertensive patients.
Acronym
The influence of azelnidipine on PRA and PAC in HT.
Scientific Title
The influence of azelnidipine on plasma renin activity and plasma aldosterone concentration in hypertensive patients.
Scientific Title:Acronym
The influence of azelnidipine on PRA and PAC in HT.
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the influence of azelnidipine treatment on PRA and PAC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma renin activity, plasma aldosterone concentration
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PRA/PAC was measured in 10 of essential hypertensive patients. Then, 16 mg of azelnidipine a day was started to administer for 4 weeks. After this period, PRA/PAC was measured again.
Interventions/Control_2
PRA/PAC was measured in 10 of essential hypertensive patients who have been treated with amlodipine. Then, 16 mg of azelnidipine a day was started to administer in stead of amlodipine for 4 weeks. After this period, PRA/PAC was measured again.
Interventions/Control_3
PRA/PAC was measured in 10 of essential hypertensive patients who have been treated with manidipine. Then, 16 mg of azelnidipine a day was started to administer in stead of manidipine for 4 weeks. After this period, PRA/PAC was measured again.
Interventions/Control_4
PRA/PAC was measured in 10 of essential hypertensive patients who have been treated with nifedipine. Then, 16 mg of azelnidipine a day was started to administer in stead of nifedipine for 4 weeks. After this period, PRA/PAC was measured again.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Systolic blood pressure ; more than 140 mmHg or diastolic blood pressure; more than 90 mmHg
Key exclusion criteria
Secondary hypertension
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kondo |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-11-1-1, Honjo, Kumamoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-1, Honjo, Kumamoto
TEL
096-373-5169
Homepage URL
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kumamoto University
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
| 2009 | Year | 02 | Month | 27 | 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
Plasma rennin activity and plasm aaldosterone concentration were not altered during calcium channel antagonist, azelnidipine treatment in hypertensive patients.
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 27 | Day |
Last modified on
| 2009 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002092
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| Registered date | File name |
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| Registered date | File name |
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