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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001739
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002092

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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