UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016201 |
|---|---|
| Receipt number | R000018797 |
| Scientific Title | Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2016/10/18 14:53:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism
Acronym
Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism
Scientific Title
Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism
Scientific Title:Acronym
Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify clinical significance of Primary aldosteronism whose plasma aldosterone concentration is within normal level.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical features and Cardio- and cerebro-vascular events
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who has diagnosed primary aldosteronism between January 2004 and December 2015
Patients who has diagnosed essential hypertension between January 2004 and December 2013
Key exclusion criteria
Non
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuhiro Kitamura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3742
tkitamura@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuhiro Kitamura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3742
Homepage URL
tkitamura@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
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
西宮市立中央病院 内科（兵庫県）
関西労災病院 内科（兵庫県）
NTT西日本大阪病院 内分泌代謝内科（大阪府）
国立病院機構 大阪南医療センター 内分泌代謝内科（大阪府）
千里中央クリニック（大阪府）
中尾内科クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients data, such as age, gender, body mass index, systolic blood pressure, diastolic blood pressure, number of antihypertensive classes, age of hypertension onset, duration of hypertension, cardiovascular risk factors and complications of CCV events were collected from medical records.
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018797
