UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008844 |
|---|---|
| Receipt number | R000010208 |
| Scientific Title | Evaluation of clinical guideline and establishment of evidence for the diagnosis and treatment of primary hyperaldosteronism in Japan. |
| Date of disclosure of the study information | 2012/09/05 |
| Last modified on | 2019/03/11 10:09:56 |
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Basic information
Public title
Evaluation of clinical guideline and establishment of evidence for the diagnosis and treatment of primary hyperaldosteronism in Japan.
Acronym
PHAS-J3
Scientific Title
Evaluation of clinical guideline and establishment of evidence for the diagnosis and treatment of primary hyperaldosteronism in Japan.
Scientific Title:Acronym
PHAS-J3
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Endocrine surgery |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adherence of clinical guideline and establishment of standard medication of primary adlosteronism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1)Adherance of clinical guideline for PA
2)Establishment of standard medication in PA and Aldosterone-rerated hypertension.
Key secondary outcomes
1)Implementation rate of each diagnostic procedure
2)Successful rate of the localization
3) Comparison of the effects of medical treatments and surgical treatment
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional antihypertensive agents with aldosterone antagonist
Interventions/Control_2
Conventional antihypertensive agents
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
Hypertensive patients in the outpatient clinics and hospitals, who full-fill the following 1) or 2) criteria:
1)treated hypertensive patients
2)untreated hypertensive patients with systolic blood pressure higher than 140mmHg or diastolic blood pressure higher than 90mmHg according to the guideline of the Japan Society of Hypertension
Key exclusion criteria
1)pregnant patients
2)patients taking aldosterone antagonist within the last one month
3)patients with the following diseases:
(1)secondary hypertension (renal hypertension,renovascular hypertension, primary aldosteronism, Cushing's syndrome, pheochromocytoma, etc)
(2)patients whom the attending doctors decides not suitable for the entry because of the unstable stage of the following complications: coronary diseases, arrhythmia, severe valvular diseases, cerebrovascular diseases, acute and chronic renal failure (serum Cr higher than 3mg/dl), acute and chronic liver diseases
4) Patients whom the attending doctor decides not suitable for the entry of the study.
Target sample size
2700
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhide |
| Middle name | |
| Last name | Naruse |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
612-8555
Address
1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL
075-641-9161
yawata.rinshokenkyubu@gmail.com
Public contact
Name of contact person
| 1st name | Mitsuhide |
| Middle name | |
| Last name | Naruse |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
6128555
Address
1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL
075-641-9161
Homepage URL
yawata.rinshokenkyubu@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Japan Endocrine Society
Name of secondary funder(s)
non
IRB Contact (For public release)
Organization
National Hospital Organization
Address
5-21,2, higashigaoka, meguro-ku, Tokyo, Japan
Tel
03-5712-5075
kenkyu2004@nho.hosp.go.jp
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
ＮＨＯ函館病院(北海道)、ＮＨＯ西群馬病院（群馬県）、ＮＨＯ埼玉病院(埼玉県)、ＮＨＯ金沢医療センター(石川県)、ＮＨＯ名古屋医療センター(愛知県)、ＮＨＯ三重病院(三重県)、ＮＨＯ三重中央医療センター(三重県)、ＮＨＯ京都医療センター(京都府)、ＮＨＯ神戸医療センター(兵庫県)、ＮＨＯ岡山医療センター(岡山県)、ＮＨＯ呉医療センター・中国がんセンター（広島県）、ＮＨＯ小倉医療センター(福岡県)、ＮＨＯ九州医療センター(福岡県)、ＮＨＯ長崎川棚医療センター（長崎県）、ＮＨＯ熊本医療センター(熊本県)、佐世保市立総合病院（長崎県）、みさと健和病院(埼玉県)、岡崎市民病院（愛知県）、伊勢赤十字病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 05 | 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
2641
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
on analysis
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
| 2012 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010208
