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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004152
Receipt No. R000004983
Scientific Title Evaluation of guideline for primary hyperaldosteronism in Japan-2 Study
Date of disclosure of the study information 2010/09/03
Last modified on 2016/03/02

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Basic information
Public title Evaluation of guideline for primary hyperaldosteronism in
Japan-2 Study
Acronym PHAS-J2
Scientific Title Evaluation of guideline for primary hyperaldosteronism in
Japan-2 Study
Scientific Title:Acronym PHAS-J2
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 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1)Adherance of clinical guideline
2)Establishment of standard medication
Key secondary outcomes 1)Implementation rate of each diagnostic procedure
2)Successful rate of the localization
3) Comparison of the effects of treatments with aldosterone antagonist and those with conventional antihypertensive agents
4) 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
80 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 taking beta blocker or diuretics if not feasible to change to Ca antagonist or alfa antagonist
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 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto 612-8555, Japan
TEL 075-641-9161(6134)
Homepage URL
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
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
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 NHO函館病院(北海道)、NHO仙台医療センター(宮城県)、NHO西群馬病院(群馬県)、NHO高崎総合医療センター(群馬県)、NHO宇都宮病院(栃木県)、NHO水戸医療センター(茨城県)、NHO千葉東病院(千葉県)、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大阪医療センター(大阪府)、NHO大阪南医療センター(大阪府)、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関門医療センター(山口県)、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長崎医療センター(長崎県)、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)、五島中央病院(長崎県)、みさと健和病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 03 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 Completed
Date of protocol fixation
2010 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 31 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 02 Day
Last modified on
2016 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004983

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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