UMIN-CTR Clinical Trial

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
Last 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
Email	yawata.rinshokenkyubu@gmail.com

Public contact
1st 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
Email	yawata.rinshokenkyubu@gmail.com

Sponsor
Institute	National Hospital Organization
Institute
Department

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
Email	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
Oucome 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010208