UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004152
Receipt number 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 15:50:01

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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 or person

Institute

National Hospital Organization

Institute

Department

Personal name



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

Value
https://center6.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