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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007440
Receipt No. R000008768
Scientific Title Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism
Date of disclosure of the study information 2012/03/05
Last modified on 2016/03/07

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Basic information
Public title Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism
Acronym New Quick Cortisol Assay during Adrenal Vein Sampling
Scientific Title Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism
Scientific Title:Acronym New Quick Cortisol Assay during Adrenal Vein Sampling
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 evaluate the usefulness of new quick cortisol assay during adrenal vein sampling(AVS) in patients with primary aldosteronism(PA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of AVS
Key secondary outcomes 1)effects on differential diagnosis of PA.
2)effects on turn-round time of AVS.
3)rares of complications
4)cost for new quick cortisol assay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 traditional AVS
Interventions/Control_2 AVS using quick cortisol assay
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with primary aldosteronism who are candidtes for surgery
Key exclusion criteria 1)patients with primary aldosteronism who are not candidtes for surgery
2)patients under dialysis or with serum creatinine >2.5 mg/dl in men or >2.0 mg/dl in women
3)pregnancy or breast feeding
4)with malignancy
5)with severe hypersensitivity or with corticoid therapy
6)inadequacy to participate in the study, as assessed by the investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyu Takeda
Organization Kanazawa University Graduate School of Medical Science
Division name Department of internal medicine
Zip code
Address Takara-machi 13-1, Kanazawa, Ishikawa 920-8641, Japan
TEL 076-265-2252
Email takeday@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yoneda
Organization Kanazawa University Graduate School of Medical Science
Division name Department of internal medicine
Zip code
Address Takara-machi 13-1, Kanazawa, Ishikawa 920-8641, Japan
TEL 076-265-2252
Homepage URL
Email endocrin@med.kanazawa-u.ac.jp

Sponsor
Institute Department of internal medicine,Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Department of internal medicine,Kanazawa University Graduate School of Medical Science
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
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 芳珠記念病院(石川県)、石川県立中央病院(石川県)、石川県済生会金沢病院(石川県)、浅ノ川総合病院(石川県)、 金沢社会保険病院 (石川県)、富山赤十字病院(富山県)、高岡市民病院(富山県)、厚生連高岡病院(富山県)、三田市民病院(兵庫県)、日本原発性アルドステロン協会に属する医療機関(石川県)  

Other administrative information
Date of disclosure of the study information
2012 Year 03 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
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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 05 Day
Last modified on
2016 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008768

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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