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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030932
Receipt No. R000035254
Scientific Title Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Date of disclosure of the study information 2018/01/23
Last modified on 2019/07/25

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Basic information
Public title Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Acronym Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Scientific Title Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Scientific Title:Acronym Optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Region
Japan

Condition
Condition Primary aldosteronism
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate optimal treatment strategy of mineralocorticoid receptor antagonists for primary aldosteronism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure
Urinary albumin
Key secondary outcomes QOL
eGFR

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Increase the dose of mineralocorticoid receptor antagonists (MRA) until serum K value reach to normal upper limit (serum K level 4.6-5.0 mEq/L) during 6 months visit (every 4-8 weeks). Basically not changing other antihypertention drugs. If the serum K value is less than 4.5mEq/L, increase MRA 25-50mg. If it is 4.6-5.0mEq/L, maintain at the same amount. If it is 5.1-5.4mEq/L, consider to decrease. If it is more than 5.5mEq/L, must to decrease.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients visiting our hospital with primary aldosteronism who agreed to participate in this study. Patients whoes systolic blood pressure is control under 200mmHg and diastolic blood pressure under 120mmHg.
Key exclusion criteria Patients who did not agree to this study, receiving sex hormone therapy, having heart diseases (NYHA 3 degree or higher), liver dysfunction (AST/ALT over 100IU/mL or T-Bil over 2.0mg/dL), renal dysfunction (Cr over 2.0mg/dL), serious diseases such as malignant diseases and judged inappropriate.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Otsuki
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2 Yamada-oka. Suita, Osaka, Japan
TEL 06-6879-3732
Email otsuki@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Saiki
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2 Yamada-oka. Suita, Osaka, Japan
TEL 06-6879-3732
Homepage URL
Email saiki-a@endmet.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 23 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
2018 Year 02 Month 01 Day
Anticipated trial start date
2018 Year 02 Month 14 Day
Last follow-up date
2019 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 22 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035254

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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