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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040373
Receipt No. R000046077
Scientific Title Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering by switching from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study).
Date of disclosure of the study information 2020/05/12
Last modified on 2020/05/17

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Basic information
Public title Prospective Study of Patients Switched from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study)
Acronym Switch from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study)
Scientific Title Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering by switching from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study).
Scientific Title:Acronym Switch fate Study
Region
Japan

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

Objectives
Narrative objectives1 Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering therapy by switching from arilocumab to evolocumab
Basic objectives2 Others
Basic objectives -Others Changes in LDL quantity and quality depending on the degree of LDL decline
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Lipid profile (TC,TG,HDL-C, Friedewald LDL-C,small dense LDL,IDL,Lp(a),LDL oxidation ability,LDL stability,oxidized LDL,3%PAGE,Agarose gel electrophoresis,electronegative LDL),apo protein, apoE phenotype
Key secondary outcomes Cr, BUN, Urinal analysis, GOT, GPT, CK, (following in the case of DM), fasting blood glucose, HbA1, hematologic changes such as thrombocytopenia, etc., early-phase and late-phase of allergic reaction to PCSK9 inhibitor.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Before switching from 75 mg, 150 mg arilocumab to 140 mg, 420 mg evolocumab, and 6 months and 1 year after the switch.
Interventions/Control_2 Evolocumab 140mg, 420mg continued: at start of intervention, 6 months after intervention, 1 year after intervention
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 1)-3) 3 examine group
1)T2DM with 120 mg/dl or more than 100 mg/dl LDL-C
2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 CategoryIII (Diabetes patients are excepted) with 120 mg/dl or more than 100 mg/dl LDL-C
3)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 Secondary prevention with 100 mg/dl or more than 70 mg/dl LDL-C
Key exclusion criteria A patient with the side-effects past in statin medication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ikuo
Middle name
Last name Inoue
Organization Saitama Medical University
Division name Dept. of Endocrinology and Diabetology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1875
Email i1901018@saitama-med.ac.jp

Public contact
Name of contact person
1st name Ikuo
Middle name
Last name Inoue
Organization Saitama Medical University
Division name Dept. of Endocrinology and Diabetology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1875
Homepage URL
Email i1901018@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Dept. of Endocrinology and Diabetology
Institute
Department

Funding Source
Organization Non
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 IRB
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel 049-276-1354
Email hirb@saitama-med.ac.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 埼玉医科大学

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 12 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
2020 Year 06 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 06 Month 01 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 12 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/05/13 A Sudden Onset of Severe Thrombocytopenia WhileUsing Evolocumab.pdf


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