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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032734
Receipt No. R000037273
Scientific Title Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia
Date of disclosure of the study information 2018/05/28
Last modified on 2018/05/27

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Basic information
Public title Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia
Acronym LOTORIGA study
Scientific Title Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia
Scientific Title:Acronym LOTORIGA study
Region
Japan

Condition
Condition hyperlipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To study the effect of LOTORIGA on cognitive function in patients with hyperlipidemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes cognitive function test score (Mini-mental state examination, Hasegawa dementia scale-revised, Severe impairment Battery), evaluation at 6 & 12 month after drug administration
Key secondary outcomes serum lipid (LDL-C, HDL-C, TG), BDNF, Erythrocyte membrane fatty acid composition, evaluation at 6 & 12 month after drug administration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prescribe Rotriga 2g per day or 4g per day for 1 year
Interventions/Control_2 observation without Rotriga for 1 year
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
60 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria patients diagnosed as having dyslipidemia (TG >= 150 mg/dl)
Key exclusion criteria patients with hemorrhage, prescription of EPA drug, anticoagulants, NSAIDs excluding Aspirin, anti-acetylcholine esterase, supplements such as DHA or Beta-carotene
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Yamaguchi
Organization Shimane University, Faculty of Medicine
Division name Department of Internal Medicine III
Zip code
Address 89-1 Enya-cho, Izumo
TEL 0853202198
Email yamagu3n@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Marina Ikeda
Organization Shimane University, Faculty of Medicine
Division name Department of Internal Medicine III
Zip code
Address 89-1 Enya-cho, Izumo
TEL 0853202198
Homepage URL
Email cos3571@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 27 Day
Last modified on
2018 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037273

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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