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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014352
Receipt No. R000016705
Scientific Title Analysis of associations between high density lipoprotein structure and cholesterol efflux capacity in dyslipidemic patients treated with pitavastatin
Date of disclosure of the study information 2014/06/24
Last modified on 2015/12/24

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Basic information
Public title Analysis of associations between high density lipoprotein structure and cholesterol efflux capacity in dyslipidemic patients treated with pitavastatin
Acronym High-Draw Study
Scientific Title Analysis of associations between high density lipoprotein structure and cholesterol efflux capacity in dyslipidemic patients treated with pitavastatin
Scientific Title:Acronym High-Draw Study
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the association between HDL structure and cholesterol efflux capacity in dyslipidemic patients treated with pitavastatin once daily.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between cholesterol efflux capacity by HDL cholesterol and distribution of HDL subfractions and HDL proteins.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 (1)Patients who have LDL-C at least 140 mg/dL and fasting triglyceride <400 mg/dL, and does not receive treatment of anti-hyperlipidemic drugs
(2)Patients who can provide a fasting blood sample
(3)Patients over 20 years old
(4)Patients who voluntarily provide informed consent with sufficient comprehension after receiving sufficient explanation of this study.
Key exclusion criteria (1)Patients with contraindications to Livalo
(2)Patients under treatment of anti-hyperlipidemic drugs (previous treatment of statin within 3 months, probucol within 6 months, or other anti-hyperlipidemic drugs within 1 month)
(3)Previous treatments of hypertension excluding ARB, ACE inhibitor, and Ca blocker within 1 month
(4)Patients with CK over upper limit of normal levels
(5)Patients with AST and ALT over upper limit of normal levels
(6)Smokers
(7)Patients who cannot stop drugs prohibited for concomitant
(8)Obese patients with BMI at least 30 kg/m2
(9)Patients with Nephrotic syndrome or diabetes mellitus
(10)Patients with fasting plasma glucose at least 126 mg/dL or casual plasma glucose at least 200 mg/dL
(11)Patients with 2 hours plasma glucose after 75g glucose load at least 200 mg/dL
(12)Patients with HbA1c at least 6.5%
(13)Patients with homozygous familial hypercholesterolemia
(14)Patients under 20 years old
(15)Patients judged to be inappropriate for this study by the investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Suzuki
Organization Chu-NET
Division name Owariasahi clinic
Zip code
Address 2505-1 Harada, Higashi-daido-cho, Owariasahi, Aichi 488-0801, Japan
TEL 0120-330-634
Email chunet-office@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Sawada
Organization Chu-NET
Division name Office
Zip code
Address CLINICAL STUDY SUPPORT, Inc. 2-22-8 Chikusa, Chikusa-ku, Nagoya, Aichi 464-6321, Japan
TEL 0120-330-634
Homepage URL
Email chunet-office@umin.ac.jp

Sponsor
Institute Chu-NET
Institute
Department

Funding Source
Organization Kowa Company, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2014 Year 06 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 21 Day
Date trial data considered complete
2015 Year 04 Month 17 Day
Date analysis concluded
2015 Year 07 Month 01 Day

Other
Other related information Result was published at Japan Atherosclerosis Society

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2015 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016705

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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