UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014352 |
|---|---|
| Receipt number | 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 09:11:42 |
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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
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
chunet-office@umin.ac.jp
Sponsor or person
Institute
Chu-NET
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016705
