UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013384 |
|---|---|
| Receipt number | R000015618 |
| Scientific Title | Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia. |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2016/12/27 11:00:25 |
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Basic information
Public title
Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia.
Acronym
Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia.
Scientific Title
Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia.
Scientific Title:Acronym
Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia.
Region
| Japan |
Condition
Condition
Hyperlipidemia with HDL-C <50mg/dL
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of pitavastatin on HDL-C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in HDL-C
Key secondary outcomes
Changes in lipid profile (TC, TG, LDL-C, non HDL-C).
Investigation of factors associated with Changes in HDL-C.
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
Pitavastatin for 6 months
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. Outpatients, 20 years old or above, regardless of sex.
2. HDL-C<50mg/dL
3.Patients who receive the treatment with statin (excluded to pitavastatin), or
patients who do not reach the target value of management in high LDL
cholesterolemia
4. Patients who are able to provide written informed consent.
Key exclusion criteria
1.Patients corresponding to the contraindication of pitavastatin
1)Known hypersensitivity to product components
2)Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels(Severe liver damage: AST, ALT >=500IU/L)
3)Co-administration with cyclosporine.
4)Pregnant women, patients who may become pregnant, or nursing mothers
2.Patients who wish to become pregnant
3.Patients who are considerd unsuitable for inclusion by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetology and Endocrinology
Zip code
Address
1-1Daigaku, Uchinada-Cho, Kahoku-Gun, Ishikawa 920-0293,Japan
TEL
076-286-2211
koya0516@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kuroshima |
Organization
Kanazawa Medical University
Division name
Diabetology and Endocrinology
Zip code
Address
1-1Daigaku, Uchinada-Cho, Kahoku-Gun, Ishikawa 920-0293,Japan
TEL
076-286-2211
Homepage URL
naipicrc@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Diabetology and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Diabetology and Endocrinology
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
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 | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015618
