UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Pitavastatin on high density lipoprotein cholesterol levels in hyperlipidemia.
Title of the study (Brief title)	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	Daisuke Koya
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
Address	1-1Daigaku, Uchinada-Cho, Kahoku-Gun, Ishikawa 920-0293,Japan
TEL	076-286-2211
Email	koya0516@kanazawa-med.ac.jp

Public contact
Name of contact person	Yuka Kuroshima
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
Address	1-1Daigaku, Uchinada-Cho, Kahoku-Gun, Ishikawa 920-0293,Japan
TEL	076-286-2211
Homepage URL
Email	naipicrc@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University Diabetology and Endocrinology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015618