臨床研究等提出・公開システム

Date of registration	Nov. 02, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221294

Scientific Title	A phase 2 dose exploratory study of K-877
Public Title	A phase 2 dose exploratory study of K-877

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Kowa Co., Ltd.
	Address	ctrdinfo@kowa.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Kowa Co., Ltd.
	Address	ctrdinfo@kowa.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		192
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, parallel-group study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Dyslipidemia with high TG and low HDL-C
	Exclusion Criteria	The subject who need to be taken any other anti lipidemic agent
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Dyslipidemia
Intervention(s)		investigational material(s) Generic name etc : K-877 INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : Oral dose control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral dose Generic name etc : Fenofibrate INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : Oral dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		TG percent change at the completion of treatment Central laboratory test
Secondary Outcome		Percent changes of other lipid parameters at the completion of treatment Central laboratory test

Primary Sponsor	Kowa Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101331
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
10	Dec. 17, 2018	(this page)	Changes
9	May. 10, 2018	Detail	Changes
8	Oct. 17, 2011	Detail	Changes
7	Oct. 17, 2011	Detail	Changes
6	Mar. 04, 2011	Detail	Changes
5	Mar. 04, 2011	Detail	Changes
4	Nov. 30, 2010	Detail	Changes
3	Nov. 30, 2010	Detail	Changes
2	Nov. 02, 2010	Detail	Changes
1	Nov. 02, 2010	Detail

List of change history