臨床研究等提出・公開システム

Date of registration	Dec. 24, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222341

Scientific Title	A phase 2, double-blind, randomized, safety and efficacy study of GE-145 versus Iohexol in subjects undergoing coronary angiography.
Public Title

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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		100
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	The subjects who will undergo coronary angiography with or without elective PCI.
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		The subjects undergoing coronary angiography
Intervention(s)		investigational material(s) Generic name etc : GE-145 INN of investigational material : Ioforminol（INN） Therapeutic category code : 721 X-ray contrast agents Dosage and Administration for Investigational material : Injection control material(s) Generic name etc : Iohexol INN of investigational material : Iohexol（INN） Therapeutic category code : 721 X-ray contrast agents Dosage and Administration for Investigational material : Injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Image quality Evaluation based on a criteria
Secondary Outcome		Safety Adverse events after the administration of the study drug

Primary Sponsor	DAIICHISANKYO 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-132391
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Jan. 28, 2015	Detail	Changes
3	Jan. 28, 2015	Detail	Changes
2	Dec. 24, 2013	Detail	Changes
1	Dec. 24, 2013	Detail

List of change history