臨床研究等提出・公開システム

Date of registration	May. 12, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222487

Scientific Title	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy
Public Title

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	Eli Lilly Japan K.K.
	Address	0120-360-605
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Males with proven DMD Ages 7-14 years inclusive Able to complete the six minute walk distance (6MWD) test with results within 20% of each other at a minimum of 2 pre-randomization assessments
	Exclusion Criteria
	Minimum Age	7age old over
	Maximum Age	14age old under
	Gender	Male
Health Condition or Problem Studied		Duchenne Muscular Dystrophy
Intervention(s)		investigational material(s) Generic name etc : Tadalafil INN of investigational material : Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : During the double-blind period, tadalafil or matching placebo will be administered orally once daily at one of 2 target doses (0.3 mg/kg or 0.6 mg/kg).During the open-label extension period all patients will initially receive tadalafil.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Eli Lilly Japan K.K.
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-142538
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
4	Dec. 17, 2018	(this page)	Changes
3	April. 15, 2016	Detail	Changes
2	May. 12, 2014	Detail	Changes
1	May. 12, 2014	Detail

List of change history