臨床研究等提出・公開システム

Date of registration	Aug. 12, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220801

Scientific Title	Early phase II clinical study with AT-877ER in patients with pulmonary arterial hypertension
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	Asahi Kasei Pharma Corporation
	Address	ct-info@om.asahi-kasei.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Asahi Kasei Pharma Corporation
	Address	ct-info@om.asahi-kasei.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	double-blind
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Aged 20 years and over at the time of consent (2) Able to be hospitalized at the start and the end of study treatment; however, subjects may be treated on both an inpatient and outpatient basis at the time of consent (3) Class I to III according to the World Health Organization (WHO) Pulmonary Hypertension Functional Classification at the time of consent
	Exclusion Criteria	(1) Use of catecholamines and/or PDE3 inhibitors for the treatment of cardiac failure at the time of consent (2) Serious cardiac disorder not caused by pulmonary arterial hypertension, such as angina pectoris, myocardial infarction and myocarditis (3) Previous participation in this study
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Pulmonary arterial hypertension
Intervention(s)		investigational material(s) Generic name etc : AT-877ER INN of investigational material : Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : The study drug will be administered twice a day, for 12 weeks, with a gradual dose escalation at the beginning of treatment and a gradual reduction toward the end. control material(s) Generic name etc : placebo-controlled comparative study INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : the same as described above
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	ASAHI KASEI PHARMA CORPORATION
Secondary Sponsor

Name of Funding Organization	Asahi Kasei Pharma Corporation
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-090830
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Aug. 14, 2014	Detail	Changes
6	Sept. 18, 2013	Detail	Changes
5	Aug. 07, 2012	Detail	Changes
4	Sept. 27, 2010	Detail	Changes
3	Sept. 27, 2010	Detail	Changes
2	Aug. 12, 2009	Detail	Changes
1	Aug. 12, 2009	Detail

List of change history