臨床研究等提出・公開システム

Date of registration	Dec. 09, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221333

Scientific Title	A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
Public Title	Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

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	Pfizer Japan Inc.
	Address	clinical-trials@pfizer.com
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Pfizer Japan Inc.
	Address	clinical-trials@pfizer.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		35
Study Type		Interventional
Study Design	Study Design	Nonrandomized trial, Open, Single group
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Subject who completed the B1321052 study as planned
	Exclusion Criteria	1.Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening 2.Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.
	Minimum Age	16age old over
	Maximum Age	80age old under
	Gender	Both
Health Condition or Problem Studied		Pulmonary Arterial Hypertension
Intervention(s)		investigational material(s) Generic name etc : Sitaxentan sodium INN of investigational material : Sitaxentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : 100 mg, once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Number of participants with adverse events 2 years
Secondary Outcome		Clinical worsening Change from baseline in 6-minute walk distance Change from baseline in WHO functional class Change from baseline in NT-pro BNP 2 years

Primary Sponsor	Pfizer Japan Inc.
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-101370
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	July. 19, 2013	Detail	Changes
5	July. 19, 2013	Detail	Changes
4	June. 17, 2011	Detail	Changes
3	June. 17, 2011	Detail	Changes
2	Dec. 09, 2010	Detail	Changes
1	Dec. 09, 2010	Detail

List of change history