JRCT ID: jRCT2080220801
Registered date:12/08/2009
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Pulmonary arterial hypertension |
Date of first enrollment | 12/08/2009 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | ASAHI KASEI PHARMA CORPORATION |
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Secondary Sponsor | |
Source(s) of Monetary Support | Asahi Kasei Pharma Corporation |
Secondary ID(s) | JapicCTI-090830 |
Contact
Public contact | |
Name | |
Address | ct-info@om.asahi-kasei.co.jp |
Telephone | |
Affiliation | Asahi Kasei Pharma Corporation |
Scientific contact | |
Name | |
Address | ct-info@om.asahi-kasei.co.jp |
Telephone | |
Affiliation | Asahi Kasei Pharma Corporation |