NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220801

Registered date:12/08/2009

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedPulmonary arterial hypertension
Date of first enrollment12/08/2009
Target sample size
Countries of recruitment
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name
Address ct-info@om.asahi-kasei.co.jp
Telephone
E-mail
Affiliation Asahi Kasei Pharma Corporation
Scientific contact
Name
Address ct-info@om.asahi-kasei.co.jp
Telephone
E-mail
Affiliation Asahi Kasei Pharma Corporation