JRCT ID: jRCT2080222412
Registered date:03/03/2014
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | pulmonary arterial hypertension |
Date of first enrollment | 03/03/2014 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : QTI571 INN of investigational material : imatinib Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day |
Outcome(s)
Primary Outcome | Serious Adverse Events All Serious Adverse events will be evaluated and reported for all participants receiving QTI571 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Patient is receiving QTI571 for the treatment of PAH and is currently enrolled in the extension study (A2301E1) in Japan. 2. Patient is currently benefitting from the treatment with QTI571 in the opinion of the investigator. |
Exclude criteria | 1. Patient has been permanently discontinued from QTI571 study treatment in the parent study. 2. Concomitant use of oral vitamin K antagonist medication. |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-142462 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma K. K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |