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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02042014
Date of registration:	17/01/2014
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharmaceuticals
Public title:	Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Scientific title:	An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment
Date of first enrolment:	January 22, 2014
Target sample size:	8
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02042014
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Japan

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH)
and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.

- Patient is currently benifitting form the treatment with QTI571 in the opinion of the
investigator.

Exclusion Criteria:

- Patient has been permanently discontinued from QTI571 study treatment in the parent
study.

- Concomitant use of oral vitamin K antagonist medication.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Severe Pulmonary Arterial Hypertension

Intervention(s)

Drug: QTI571

Primary Outcome(s)

Serious Adverse Events [Time Frame: Approximately 2.9 years]

Secondary Outcome(s)

Secondary ID(s)

CQTI571AJP01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	18/06/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02042014

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