Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

Severe Pulmonary Arterial Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042014
• Other study ID #: CQTI571AJP01
• Status: Completed
• Phase: Phase 3
• Start date: January 22, 2014
• Est. completion date: October 17, 2016

Study information

• Verified date: June 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Description:

This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 17, 2016
• Est. primary completion date: October 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Severe Pulmonary Arterial Hypertension

Intervention

Drug:
• QTI571
QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Mitaka-city	Tokyo
Japan	Novartis Investigative Site	Sendai-city	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.	Approximately 2.9 years