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

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ClinicalTrials.gov Identifier: NCT02042014
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Severe Pulmonary Arterial Hypertension Drug: QTI571 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model 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
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2014
Actual Primary Completion Date : October 17, 2016
Actual Study Completion Date : October 17, 2016


Arm Intervention/treatment
Experimental: QTI571
Participants will receive QTI571 during 3 years.
Drug: QTI571
QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: Approximately 2.9 years ]
    All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042014


Locations
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Japan
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site
Mitaka-city, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02042014    
Other Study ID Numbers: CQTI571AJP01
First Posted: January 22, 2014    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pulmonary arterial hypertension, QTI571, open label study
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases