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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02042014
First Posted: January 22, 2014
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Condition Intervention Phase
Severe Pulmonary Arterial Hypertension Drug: QTI571 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: 3 years ]
    All Serious Adverse events will be evaluated and reported for all participants receiving QTI571.


Enrollment: 8
Actual Study Start Date: January 22, 2014
Study Completion Date: October 17, 2016
Primary Completion Date: October 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QTI571
Participants will receive QTI571 during 3 years.
Drug: QTI571
QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
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
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02042014     History of Changes
Other Study ID Numbers: CQTI571AJP01
First Submitted: January 17, 2014
First Posted: January 22, 2014
Last Update Posted: October 17, 2017
Last Verified: July 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pulmonary arterial hypertension, QTI571, open label study

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases