Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 17, 2014
Last updated: September 21, 2016
Last verified: September 2016
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: 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:

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
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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.


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02042014

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 Identifier: NCT02042014     History of Changes
Other Study ID Numbers: CQTI571AJP01
Study First Received: January 17, 2014
Last Updated: September 21, 2016

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

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases processed this record on April 27, 2017