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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 9 December 2013
Main ID:  EUCTR2013-001100-10-ES
Date of registration: 12/11/2013
Prospective Registration: Yes
Primary sponsor: Novartis Farmacéutica, S.A.
Public title: This study is to allow continued access to QTI571 for patients who received QTI571 for pulmonary arterial hypertension in one of the long-term extension studies (A2301E1, A2102E1 and E2203) and have been judged by the investigator to benefit from continued QTI571 treatment.
Scientific title: An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment
Date of first enrolment: 12/11/2013
Target sample size: 81
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001100-10
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Australia Spain Switzerland United States
Contacts
Name: Departamento Médico (ICRO)   
Address:  Gran Vía de les Corts catalanes, 764 08013 Barcelona Spain
Telephone: 34900353036
Email: eecc.novartis@novartis.com
Affiliation:  Novartis Farmacéutica, S.A.
Name: Departamento Médico (ICRO)   
Address:  Gran Vía de les Corts catalanes, 764 08013 Barcelona Spain
Telephone: 34900353036
Email: eecc.novartis@novartis.com
Affiliation:  Novartis Farmacéutica, S.A.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patient is receiving QTI571 for the treatment of PAH and is currently enrolled in a longterm extension study (CSTI571E2203, CQTI571A2301E1, and CQTI571A2102E1).
2. Patient is currently benefitting from the treatment with QTI571 in the opinion of the investigator.
3. Written informed consent must be obtained prior to enrolling into the QTI571A2314
study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion criteria:
1. Patient has been permanently discontinued from QTI571 study treatment in the parent extension study.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
3. Concomitant use of oral vitamin K antagonist medication.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pulmonary Arterial Hypertension
MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Current Sponsor code: QTI571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To provide continued treatment to PAH patients who are benefitting from treatment with QTI571
Primary end point(s): Not applicable
Secondary Objective: To collect long term data on serious adverse events.
Timepoint(s) of evaluation of this end point: Not applicable
Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
CQTI571A2314
Source(s) of Monetary Support
Novartis Pharma AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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