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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: 12 May 2014
Main ID:  EUCTR2010-021960-14-DE
Date of registration: 03/03/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharma AG
Public title: An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension
Scientific title: An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension
Date of first enrolment: 08/04/2011
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021960-14
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany Italy
Contacts
Name: Medizinischer Infoservice   
Address:  Roonstraße 25 90429 Nürnberg Germany
Telephone: +49018022323 00
Email: infoservice@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Medizinischer Infoservice   
Address:  Roonstraße 25 90429 Nürnberg Germany
Telephone: +49018022323 00
Email: infoservice@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
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 (> 5 mIU/mL).
3. Patients with left ventricular ejection fraction (LVEF) < 45%
4. Patients with thrombocytopenia, platelet count < 50 x10^9/L (50 x 10^3/µL).
5. Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160 mm Hg or diastolic pressure >90 mm Hg.
6. Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block.
7. Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS the subject agrees to comply with two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap plus spermicide) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child for at least three (3) months following the last study drug administration Periodic abstinence and withdrawal are not acceptable methods of contraception.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pulmonary arterial hypertension (PAH)
MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Intervention(s)

Trade Name: Glivec®
Product Code: QTI571
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Glivec®
Product Code: QTI571
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: • To evaluate the long-term safety and tolerability of QTI571 in patients with severe pulmonary arterial hypertension
Primary end point(s): Safety monitored via standard safety laboratories evaluations: ECG, echocardiogram; adverse event reporting; physical examination...
Secondary Objective: • To evaluate the long-term efficacy of QTI571 as measured by the changes in six minute walk distance (6MWD) compared with the measurement in study CQTI571A2102.
• To assess the time to clinical worsening (TTCW) endpoints including all cause mortality, overnight hospitalization for worsening of pulmonary arterial hypertension, worsening of WHO functional class by at least one level, or a drop in six minute walk distance (6MWD) by 15% both as a composite endpoint and by individual time to clinical worsening events.
• To assess the impact of QTI571 on Medical Resource Utilization.

Exploratory objective:
• To explore the long-term efficacy of QTI571 in any patients who can not tolerate 400mg but 200mg daily dose by measurement of 6MWD and TTCW.
Secondary Outcome(s)
Secondary ID(s)
CQTI571A2102E1
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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