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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: 2 June 2014
Main ID:  EUCTR2009-018167-26-DE
Date of registration: 11/03/2010
Prospective Registration: Yes
Primary sponsor: Novartis Pharma AG
Public title: An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension
Scientific title: An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension
Date of first enrolment: 04/05/2010
Target sample size: 140
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018167-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no 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  
Phase: 
Countries of recruitment
Austria Belgium France Germany Italy Spain United Kingdom
Contacts
Name: Medizinischer Infoservice   
Address:  Roonstraße 25 90429 Nürnberg Germany
Telephone: +491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Name: Medizinischer Infoservice   
Address:  Roonstraße 25 90429 Nürnberg Germany
Telephone: +491802232300
Email: infoservice.novartis@novartis.com
Affiliation:  Novartis Pharma GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. Written informed consent must be obtained, from the patient or a legal guardian, before any assessment is performed.
2. Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol including all Study Completion assessments.
3. Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue, but performed all Study Completion assessments. (These patients will be eligible to enter the extension study 24 weeks after initial dosing in the core study CQTI571A2301).
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), or sponge with 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 a pulmonary capillary wedge pressure > 15 mm Hg at time of Study
Completion Assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place. [In France, left atrial pressure measurement may not be used in place of pulmonary capillary wedge pressure.]
4. Patients with LVEF < 45%
5. Patients with thrombocytopenia, platelet count < 50 x109/L(50 x 103/µL)
6. Patients with uncontrolled systemic arterial hypertension, systolic > 160 mm Hg or
diastolic >90 mm Hg
7. Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block (based on Visit 1 ECG if required to be performed).
8. Male subjects must be using two acceptable methods of contraception, (e.g a 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 in the three months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
9. [(France only) Patients for whom a lung transplant is indicated in the next 6 months.]



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
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: Film-coated tablet
INN or Proposed INN: IMATINIB MESYLATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Glivec®
Product Code: QTI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESYLATE
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
Primary end point(s): • Safety will be monitored by standard safety laboratories, ECG, echocardiogram, adverse event reporting.
Secondary Objective: • Continue to evaluate the long-term efficacy of QTI571 as measured by
the change in 6MWD from baseline.
• Continue to assess time to clinical worsening (TTCW) endpoints
including all cause
mortality, hospitalization for worsening PAH for at least overnight
(established by
external adjudication committee), worsening of WHO functional class, or
a drop in
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 utilisation

Exploratory objectives:
• To explore the long-term efficacy of QTI571 in any patients that are
not able to tolerate 400mg QD by measurement of 6MWD and TTCW.
• Compare the change from baseline in 6MWD and TTCW from time to
entrance into
extension study between patients treated with imatinib and placebo
during the core study CQTI571A2301.
Secondary Outcome(s)
Secondary ID(s)
2009-018167-26-AT
CQTI571A2301E1
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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