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: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Trade Name: Glivec®
Product Code: QTI571
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pha
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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
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 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.]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the long-term safety and tolerability of QTI571;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.;Primary end point(s): • Safety will be monitored by standard safety laboratories, ECG, echocardiogram, adverse event reporting. | — |
Countries
Austria, Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed