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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

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.]

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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