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 - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

Inclusion: Patients eligible for inclusion in this study have to fulfill the following criteria: Written informed consent must be obtained before any assessment is performed. Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol including all Study Completion assessments Patients who withdrew from the CQTI571A2301 study prematurely 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: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 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. 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) Patients with a pulmonary capillary wedge pressure > 15 mm Hg at time of Study Completion Assessments in QTI51A2301 LVEF < 45% Patients with thrombocytopenia, platelet count < 50 x109/L(50 x 103/µL) Patients with uncontrolled systemic arterial hypertension, systolic > 160 mm Hg or diastolic >90 mm Hg Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block Male subjects must be using two acceptable methods of contraception, (e.g spermicidal gel plus condom) 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. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

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

Related Trials