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 hypertensio

• Conditions: Pulmonary arterial hypertension (PAH); MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-021960-14-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-03
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified