Pulmonary arterial hypertension (PAH) MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Glivec®
Product Code: QTI571
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the long-term safety and tolerability of QTI571 in patients with severe pulmonary arterial hypertension;Secondary Objective: • To evaluate the long-term efficacy of QTI571 as measured by the changes in six minute walk distance (6MWD) compared with the measurement in study CQTI571A2102. • To assess the time to clinical worsening (TTCW) endpoints including all cause mortality, overnight hospitalization for worsening of pulmonary arterial hypertension, worsening of WHO functional class by at least one level, or a drop in six minute walk distance (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 Utilization. Exploratory objective: • To explore the long-term efficacy of QTI571 in any patients who can not tolerate 400mg but 200mg daily dose by measurement of 6MWD and TTCW. ;Primary end point(s): Safety monitored via standard safety laboratories evaluations: ECG, echocardiogram; adverse event reporting; physical examination... | — |
Countries
Germany, Italy
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed