EUCTR2009-012057-38-DE进行中（未招募）不适用
A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female 18 years of age or older
- •2) A current diagnosis of Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting: WHO Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH associated systemic sclerosis, PAH following one year repair of congenital heart defect (ASD, VSD or PDA), or PAH associated with diet therapies or other drugs
- •3) A PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies, including endothelin receptor antagonists (ERA), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for = 3 months. Background therapy doses must be stable for = 30 days except for warfarin and prostacyclin analogues ( = 30 days but doses can vary even within the month before enrollment)
- •4) WHO Functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies must be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject has been shown to be intolerant of prostacyclin analogues.
- •5) 6MWD = 150 meters and = 450 meters at screening. Distances of two consecutive 6MWTs should be within 15% of one another.
- •6) Ability to provide written informed consent by the patient or a legal guardian
- •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
排除标准
- •1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are
- •a. women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- •b. women whose partners have been sterilized by vasectomy or other means
- •c. two birth control methods.
- •2. pregnant or nursing (lactating) women,
- •3. have previously received treatment with imatinib
- •4. in treatment with chronic nitric oxide therapy
- •5. with a diagnosis of pre-existing severe lung disease including parasitic diseases affecting lungs, congenital abnormalities of the lungs, thorax or diaphragm or bronchial asthma that may significantly contribute to severity of PAH in the opinion of the investigator
- •6. with a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction If pulmonary capillary wedge pressure is not attainable,
- •then a left atrial pressure measurement may be used in its place
- •7. with a diagnosis of pulmonary artery or vein stenosis
- •8. with other diagnosis of PAH in WHO Diagnostic Group 1 or 1' are excluded including congenital systemic to pulmonary shunts (large, small that are not surgically repaired), portal hypertension, HIV infection, hereditary hemorrhagic telangiectasia, hemoglobinopathies, veno-occlusive disease)
- •9. With a diagnosis of PAH associated with: venous hypertension (WHO Diagnostic
- •Group II, including LVEF < 45%), hypoxia (WHO Diagnostic Group III), chronic
- •pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other
- •miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis,
- •histiocytosis X, lymphangiomatosis, compression of pulmonary vessels, glycogen
- •storage disease, Gaucher’s disease, myeloproliferative disorders).
- •9. with thrombocytopenia < 50 x109/L
- •10. with a history of left heart failure in the past 3 months
- •11. with ucontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic >90 mmHg
- •12. with hemoglobin < 100 g/L
- •13. with deficiencies of blood coagulation [for details, please report to the protocol]
- •14. with disseminated intravascular coagulation
- •15. with evidence of major bleeding or intracranial hemorrhage
- •16. with a history of elevated intracranial pressure
- •17. with a history of latent bleeding risk [for details, please report to the protocol]
- •18. with a history of moderate or greater hepatic insufficiency transaminase levels for details, please report to the protocol]
- •19. with a history of renal insufficiency
- •20. previous therapeutic radiation of lungs or mediastinum
- •21. with a history of sickle cell anemia
- •22. with a QTcF > 450 msec for males and > 470 msec for females at screening and baseline in the absence of right bundle branch block.
- •23. with a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter
- •24. having a syncope in the 3 months prior to the screening visit
- •25. with a history of Torsades de Pointes
- •26. with a history of long QT syndrome
- •27. having undergone atrial septostomy in the 3 months prior to the screening visit
- •28. having undergone radiofrequency catheter ablation for atrial or sinus arrhythmias in the 3 months prior to screening visit
- •29. with an advanced, severe, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations
- •30. with a history of immunodeficiency diseases, including HIV
- •31. with a known hypersensitivity to QTI571 or drugs similar to the study drug
- •32. with a disability that
研究者
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