EUCTR2009-012057-38-FR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
适应症
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>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies, including endothelin receptor antagonists (ERA), phosphodiesterase 5 inhibitors (PDE5), or inhaled, intravenous or oral prostacyclin analogues for = 3 months. On stable background therapy doses for = 30 days except for warfarin ( = 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, 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
- •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
- •The following patients will be excluded from participation in the study:
- •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. pre-existing lung disease
- •6. with a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction
- •7. with a diagnosis of pulmonary artery or vein stenosis
- •8. with a diagnosis of chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV)
- •9. with deficient thrombocyte function, thrombocytopenia < 50 x109/L
- •10. with a history acute heart failure or chronic left sided heart failure
- •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, inherited or acquired blood coagulation disorders, factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, efficient coagulation due to auto-antibodies against coagulation factors such as in lupus anticoagulant
- •14. with disseminated intravascular coagulation (DIC)
- •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 such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
- •18. with a history of moderate or greater hepatic insufficiency transaminase levels > 4 times the upper limit of normal or a bilirubin > 2 times the upper limit of normal
- •19. with a history of renal insufficiency (serum creatinine > 200 µmol/l)
- •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
- •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 may prevent the patient from completing all study requirements and in particular, interfere with the 6MWD assessment
- •33. with a life expectancy of 6 months or less
- •34. having used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •35. with a history of malignancy of any organ system, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •36. With a diagnosis of Hepatitis B or C
- •37. With a history of alcohol abuse within 6 months of screening
- •38. With a history of
研究者
相似试验
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 - IMPRESEUCTR2009-012057-38-DEovartis Pharma Services AG200
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 - IMPRESPulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapiesMedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2009-012057-38-ATovartis Pharma Services AG200
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 - IMPRESPulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapiesMedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2009-012057-38-BEovartis Pharma Services AG200
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 - IMPRESPulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapiesMedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2009-012057-38-NLovartis Pharma AG200
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 - IMPRESPulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapiesMedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2009-012057-38-SEovartis Pharma Services AG200