EUCTR2013-002783-12-AT进行中（未招募）1 期
A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 24
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 aged = 18 years.
- •2.Written informed consent given. [This consent must have been given before any study-specific procedures are conducted. A single informed consent form will cover both the main study, Parts 1–3, and the extension, Part 4.]
- •3.Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
- •4.Current inhalative therapy with 5 µg iloprost using the I Neb nebulizer.
- •5.WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost.
- •6.Hemodynamic diagnosis of PAH showing mean pulmonary arterial pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) < 15 mmHg and pulmonary vascular resistance (PVR) > 320 dyn•s•cm–5.
- •7.Ability to understand and follow study-related instructions.
- •8.If non-specific types of chronic treatment for PAH are being administered: Stable dosage of these for at least the 4 weeks up to screening.
- •9.If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these for at least the 3 months up to screening.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Related to pulmonary disease / PAH
- •1.PAH related to any etiology other than those specified in the inclusion criteria, especially pulmonary veno-occlusive disease (PVOD)
- •2.Documented evidence of thromboembolic disease (probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest computed tomography (CT) scan within the 3 years before the screening visit
- •3.Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease, COPD)
- •4.Receipt of atrial septostomy within the six months before the screening visit
- •Related to cardiovascular disease
- •5.Severe coronary heart disease or unstable angina
- •6.Myocardial infarction within the six months before the screening visit
- •7.Decompensated cardiac failure if not under close medical supervision
- •8.Severe arrhythmias
- •9.Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
- •10.Cerebrovascular events (e.g. transient ischemic attack or stroke) within 3 months before Screening Visit
- •11.Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
- •12.Systemic hypotension with systolic blood pressure < 85 mmHg
- •Related to other conditions
- •13.Hypersensitivity to the active substance or to any of the excipients
- •14.Conditions where the effects of Ventavis on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage)
- •15.Hepatic impairment (such as acute hepatitis, chronic active hepatitis, or liver cirrhosis Child-Pugh B, C)
- •16.Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL and/or the requirement for dialysis
- •17.Clinically relevant bleeding disorder or active bleeding
- •18.Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
- •19.Clinically relevant abnormal conditions (including laboratory values) at Screening Visit that, in the opinion of the investigator, would compromise the evaluation of the study drug
- •Related to prior and concomitant medication
- •20.Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before Screening Visit
- •21.Addition or dose change of non-specific type of chronic treatments for PAH such as calcium channel blockers, nitrates, digitalis, or diuretics within 4 weeks before Screening Visit
- •22.Treatment with an investigational drug or device which has not received regulatory approval within 4 weeks before Screening Visit or during study
- •23.Any kind of prostanoid other than those mentioned in inclusion criteria no. 9 within a period shorter than 5 half-lives before treatment
- •24.Pregnant or breastfeeding women
- •25.Woman of child-bearing potential who does not agree to use an adequate method of contraception, i.e. a combination of two effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study
- •26.Investigators, study staff, or their immediate families
- •27.Criteria which in the opinion of the investigator preclude participation for scientific r
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