EUCTR2012-001675-37-DE进行中（未招募）不适用
A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
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.Female and male patients of any racial origin with PAH (WHO classification II-III).
- •2.On stable treatment with best supportive care with conventional PAH therapy, i.e. anticoagulant drugs, diuretics, cardiac glycosides, supplemental oxygen and calcium channels blockers, adjusted to the individual need of the respective patient. Specific PAH mono-therapy (preferably with Bosentan) or combination-therapy (not exceeding two PAH specific drugs) with either endothelin receptor antagonists or phosphodiesterase type 5 inhibitors or non-sc/iv prostanoids (i.e. inhaled, oral). The dose of PAH specific therapy must be stable 3 months before entering the study and should remain unchanged throughout the study.
- •3.Having fulfilled his/her 18th birthday at Screening/Baseline Visit of the study but not older than 80 years (up to the patient's 81st birthday).
- •4.PAH due to idiopathic pulmonary arterial hypertension or connective tissue disease associated PAH
- •5.Right heart catheterisation 6 weeks prior to screening or at screening with PAH, specifically PAPm >25 mmHg (at rest), Pulmonary capillary wedge pressure (PCWP) =15 mmHg, pulmonary vascular resistance >500 dyn x sec x cm-5. Echocardiogram at screening consistent with PAH, specifically evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis.
- •6.Six minute walk distance = 200m.
- •7.Receiving conventional PAH therapy, stable for one month.
- •8.Able to understand and willing to sign the Informed Consent Form. Written informed consent must be given before any study procedure is performed
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.PAH of any cause other than permitted in the entry criteria
- •2.Contraindication for heart catheterisation
- •3.Any change in conventional PAH therapy within the last month before study start
- •4.Any change in PAH specific therapy within 3 months prior to study start
- •5.Patients requiring intravenous prostanoid therapy within 3 month prior to study start
- •6.Any subject who had received any investigational medication within 1 month prior to study start or who is scheduled to receive another investigational drug during the course of this study.
- •7.Known intolerance to lisuride.
- •8.Patients on concurrent treatment with phenylpropanolamin
- •9.Active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- •10.Chronic renal insufficiency as defined by a creatinine > 2.5 mg/dL or requires dialysis?
- •11.Obstructive or restrictive lung disease as evidenced by pulmonary function tests within 3 months before study entry, showing any of the following: VC < 65% of normal value, FEV1 < 65% of normal value
- •12.History of left heart disease, including any of the following: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, left ventricular ejection fraction < 55%
- •13.History of suspicion of inability to cooperate adequately
- •14.Psychiatric, addictive, or other disorder that compromises the ability to participating in this study?
- •15.Cancer or other malignant haematological disease
- •16.Pulmonary Hypertension caused by left heart disease
- •17.Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD)
- •18.Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV)
- •19.Portopulmonary Hypertension (PPHT)
- •20.CTEPH Chronic Thromboembolic Pulmonary Hypertension
- •21.Pulmonary Hypertension associated with other diseases excluding aforementioned: PAH due to idiopathic pulmonary arterial hypertension or connective tissue disease associated PAH including systemic sclerosis (sclerodermia) and systemic lupus erythematosus (SLE)
- •22.Pulmonary Hypertension associated with other chronic lung diseases
- •23.Patients on concurrent treatment with dopaminergic drugs
- •24.Women of child bearing potential must be excluded if:
- •they have not used reliable contraception in the cycle before the study. According to CPMP/ICH/286/95 (modification) highly effective methods of birth control (defined by a failure rate < 1% per year) include the consistent and correct use of implants, injectables, combined oral contraceptives, selected intrauterine devices (IUD), sexual abstinence or vasectomised partner. The subject has to agree to continue using such highly reliable contraception during the entire study period and the cycle after the study;
- •they are pregnant or lactating. (A negative pregnancy test must be provided for all women of reproductive age)
- •25.Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities?
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