EUCTR2008-006441-10-AT进行中（未招募）1 期
A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH II)
SCIPHARM SáR0 个研究点目标入组 105 人开始时间: 2008年12月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- •Subject must be competent to understand the information given in the written informed consent and from the investigator and must sign and date the informed consent prior to any study mandated procedure.
- •Subject must be at least 18 years of age and could be of any ethnical origin
- •Women of child bearing potential must be surgically sterile or postmenopausal (amenorrhea for at least 12 months) or using an acceptable form of contraception. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used correctly such as, implants, injectables, oral contraceptive medications, sexual abstinence, or a vasectomised partner.
- •Subject must have a current diagnosis of CTEPH, as defined by the following criteria:
- •A test result of perfusion scintigraphy and pulmonary angiography and/or multislice CT not older than 6 months, consistent with the diagnosis CTEPH. In case of recurrent PH after PEA, test results from before the surgery are acceptable if a typical specimen was harvested during PEA substantiating the diagnosis of CTEPH.
- •A right heart catheterization, not older than 6 months, consistent with the diagnosis CTEPH but specifically with a PAPm of > 25 mmHg, and a PVR of > 300 dyn.s.cm-5
- •At least three months of effective anticoagulation therapy (without improvement/to exclude subacute pulmonary emboli)
- •Subject must have a CTEPH classified as severe, as defined by the following criteria:
- •An un-encouraged 6MWT of between 150 and 400 meters
- •Classification in the WHO/NYHA functional class III or IV
- •The subject must not be suitable to undergo a PEA and is therefore defined as non-operable, due to at least one of the following reasons:
- •Clot is not accessible
- •Discrepancy between severity of PH and morphologic lesion
- •Subject is not a good surgical candidate for other reasons:
- •PVR > 1500 dynes.s.cm-5
- •Comorbidity
- •No functional lung parenchyma
- •Unsuccessful PEA in the past with residual/recurrent CTEPH
- •No consent for PEA given by the patient
- •Subject must be willing and able to follow all study procedures
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Subject with any form of pulmonary arterial hypertension or any disease known to cause PAH (WHO Group I)
- •Subjects with a total lung capacity (TLC) of < 70% predicted or a forced expiratory volume/forced capacity (FEV1/FVC < 50%)
- •Subject who received any prostanoids, within the 30 days before screening or be scheduled to receive prostanoids during the course of the study
- •Subject with a new type of chronic therapy (a different category of vasodilator or diuretic) for
- •PAH added within the last month, except anticoagulants
- •Subject with an increased risk for hemorrhage or stroke or with a major cardiovascular event during the past 6 months.
- •Unstable subjects for any reason (according to the investigators discretion)
- •Subject who received any investigational medication within 30 days prior to the screening visit of this study or be scheduled to receive another investigational drug during the course of this study
- •Subject with a known intolerance to any drug, relevant for this study especially to Treprostinil sodium or prostanoids
- •Subject with a history or suspicion of non compliance
- •Have any musculoskeletal disease or any other disease that would limit ambulation
- •Subject with other cardiovascular, liver, renal, hematologic, gastrointestinal immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and /or efficacy of the study drug or limit the lifespan of the subject
- •Female who is considering pregnancy or who is pregnant and/or lactating
- •Subject who is an investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
- •Subject who is an inmate of a psychiatric ward, prison or is suspected not to be able to give consent of his free will
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of Treprostinil which will becontinuously administered under the skin by patients with inoperableChronic Thromboembolic Pulmonary Hypertension.EUCTR2008-006441-10-CZSCIPHARM SáR105
进行中（未招募）
1 期
A double blind, placebo controlled study to investigate the role of NMDA receptor NR2B subunit selective antagonism on cognitive functions and neurophysiology in healthy subjects as measured with MRI - The effects of a novel NMDA NR2B-subtype selective antagonist, EVT 101, on brain functioEUCTR2007-000986-40-GBEvotec NeurosciencesGmbH20
进行中（未招募）
不适用
Double blind randomised controlled trial to investigate the efficacy of ANTOX (version 1.2) and MGCT (Magnesium) for the treatment of hereditary and idiopathic chronic pancreatitisHereditary or idiopathic chronic pancreatitisDigestive SystemDisorders of gallbladder, biliary tract and pancreasISRCTN44912429The University of Liverpool Clinical Trials Unit (UK)295
进行中（未招募）
1 期
A clinical trial investigating the effect of the anti-depressant fluoxetine on learning and memory in people with epilepsy.Mesial Temporal Lobe EpilepsyMedDRA version: 18.0 Level: PT Classification code 10043209 Term: Temporal lobe epilepsy System Organ Class: 10029205 - Nervous system disordersEUCTR2014-005088-34-GBCardiff University60
已完成
不适用
A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteersBacterial infections10004018NL-OMON43462Wockhardt Bio AG55