EUCTR2007-003975-38-AT进行中（未招募）不适用
Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
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-IV)
- •2.On stable treatment with best supportive care with anticoagulant drugs, diuretics, cardiac glycosides, supplemental oxygen and calcium channels blockers, adjusted to the individual need of the respective patient. Specific PAH mono-therapy (or combination-therapy not exceeding two PAH specific drugs) with either endothelin receptor antagonists or phosphodiesterase type 5 inhibitors or non-parenteral prostanoids (i.e. inhaled, oral, s.c.) is allowed (pre-treated patients) but not mandatory (treatment naive patients). Patients already on PAH specific drugs must be receiving a stable dose of the medication for at least 3 months
- •3.Having fulfilled his/her 18th birthday on Day 1 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.Cardiac catheterisation 4 weeks prior to screening or at screening with PAH, specifically PAPm >=25 mmHg (at rest), Pulmonary capillary wedge pressure (PCWP) <=16 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 above 150 m
- •7.Receiving conventional PAH therapy, stable for one month.
- •8.Presentation of negative test results in regard to HIV, Hepatitis C/B, not older than 4 weeks.
- •9.Able to understand and willing to sign the Informed Consent Form.
- •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.Pregnancy and/or lactation
- •2.PAH of any cause other than permitted in the entry criteria
- •3.Contraindication for heart catheterisation
- •4.Any change in disease-targeted therapy within the last month before screening
- •5.Patients requiring intravenous prostanoid therapy within 3 months prior to study start
- •6.Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
- •7.Known intolerance to Terguride
- •8.Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- •9.History or suspicion of inability to cooperate adequately .
- •10.Cancer or other malign haematological disease
- •11.Pulmonary Hypertension caused by left heart disease
- •12.Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD)
- •13.Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV)
- •14.Portopulmonary Hypertension (PPHT)
- •15.CTEPH Chronic Thromboembolic Pulmonary Hypertension
- •16.Pulmonary Hypertension associated with other diseases (i.e. Sarcoidosis, Histiocytosis, etc)
- •17.Pulmonary Hypertension associated with other chronic lung diseases
研究者
相似试验
进行中（未招募）
不适用
Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHPulmonary arterial hypertensionEUCTR2007-003975-38-NLErgonex Pharma GmbH84
进行中（未招募）
不适用
Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHPulmonary arterial hypertensionEUCTR2007-003975-38-DEErgonex Pharma GmbH99
进行中（未招募）
不适用
Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHMedDRA version: 9.1Level: LLTClassification code 10036727Term: Primary pulmonary hypertensionPulmonary arterial hypertensionEUCTR2007-003975-38-CZErgonex Pharma GmbH84
已完成
2 期
Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo. Having finished this proof-of-concept study it is intended that patients will continuously be treated in an open label extension on a voluntary basis.high pulmonary blood pressure10019280pulmonary arterial hypertensionNL-OMON35522ErgoNex Pharma GmbH10
进行中（未招募）
1 期
Proof of concept study to investigate the efficacy, safety and tolerability as well as the pharmacokinetics and pharmacodynamics of a newly developed patch containing follicle-stimulating hormone applied after laser poration of the skin in oocyte donors compared to standard stimulation with intramuscularly/subcutaneously administered urofollitropin.A single-center, multiple dose, open label proof of concept study.Healthy female oocyte donors of normal body weight (body mass index within 18 to 29 kg/m2), age from 20 to 30 years (inclusive), ultrasound of ovaries, normal endocrine status, non-smokerMedDRA version: 12.0Level: LLTClassification code 10021926Term: InfertilityMedDRA version: 12.0Level: LLTClassification code 10056204Term: In vitro fertilisationEUCTR2010-020559-29-CZPantec Biosolutions AG20