NL-OMON35522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. - TERPAH
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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. Right heart 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 minutes 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.
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 disease-targeted therapy within the last month before screening
- •4. Patients requiring intravenous prostanoid therapy within 3 months prior to study start
- •5. 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
- •6. Known intolerance to Terguride
- •7. Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- •8. History or suspicion of inability to cooperate adequately.
- •9. Cancer or other malign haematological disease
- •10. Pulmonary Hypertension caused by left heart disease
- •11. Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD)
- •12. Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV)
- •13. Portopulmonary Hypertension (PPHT)
- •14. CTEPH Chronic Thromboembolic Pulmonary Hypertension
- •15. Pulmonary Hypertension associated with other diseases excluding aforementioned: PAH due to idiopathic pulmonary arterial hypertension or tissue disease associated PAH, PAH associated with connective tissue disease including systemic sclerosis (sclerodermia) and systemic lupus erythematosus (SLE).
- •16. Pulmonary Hypertension associated with other chronic lung diseases
- •17. Additionally, women with 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 patients)
研究者
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