PER-057-08已完成未知
A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 7
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
- 12 至 90（—）
- 性别
- All
入选标准
- •Signed informed consent before initiating any procedure specific to the study.
- •Patients with symptomatic pulmonary arterial hypertension (PAH) in modified functional classes II to IV of WHO.
- •Patients with the following types of PAH: Idiopathic (IPAH); Family (FPAH)
- •The diagnosis of PAH confirmed by hemodynamic evaluation performed before randomization
- •Walking distance of 6 minutes (6MWD)> 50 m and <475 m.
- •Men or women> 12 years of age (women with pregnancy potential should have a negative pregnancy test before starting treatment and should use a reliable contraceptive method).
排除标准
- •PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher´s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy.
- •PAH associated with simple congenital systemic to pulmonary uncorrected shunts, and combined and complex systemic to pulmonary shunts, corrected or uncorrected.
- •PAH associated with significant venous or capillary involvement (PCWP> 15 mmHg), known pulmonary veno-occlusive disease and capillary pulmonary hemangiomatosis.
- •Persistent pulmonary hypertension in the newborn.
- •Pulmonary arterial hypertension of groups 2 to 5 of the Venice classification.
- •Moderate to severe obstructive pulmonary disease: volume volume in first second / forced vital capacity (FEV1 / FVC) <
- •70% and FEV1 <65% of the predicted value after the administration of a bronchodilator.
- •Moderate to severe restrictive pulmonary disease: total lung capacity (TLC) <60% of the predicted value.
- •Moderate to severe renal insufficiency, ie. Child-Pugh Classification B or C.
- •Serum aspartate aminotransferase (AST) and / or alaninaminotransferase (ALT)> 1.5 times the upper limit of normal.
- •Hemoglobin <75% of the lower limit of the normal range.
- •Systolic blood pressure <100 mmHg.
- •Acute or chronic physical impairment (other than dyspnea), which limits the ability to meet the requirements of the study.
- •Pregnant or lactating women.
- •Concomitant disease that puts life expectancy at risk <12 months.
- •Body weight <40 kg.
- •Any condition that avoids adherence to the protocol or therapy.
- •Cardiopulmonary rehabilitation program based on the recently initiated or planned short-term exercise (<8 weeks before randomization).
- •Treatment with endothelin receptor antagonists (ERAs) in the 3 months prior to randomization.
- •Systemic treatment in the week prior to randomization with cyclosporin A or tacrolimus, everolimus, sirolimus (calcineurin inhibitors or mTOR inhibitors).
- •Known hypersensitivity to drugs of the same class as the study drug, or to any of its excipients.
- •Treatment planned, or in progress, with another investigational drug in the month prior to randomization.
研究者
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