A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 34
- 主要终点
- Treatment-emergent Adverse Events
研究概览
简要总结
Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study mandated procedure,
- •Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
- •Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.
排除标准
- •Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- •Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
- •Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
- •Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
- •Pregnant or breast-feeding women,
- •Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
- •Systolic blood pressure < 95 mmHg,
- •Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- •Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
- •Clinically relevant bleeding disorder or active bleeding,
- •Known hypersensitivity to iloprost or any of its excipients.
研究组 & 干预措施
iloprost power 6
iloprost power 15
干预措施: iloprost (Drug)
iloprost power 15
iloprost power 15
干预措施: iloprost (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events
时间窗: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.
Number of adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug
时间窗: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.
Number of adverse events leading to discontinuation of study treatment
Treatment-emergent Serious Adverse Events
时间窗: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.
Number of serious adverse events
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
时间窗: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.
Number of patients with adverse events leading to discontinuation of study treatment
次要结局
未报告次要终点