NCT01077297终止2 期
Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
研究概览
简要总结
Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female patients 18 years of age or older
- •Patients with PAH according to one of the following subgroups of the Venice Classification Group 1:
- •Idiopathic (iPAH), or
- •Familial/heritable (FPAH), or
- •Associated (APAH) with collagen vascular disease
- •Modified NYHA functional class II-III
- •Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:
- •Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
- •Resting mean PVR ≥ 240 dyn•s•cm-5 and
- •Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
排除标准
- •Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
- •Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
- •Patients with body weight < 50 kg (110 lbs)
- •Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
- •Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
- •Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
- •Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
- •Patients who have received any investigational drugs within 28 days of Baseline
- •Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
- •Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
- •Life expectancy less than 12 months
- •Females who are lactating or pregnant or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after study drug intake
- •Known hypersensitivity to any of the excipients of the drug formulation
- •Patients with positive response to vasoreactivity test
研究组 & 干预措施
Tezosentan
Experimental
干预措施: Tezosentan (Drug)
结局指标
主要结局
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
时间窗: 30 minutes
次要结局
- Change in total pulmonary resistance (TPR) from Baseline to 30 min(30 minutes)
- Change in cardiac output (CO) from Baseline to 30 min(30 minutes)
- Change in PCWP from Baseline to 30 min(30 minutes)
- Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes(30 minutes)
- Change in mPAP from Baseline to 30 min(30 minutes)
- Change in cardiac index (CI) from Baseline to 30 min(30 minutes)
研究者
研究点 (5)
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