NCT00034307Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
ICOS-Texas Biotechnology51 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2002年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 51
研究概览
简要总结
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.
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
- Double
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA Class II, III or IV
- •16 to 75 years of age
- •Specific peak VO2 range
- •PPH, PAH due to connective tissue disease or select congenital heart disease
- •Qualifying cardiac catheterization
- •History of CXR and qualifying pulmonary function test
- •History of qualifying ventilation-perfusion lung scan
- •History of qualifying echocardiogram
- •Women of childbearing potential must use contraceptives
- •Stable dose of corticosteroids if prescribed
排除标准
- •Significant lung disease
- •Chronic liver disease
- •Uncontrolled sleep apnea
- •History of specific types of left heart disease
- •Any disorder that compromises ability to give informed consent
- •Uncontrolled sleep apnea
- •Inability to perform bicycle exercise test
- •On-going treatment with an experimental drug or device within the last 30 days
- •HIV infection
- •Specific liver dysfunction
- •Chronic renal disease
- •Pregnancy/Nursing
- •Chronic active hepatitis B or C
- •Chronic Flolan or Tracleer use within the last 30 days
研究者
研究点 (51)
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