EUCTR2006-005361-19-GB进行中（未招募）1 期
Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis
St Georges Hospital0 个研究点目标入组 45 人开始时间: 2006年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Any Patient with Chronic Obstructive Pulmonary Disease or Sarcoid with Pulmonary Hypertension. Pulmonary hypertension is defined as a mean pulmonary artery pressure in excess of 20mmHg at rest. Pulmonary hypertension is defined as an elevated mean pulmonary artery pressure of 20 mmHg or greater at rest or 30 mmHg with exercise.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Bosentan is contraindicated in patients with moderate to severe liver dysfunction and therefore this is an exclusion criteria.
- •There is limited experience with Bosentan in patients with a body weight below 40 kg, although this is not an absolute exclusion criteria this would require more frquent monintoring and is a relative contraindication for inclusion in the trial.
- •Excessive age is a relative contraindication given the number of clinic visits(>85 years old).
- •Children Safety and efficacy in patients under the age of 12 years have not been established so this is an exclusion criteria. (Age <12)
- •Pregnancy is absolute ecxlusion to the trial - therefore females entering the trial of child bearing age would need two forms of contraception and a pregnancy test prior to entry.
研究者
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