NCT01588405已完成2 期
A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
United Therapeutics6 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.
研究概览
简要总结
This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).
This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
- •Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
- •Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
- •Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline
排除标准
- •WHO functional class III and IV subjects will be excluded
研究组 & 干预措施
UT-15C SR
Experimental
干预措施: UT-15C SR (Drug)
结局指标
主要结局
Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.
时间窗: Up to 24 weeks
Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.
次要结局
- Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24(Baseline and week 24)
- Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)](Baseline and Week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)(Baseline and week 24)
- Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)(Baseline and Week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)(Baseline and Week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)(Baseline and week 24)
- Change From Baseline in Six-minute Walk Distance at Week 24(Baseline and week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)(Baseline and week 24)
- Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24(Baseline and week 24)
- Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24(Baseline and Week 24)
- Change in Dyspnea-fatigue Index From Baseline to Week 24(Baseline and Week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)(Baseline and week 24)
- Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)](Baseline and Week 24)
- Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)(Baseline and week 24)
研究者
研究点 (6)
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