A 12-Week, Randomized, Dose Response Study of UT-15C (Treprostinil Diethanolamine) SR in Patients With Exercise-Induced Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12
研究概览
简要总结
This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.
详细描述
Prospective, randomized, parallel group study with two periods: a 10 week, dose titration period, followed by a 2 week, dose maintenance period in patients with exercise-induced PH.
The study population will be randomized into Dose Group 1, Dose Group 2, or an Individual Maximum Tolerated Dose (iMTD) of UT-15C SR by Week 10 and maintained through Week 12. Patients may be either currently receiving an approved oral background therapy for their PH (phosphodiesterase-5 [PDE-5] inhibitor, OR endothelin receptor antagonist [ERA]) (no dual background therapy), or not currently receiving therapy for PH.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Group 1
UT-15C 0.25 mg twice daily
干预措施: UT-15C (Drug)
Dose Group 2
UT-15C 1.25 mg twice daily
干预措施: UT-15C (Drug)
Dose Group 3
UT-15C individual Maximum Tolerated Dose
干预措施: UT-15C (Drug)
结局指标
主要结局
Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12
时间窗: Baseline and Week 12
The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups. The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject's morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/\[L/min/m\^2\]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI).
次要结局
- Change in Mean Pulmonary Artery Pressure (PAPm) From Baseline to Week 12(Baseline and Week 12)
- Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 12(Baseline and Week 12)
- Change in 6-minute Walk Distance (6MWD) From Baseline to Week 12(Baseline and Week 12)
- Change in Cardiac Index (CI) From Baseline to Week 12(Baseline and Week 12)
- Change in PH Symptoms From Baseline to Week 12(Change from Baseline at 12 Weeks)
- Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 12(Change from Baseline at Week 12)
- Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 12(Baseline and Week 12)